A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis
Phase: PHASE2
Conditions: Sarcoidosis, Pulmonary
Sponsor: Kinevant Sciences GmbH

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024
Confidential 
Page 1 
 
 
CLINICAL STUDY PROTOCOL 
Study Title: 
A Randomized, Double-blind, Placebo-controlled Phase 2 Study 
with Open-label Extension to Assess the Efficacy and Safety of 
Namilumab in Subjects with Chronic Pulmonary Sarcoidosis 
Protocol Number: 
KIN-1902-2001 
Study Name: 
RESOLVE-Lung 
NCT#: 
05314517 
EudraCT#: 
2021-004794-31 
EUCT # 
2024-511115-25-00 
Universal Trial Number: 
U1111-1302-2991 
Compound Name and/or 
Number: 
Namilumab 
Sponsor: 
Kinevant Sciences GmbH (“KSG”), a Swiss Limited Liability 
Company, is the Sponsor of this study. Kinevant Sciences, Inc., 
(“KSI”), a Delaware corporation and an affiliate of KSG, has been 
engaged by KSG to manage the day‑to‑day operations of the 
study. All references to “Sponsor” contained herein shall refer to 
KSI, acting pursuant to a services agreement with KSG. 
Kinevant Sciences GmbH 
Viaduktstrasse 8 
CH-4051 Basel, Switzerland 
Kinevant Sciences, Inc. 
151 West 42nd Street, 15th floor 
New York, NY, 10036, USA 
Development Phase: 
2 
Indication: 
For the treatment of chronic pulmonary sarcoidosis 
Current Version and 
Effective Date: 
Version: 3.0 
Amendment 2 
13-May-2024
Study Director: 
 
Phone: 
  
Email: 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document, particularly unpublished data, is the property or under 
control of Sponsor, and is provided to you in confidence as an Investigator, potential Investigator, or 
consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent 
Ethics Committee. The information is only to be used by you in connection with authorized clinical 
PPD
PPD
PPD

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 2 
studies of the investigational drug described in the protocol. You will not disclose any of the information 
to others without written authorization from Sponsor, except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 3 
SPONSOR SIGNATURE PAGE 
Study Title:  A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label 
Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary 
Sarcoidosis 
 
Protocol Number:  KIN-1902-2001 
 
This protocol has been approved by a representative of Kinevant Sciences. The following 
signature documents this approval. 
 
 
 
 
 
 
 
Date 
 
 
PPD

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 4 
INVESTIGATOR SIGNATURE PAGE 
Study Title:  A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label 
Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary 
Sarcoidosis 
 
Protocol Number:  KIN-1902-2001 
 
• I confirm agreement to conduct the study in compliance with the protocol. 
• I acknowledge that I am responsible for overall study conduct. I agree to personally 
conduct or supervise the described study. 
• I agree to ensure that all associates, colleagues, and employees assisting in the conduct of 
the study understand their obligations and will comply with the study protocol. 
Mechanisms are in place to ensure that site staff receives the appropriate training and 
information throughout the study. 
 
 
 
 
Principal Investigator Name (Printed) 
 
Signature 
 
 
 
Date 
 
Site 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 5 
TABLE OF CONTENTS 
itle Page ........................................................................................................................................................ 1 
Sponsor Signature Page .............................................................................................................................. 3 
Investigator Signature Page ....................................................................................................................... 4 
Table of Contents ........................................................................................................................................ 5 
List of Tables ............................................................................................................................................... 8 
List of Figures .............................................................................................................................................. 8 
Protocol Synopsis ........................................................................................................................................ 9 
List of Abbreviations ................................................................................................................................ 20 
1. 
Introduction ...................................................................................................................................... 26 
1.1. 
Study Rationale ......................................................................................................................... 26 
1.2. 
Background ................................................................................................................................ 26 
1.3. 
Benefit-Risk Assessment ........................................................................................................... 29 
2. 
Objectives and Endpoints ................................................................................................................ 33 
2.1. 
Objectives .................................................................................................................................. 33 
2.2. 
Endpoints ................................................................................................................................... 34 
3. 
Investigational Plan .......................................................................................................................... 35 
3.1. 
Overall Study Design and Plan Description .............................................................................. 35 
3.1.1. 
Screening Period ............................................................................................................... 39 
3.1.2. 
26-Week Double-blind Treatment Period ......................................................................... 39 
3.1.3. 
Open-label Extension Period ............................................................................................ 39 
3.1.4. 
Follow-up Period .............................................................................................................. 40 
3.1.5. 
Unscheduled Visits ........................................................................................................... 40 
3.1.5.1. 
Rescue Visit ........................................................................................................................................................... 40 
3.2. 
Discussion of Study Design, Including the Choice of Control Group ....................................... 41 
3.3. 
End of Study Definition ............................................................................................................. 41 
3.4. 
Selection of Doses in the Study ................................................................................................. 41 
4. 
Selection of Subject Population....................................................................................................... 42 
4.1. 
Inclusion Criteria ....................................................................................................................... 42 
4.2. 
Exclusion Criteria ...................................................................................................................... 44 
4.3. 
Disease Diagnostic Criteria ....................................................................................................... 46 
4.4. 
Discontinuation Criteria ............................................................................................................ 47 
4.4.1. 
Screen Failures .................................................................................................................. 47 
4.4.2. 
Discontinuation of Study Treatment ................................................................................. 47 
4.4.2.1. 
Permanent Cessation of Study Drug .............................................................................................................. 47 
4.4.2.2. 
Temporary Cessation of Study Drug ............................................................................................................. 48 
4.4.2.3. 
Follow-up for Subjects Who Are Withdrawn from Study Drug .......................................................... 48 
4.4.2.4. 
Subject Discontinuation/Withdrawal of Consent ...................................................................................... 48 
4.4.2.5. 
Liver Injury ............................................................................................................................................................ 49 
4.4.2.6. 
Cardiac Changes ................................................................................................................................................... 50 
4.4.2.7. 
Pregnancy ............................................................................................................................................................... 51 
4.4.3 
Lost to Follow-up .............................................................................................................. 51 
4.4.4. 
Subject Replacement ......................................................................................................... 51 
4.5. 
Study Termination ..................................................................................................................... 51 
4.5.1. 
Early Termination of the Study......................................................................................... 51 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 6 
4.5.2. 
Early Termination of a Study Center ................................................................................ 52 
5. 
Study Treatment .............................................................................................................................. 53 
5.1. 
Treatments Administered .......................................................................................................... 53 
5.2. 
Preparation, Storage, Handling, and Accountability ................................................................. 54 
5.2.1. 
Return of Study Drug ........................................................................................................ 54 
5.2.2. 
Destruction of Study Drug ................................................................................................ 54 
5.3. 
Treatment Assignment and Administration ............................................................................... 55 
5.3.1. 
Dose Modification ............................................................................................................ 55 
5.3.2. 
Mobile Health Professional............................................................................................... 55 
5.4. 
Blinding ..................................................................................................................................... 56 
5.5. 
Treatment Compliance .............................................................................................................. 56 
5.5.1. 
Study Drug Compliance .................................................................................................... 56 
5.5.2. 
Oral Corticosteroid Use and Taper Compliance ............................................................... 56 
6. 
Concomitant Therapies and Other Restrictions ........................................................................... 57 
6.1. 
Concomitant Therapy ................................................................................................................ 57 
6.2. 
Prohibited Medications/Therapies ............................................................................................. 57 
6.3. 
Contraception ............................................................................................................................ 58 
6.4. 
Rescue........................................................................................................................................ 59 
7. 
Study Assessments and Procedures ................................................................................................ 61 
7.1. 
Radiographic Assessments ........................................................................................................ 61 
7.1.1. 
High-Resolution Computed Tomography ......................................................................... 62 
7.1.2. 
[18-F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET)/ Computed 
Tomography (CT) .............................................................................................................................. 62 
7.2. 
Efficacy Assessments ................................................................................................................ 63 
7.2.1. 
Pulmonary Function Tests ................................................................................................ 63 
7.2.1.1. 
Spirometry .............................................................................................................................................................. 63 
7.2.1.2. 
DLco Testing ......................................................................................................................................................... 63 
7.2.2. 
Patient Reported Outcomes............................................................................................... 64 
7.2.2.1. 
Saint George’s Respiratory Questionnaire .................................................................................................. 65 
7.2.2.2. 
Modified King's Sarcoidosis Questionnaire................................................................................................ 65 
7.2.2.3. 
Subject Global Assessment .............................................................................................................................. 65 
7.2.2.4. 
Leicester Cough Questionnaire ....................................................................................................................... 65 
7.2.2.5. 
Bothersomeness and Subject Global Impression of Change ................................................................. 66 
7.2.3. 
Clinician Reported Outcomes ........................................................................................... 66 
7.2.3.1. 
Extrapulmonary Physician Organ Severity Tool ...................................................................................... 67 
7.2.4. 
Cytokine, Chemokine, and Sarcoidosis Biomarker Analyses ........................................... 67 
7.3. 
Safety Assessments ................................................................................................................... 67 
7.3.1. 
Vital Signs, Height, and Body Weight .............................................................................. 67 
7.3.1.1. 
Vital Signs .............................................................................................................................................................. 67 
7.3.1.2. 
Height ....................................................................................................................................................................... 68 
7.3.1.3. 
Body Weight .......................................................................................................................................................... 68 
7.3.2. 
Physical Examinations ...................................................................................................... 68 
7.3.3. 
Electrocardiograms ........................................................................................................... 68 
7.3.4. 
Tuberculosis Screening ..................................................................................................... 69 
7.3.5. 
HIV and Hepatitis Screening ............................................................................................ 69 
7.3.6. 
Clinical Safety Laboratory Assessments .......................................................................... 69 
7.3.7. 
Sample Requirements ....................................................................................................... 70 
7.3.8. 
Pregnancy Testing ............................................................................................................. 72 
7.4. 
Adverse and Serious Events ...................................................................................................... 72 
7.4.1. 
Adverse Events ................................................................................................................. 72 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 7 
7.4.2. 
Reporting Serious Adverse Events ................................................................................... 73 
7.4.3. 
Pregnancy.......................................................................................................................... 74 
7.5. 
Pharmacokinetic Analysis ......................................................................................................... 74 
7.6. 
Immunogenicity Analysis .......................................................................................................... 74 
8. 
Sample Size And Data Analyses...................................................................................................... 75 
8.1. 
Determination of Sample Size ................................................................................................... 75 
8.2. 
Analysis Populations ................................................................................................................. 75 
8.2.1. 
Intent-to-treat (ITT) Population ........................................................................................ 75 
8.2.2. 
Modified Intent-to-treat (mITT) Population ..................................................................... 76 
8.2.3. 
Per-protocol (PP) Population ............................................................................................ 76 
8.2.4. 
Safety Population (SP) ...................................................................................................... 76 
8.3. 
General Considerations.............................................................................................................. 76 
8.4. 
Handling of Missing Data.......................................................................................................... 76 
8.5. 
Efficacy Analyses ...................................................................................................................... 76 
8.5.1. 
Primary Efficacy Outcome Measure ................................................................................. 76 
8.5.2. 
Secondary Efficacy Outcomes Measures .......................................................................... 77 
8.5.3. 
Adjustment of Multiple Comparisons ............................................................................... 77 
8.6. 
Safety Analyses ......................................................................................................................... 77 
8.7. 
Population Pharmacokinetic Analyses ...................................................................................... 78 
8.8. 
Biomarkers ................................................................................................................................ 78 
8.9. 
Statistical Analysis Plan ............................................................................................................ 78 
8.10. 
Analysis at the End of the Double-blind Treatment Period ....................................................... 78 
8.11. 
Analysis at the End of the Open-label Treatment Period .......................................................... 78 
9. 
References ......................................................................................................................................... 79 
10. 
Appendices .................................................................................................................................... 84 
Appendix 1: 
Schedule of Assessments ............................................................................................... 85 
Appendix 2: 
Adverse Event Definitions and Reporting .................................................................. 93 
Appendix 3: 
Comparison of Systemic Glucocorticoid Preparations .............................................. 97 
Appendix 4: 
Clinical Laboratory Evaluations ................................................................................. 98 
Appendix 5: 
Regulatory, Ethical, and Study Oversight Considerations ....................................... 99 
Appendix 6: 
Liver Safety Suggested Actions and Follow-up Assessments .................................. 103 
Appendix 6.1: Phase II Liver Function Stopping Criteria and Follow-up Assessments ............... 103 
Appendix 6.2: Phase II Liver Function Increased Monitoring Criteria with Continued Therapy. 105 
Appendix 7: 
Oral Corticosteroid Taper .......................................................................................... 106 
Appendix 8: 
Patient Reported Outcomes Assessments ................................................................. 108 
Appendix 8.1: St. George’s Respiratory Questionnaire (SGRQ) .................................................. 108 
Appendix 8.2: Modified King’s Sarcoidosis Questionnaire (mKSQ) ........................................... 114 
Appendix 8.3: Subject Global Assessment (SGA) ........................................................................ 118 
Appendix 8.4: Leicester Cough Questionnaire (LCQ) .................................................................. 119 
Appendix 8.5: Bothersomeness and Subject Global Impression of Change (BSGIC).................. 123 
Appendix 9: 
Clinician Reported Outcome ...................................................................................... 125 
Appendix 9.1: Extrapulmonary Physician Organ Severity Tool (EPOST) ................................... 125 
Appendix 10: 
The Medical Research Council Breathlessness Scale .............................................. 126 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 8 
LIST OF TABLES 
Table 1. 
Identified and Potential Risks................................................................................. 32 
Table 2. 
Discontinuation Criteria for Subjects with Underlying Bundle Branch Block ............... 50 
Table 3. 
Description of Study Treatments ............................................................................ 53 
Table 4. 
Estimated Blood Sample Requirements Per Subject for Subjects who Participate 
in the Double-blind Treatment Period Only ............................................................. 70 
Table 5. 
Estimated Blood Sample Requirements Per Subject for Subjects who Participate 
in Both the Double-blind and OLE Treatment Periods .............................................. 71 
Table 6. 
Sample Size Per Arm Under Different Scenarios ...................................................... 75 
Table 7. 
Corticosteroid Taper Schedule Double-Blind Period ............................................... 106 
Table 8. 
Corticosteroid Taper Schedule Open-Label Extension Period................................... 107 
 
LIST OF FIGURES 
Figure 1. 
Study Design ....................................................................................................... 37 
Figure 2. 
Liver Injury Stopping Criteria ................................................................................ 50 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 9 
PROTOCOL SYNOPSIS 
Title of Study 
A Randomized, Double-blind, Placebo-controlled Phase 2 Study with 
Open-label Extension to Assess the Efficacy and Safety of Namilumab in 
Subjects with Chronic Pulmonary Sarcoidosis 
Indication 
Treatment of chronic pulmonary sarcoidosis (CPS) 
Study Centers 
Approximately 50 sites globally 
Study Objective(s) 
Primary Objective: 
The primary objective of this study is: 
• 
To evaluate the effect of namilumab on the need for rescue treatment 
for worsening of sarcoidosis.  
The secondary objectives of this study are: 
• 
To evaluate the effect of namilumab on percent predicted forced vital 
capacity (ppFVC); 
• 
To evaluate the effect of namilumab on the time to the first rescue 
event; 
• 
To evaluate the effect of namilumab on proportion of subjects 
achieving OCS taper without rescue event; 
• 
To assess the effect of namilumab on respiratory symptoms based on 
the King’s Sarcoidosis Questionnaire (KSQ) Lung domain; 
• 
To assess the safety and tolerability of namilumab. 
The exploratory objectives of this study are: 
• 
To assess the effect of namilumab on other measures of pulmonary 
function; 
• 
To assess the effect of namilumab on the following Patient Reported 
Outcomes (PROs): 
o St. George’s Respiratory Questionnaire (SGRQ); 
o KSQ domains  (including ad-hoc subscales); 
o Modified King’s Sarcoidosis Questionnaire (mKSQ) Lung 
domain;  
o Subject Global Assessment (SGA); 
o Leicester Cough Questionnaire (LCQ); 
o Bothersomeness and Subject Global Impression of Change 
(BSGIC). 
• 
To assess the effect of namilumab on cumulative OCS use and other 
OCS use-related endpoints; 
• 
To evaluate clinical benefit of namilumab 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 10 
• 
To assess the effect of namilumab on the severity of extrapulmonary 
organ involvement; 
• 
To assess the population pharmacokinetics (PPK) and 
exposure-response (E-R) relationships for efficacy and safety of 
namilumab; 
• 
To assess the presence of anti-drug antibody (ADA); 
• 
To assess the effect of namilumab on circulating biomarkers, and the 
correlations between biomarker and clinical endpoint changes. 
 
Study Rationale 
Sarcoidosis is a multi-organ inflammatory disease characterized by non-
necrotizing granulomas believed to be formed from an exaggerated immune 
response to unidentified antigens. Granulomas are tight clusters of 
monocytes/macrophages and multinucleated giant cells (MGCs) interspersed 
with CD4+ T cells. About 90% of the total sarcoidosis population exhibits 
pulmonary involvement. 
Granulocyte-macrophage colony-stimulating factor (GM-CSF), a 
proinflammatory cytokine and myeloid cell growth factor, is thought to play a 
key role in the granulomatous response by stimulating the fusion of 
macrophages into MGCs, activating the mobilization of macrophage 
precursors into tissues, and supporting the crosstalk between CD4+ T cells 
and myeloid cells. Successful late-phase clinical trials of anti-GM-CSF 
monoclonal antibodies in rheumatoid arthritis, giant cell arteritis, and severe 
coronavirus disease 2019 (COVID-19) have provided evidence for the 
pathogenic role of GM-CSF in aberrant immune responses. Over the past 
30 years, human tissue and mouse model studies have shown that GM-CSF 
plays a key role in the formation of granulomas, including sarcoid 
granulomas. Namilumab, a monoclonal antibody (mAb) that neutralizes 
GM-CSF, has the potential to improve outcomes in CPS by downregulating 
the granulomatous response that drives the disease. 
Study Population 
This study will include subjects with CPS who are not well controlled on OCS 
and/or immunosuppressive therapy (IST). The study population will include 
subjects who have been treated with, but are no longer receiving, OCS and/or 
IST. 
Number of Planned 
Subjects 
Approximately 100 subjects (50 subjects in each of 2 treatment arms, 
randomized 1:1 namilumab: placebo) are planned for this study. 
Note: Randomization will be stratified by IST use at baseline. 
Study Design 
Randomized, double-blind, placebo-controlled, with an optional open-label 
extension (OLE). 
Study Treatments 
Double-blind Treatment Period: 
• 
Treatment Arm 1: namilumab administered subcutaneously (SC): 
150 mg on Day 1, Day 15 (Week 2), and then every 4 weeks (Q4W) 
thereafter through Week 22. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 11 
• 
Treatment Arm 2: Placebo administered to match namilumab dosing. 
Open-label Extension (OLE) Treatment Period: 
All subjects, regardless of treatment assignment in the Double-blind 
Treatment Period, who agree and are eligible to participate in the OLE will 
receive namilumab administered SC: 150 mg at Week 26, and then Q4W 
through Week 50. 
Treatment and 
Study Duration 
For subjects who only participate in the Double-blind Treatment Period the 
duration will be approximately 46 weeks as follows: 
• 
Up to 6-week Screening Period; 
• 
26-week Double-blind Treatment Period; 
• 
14-week off-drug Follow-up Period. 
Note: Beginning at the Randomization Visit, each subject taking OCS will 
perform an OCS tapering protocol. Each subject will also stop all ISTs at 
randomization. 
For subjects who complete the Double-blind Treatment Period and continue 
in the OLE, participation will be approximately 74 weeks as follows: 
• 
Up to 6-week Screening Period; 
• 
26-week Double-blind Treatment Period; 
• 
28-week OLE Treatment Period; 
• 
14-week off-drug Follow-up Period. 
Study Endpoint(s) 
The primary endpoint of this study is: 
• 
Proportion of subjects with a rescue event during the DB period 
The secondary endpoints of this study are: 
• 
Change from baseline in percent predicted forced vital capacity 
(ppFVC) at Week 26;  
• 
Time to the first rescue event during DB period; 
• 
Proportion of subjects successfully achieving OCS taper without 
rescue event during DB period; 
• 
Change from baseline in the KSQ Lung domain score at Week 26; 
• 
Safety and tolerability, including assessment of physical examinations 
(PEs), vital signs, electrocardiograms (ECGs), clinical laboratory 
measurements, and AEs during DB period. 
The exploratory endpoints of this study are: 
• 
Change from baseline and categorical assessments in pulmonary 
function in ppFVC (%),FVC (mL), FEV1 (mL), ppFEV1 (%), 
FEV1/FVC (mL/mL), and percent predicted diffusing capacity of 
lung for carbon monoxide hemoglobin corrected value (ppDLco) at 
Week 26; 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 12 
• 
Change from baseline in the following PRO scores at Week 26: 
o SGRQ; 
o KSQ domains (including ad-hoc subscales); 
o mKSQ Lung domain; 
o SGA; 
o LCQ; 
o BSGIC. 
• 
Cumulative OCS (expressed as prednisone equivalent) use and other 
OCS use related endpoints in the Double-blind Treatment and OLE 
Periods, separately and combined; 
• 
Rate of clinical benefit, defined as achieving at least two of the four 
following criteria (without clinically relevant decline in any of these 
parameters or rescue event) at end of the corresponding period: a) an 
improvement of ≥ 5% points from baseline in ppFVC; b) an 
improvement of ≥ 5% points from baseline in ppDLco; c) KSQ Lung 
domain score improvement of ≥ 4 points, d) successfully achieving 
OCS dose ≤ 5 mg/day and at least 5 mg decreased from baseline OCS 
dosing during the corresponding period for subjects who had OCS 
> 5 mg/day at baseline, or achieving OCS free at the end of the 
corresponding period for subjects who had OCS ≤ 5 mg/day at 
baseline during DB period 
• 
Change in extrapulmonary Physician Organ Severity Tool (ePOST) 
score at Week 26; 
• 
PPK and E-R relationship assessments for efficacy and safety, where 
data permit; 
• 
Number of subjects positive for ADA to namilumab during DB 
period; 
• 
Change and percent change from baseline in pre-specified exploratory 
biomarkers and the correlations between biomarker and clinical 
endpoint changes at Week 26. 
To assess the durability of efficacy and safety, all the endpoints will 
also be analyzed for the OLE period for all subjects. 
Inclusion Criteria 
An individual will be eligible for participation in this study only if all of 
the following inclusion criteria are met: 
1. Male or female subjects age ≥ 18 years. 
2. Able and willing to provide written informed consent, which includes 
compliance with study requirements, study procedures (including 
performing acceptable spirometry according to ATS criteria), and 
restrictions listed in the consent form. 
3. ≥ 6-month history of documented sarcoidosis (must include 
histological report, from any organ, in the subject’s medical records). 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 13 
4. Have HRCT scan at screening consistent with pulmonary sarcoidosis 
of the lung parenchyma by central read. 
Note: An HRCT performed as part of clinical care may be used as the 
screening HRCT as long as the HRCT is performed within 4 weeks of 
the Screening Visit and is uploaded and deemed of acceptable quality 
by the imaging vendor/central reader. If not of acceptable quality for 
study inclusion, it needs to be obtained again as part of the study 
inclusion procedures. 
5. ppFVC ≥ 50% and ppDLco (hemoglobin corrected value) ≥ 40% 
predicted at screening. 
6. If receiving prednisone (or equivalent), dose must be ≤ 25 mg, and 
dose must have been stable for at least 4 weeks prior to screening. In 
addition, subject must agree to taper their steroids beginning at the 
time of randomization. 
7. If receiving methotrexate and/or other IST, subject must agree to 
cessation of their IST therapy at randomization. 
8. Have additional evidence of active pulmonary sarcoidosis as defined 
by:  
a. Medical Research Council Dyspnea scale > 1 (i.e., Grade 2 or 
more) at screening; AND 
b. Currently on a treatment regimen for pulmonary sarcoidosis that 
includes OCS, IST, or the combination of OCS and IST. If not 
currently being treated with either OCS or IST, subjects can still 
be eligible if there is documentation in the medical records that 
they have taken OCS and/or IST in the past 2 years for their 
pulmonary sarcoidosis and have been unable to tolerate them, 
treatment was not effective, or they subsequently refused to 
continue taking these medications; AND 
c. One or more of the following is present: 
i. 
Screening FDG-PET scan showing pulmonary 
parenchymal uptake consistent with active pulmonary 
sarcoidosis AND with pulmonary parenchymal SUVmax 
≥ 3 on central read; 
Note: A PET/CT performed as part of clinical care may be 
used as the screening PET/CT as long as the PET/CT is 
performed within 4 weeks of the Screening Visit and is 
uploaded and deemed of acceptable quality by the imaging 
vendor/central reader. If not of acceptable quality for study 
inclusion, it needs to be obtained again as part of the study 
inclusion procedures. 
ii. 
Documentation in the subject’s medical record of 
worsening sarcoidosis (i.e., a clinically meaningful 
worsening in pulmonary function parameters 
(e.g., ≥ 5 percent decline in ppFVC) or clinically relevant 
worsening of radiographic findings (e.g., HRCT, chest 
x-ray) in the past 12 months); 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 14 
iii. 
Documentation in the subject’s medical record that 
tapering OCS (≥ 5 mg change) and/or tapering ISTs 
during the past 12 months resulted in an increase of 
pulmonary disease symptoms, signs, or activity 
necessitating maintenance or increase in dose of OCS 
and/or IST. 
9. Female subjects must agree to use an approved highly effective birth 
control (BC) method (< 1% failure rate per year) for at least 4 weeks 
prior to randomization, throughout the study, and for 18 weeks 
following the last dose of study drug, unless documented to have a 
reproductive status of non-childbearing potential or is 
postmenopausal as defined below: 
a. Non-childbearing potential defined as pre-menopausal female 
with medical history of total hysterectomy, bilateral 
oophorectomy (removal of ovaries), bilateral salpingectomy, 
bilateral tubal ligation, or bilateral hysteroscopic sterilization at 
least 3 months prior to screening; 
b. Postmenopausal defined as 12 months of spontaneous 
amenorrhea without an alternative medical cause.   
10. Male subjects must agree to use condoms when having sexual 
intercourse with female partners of childbearing potential and attest 
that female partners of childbearing potential will use a highly 
effective method of contraception as described above for at least 
4 weeks prior to randomization/enrollment, throughout the study and 
for 18 weeks following the last dose of study drug. Male subjects 
must also agree to not donate sperm from the time of signing consent 
until 18 weeks following the last dose of study drug. 
11. Body Mass Index (BMI) ≤ 40 kg/m2 at screening. 
12. Vaccination for COVID-19 with completion of the primary series at 
least 2 weeks prior to randomization. 
Exclusion Criteria 
An individual will not be eligible for participation in this study if any of 
the following exclusion criteria are met prior to randomization: 
1. Hospitalized for any respiratory illness ≤ 30 days prior to or during 
screening. 
2. ≥ 20% fibrosis as indicated on HRCT-scan assessed by central read 
prior to randomization. 
3. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2 
(Modification of Diet in Renal Disease [MDRD] equation) or 
requiring chronic renal replacement therapy. 
4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), 
or alkaline phosphatase (ALP) > 2 × upper limit of normal range 
(ULN), or serum total bilirubin > 1.5 × ULN.  
Note: Subjects with documented history of Gilbert’s syndrome may 
remain eligible if they have a direct bilirubin ≤ ULN). 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 15 
5. Platelet count < 100,000 per mm3. 
6. Hemoglobin ≤ 9.5 g/dL. 
7. Absolute neutrophil count < 1,500 per mm3. 
8. Corrected serum calcium > 3.0 mmol/L (> 12 mg/dL). 
9. History of pulmonary alveolar proteinosis (PAP). 
10. Use of any prohibited immunomodulator agent, immunoglobulin or 
FcRn inhibitor (approved or investigational) within the 6 months 
prior to or during screening. 
Note: Allergens for hypersensitivity desensitization or vaccines are 
not excluded. EVUSHELD administration for COVID-19 prophylaxis 
is allowed up to within 2 weeks prior to baseline (V2).  
11. Treatment with any Janus kinase (JAK) inhibitor within 6 months 
prior to or during screening. 
12. Participation in another interventional clinical trial within 6 months 
prior to or during screening and throughout the duration of 
participation in this study. 
13. History of left ventricular ejection fraction (LVEF) ≤ 40% or New 
York Heart Association (NYHA) class III or IV heart failure. 
14. ECG abnormalities that warrant further clinical investigation or 
management at screening or Fridericia corrected QT interval (QTcF) 
> 480 msec on the 12-lead ECG at screening; if QTcF exceeds 
480 msec, the ECG should be repeated 2 more times and the average 
of the 3 QTcF measures should be used to determine eligibility. 
Note: If a subject has a pre-existing bundle branch block (BBB), the 
QTcF exclusion cutoff will be > 500 msec. 
15. Pulmonary hypertension requiring therapy. 
16. Systolic blood pressure (SBP) < 90 or > 180 mm Hg; Diastolic blood 
pressure (DBP) < 60 or > 110 mm Hg at screening. 
17. Documented laboratory-confirmed severe acute respiratory syndrome 
coronavirus-2 (SARS-CoV-2) infection with pulmonary involvement 
or signs/symptoms of long COVID as determined by approved testing 
≤ 6 months prior to randomization. 
18. Administration of any fully live virus or bacterial vaccinations within 
3 months prior to or during screening or administration of non-live or 
live-attenuated vaccine within 2 weeks of randomization.  
Note: COVID-19 booster and influenza vaccinations are allowed to 
be completed during the study. 
19. Systemic (oral or parenteral) antibiotic or pulse OCS treatment for 
any indication within 6 weeks prior to randomization. 
Note: A systemic (oral or parenteral) antibiotic prescribed for 
infection prophylaxis (i.e., not for treatment of an infection) is 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 16 
allowed as long as it was started at least 6 weeks prior to the Baseline 
Visit AND is not a prohibited medication per protocol. 
20. Three or more lower-respiratory tract infections requiring 
antimicrobial therapy within 12 months prior to screening. 
21. Any history of mycetoma or fungal respiratory infection. 
22. Requirement for supplemental oxygen at rest. 
23. History of or planned solid organ or hematopoietic cell 
transplantation. 
24. Prior or planned pneumonectomy and/or planned lobectomy.  
Note: Lobectomy performed ≥ 12 months prior to randomization is 
allowed. 
25. Smoking or using any form of inhaled tobacco, inhaled nicotine 
(including vaping), or inhaled cannabis preparations within 6 months 
of screening. Subjects are also excluded if they are not likely to 
refrain from these activities throughout the Study Treatment Period 
and 18 weeks following the last dose of study drug. 
26. A diagnosis of, or presentation consistent with, Lofgren’s syndrome. 
27. Other significant pulmonary disease, or conditions that prevent 
subject from performing acceptable spirometry. 
28. Autoimmune disease other than sarcoidosis likely to require treatment 
during the subject’s participation in this study. 
29. Symptoms and/or signs of extra-pulmonary sarcoidosis (e.g., cardiac 
or neurologic sarcoidosis) that require ongoing treatment that would 
interfere with the protocol-specified treatment regimen or confound 
the interpretation of the study data (e.g., tapering of IST and/or OCS). 
Note: Subjects who require topical or intra-ocular therapies for skin 
or ophthalmic sarcoid disease are not excluded.  
30. History of cardiac disease such as: 
a. Cardiac sarcoidosis with history of clinically significant cardiac 
rhythm disturbance such as complete heart block and ventricular 
tachycardia; history of cardiac device (e.g., pacemaker, 
defibrillator) implantation; or planned cardiac device 
implantation; or history of Class III/IV heart failure or an ejection 
fraction ≤ 40%; OR  
b. Significant ischemic heart disease, including myocardial 
infarction within 6 months, unstable angina, or percutaneous 
transluminal coronary angioplasty (PTCA)/stent within 3 months 
prior to screening; or, planned coronary intervention 
(e.g., coronary artery bypass graft [CABG] or PTCA/stent) during 
the subject’s participation in this study. 
31. Known or suspected active, and untreated/inadequately treated or 
latent TB, human immunodeficiency virus (HIV), hepatitis B or C 
infection. Subjects with positive serology for HIV, hepatitis B or C 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 17 
must have an undetectable viral load by real-time polymerase chain 
reaction (RT-PCR) prior to randomization. 
32. Females who are pregnant or breastfeeding or intend to be during the 
study. 
33. Prior history of any malignancy (not including fully resected 
squamous and basal cell carcinoma of the skin, fully resected intra-
epithelial neoplasia, or carcinoma in situ of the cervix) or 
lymphoproliferative disorder within the past 5 years. 
34. History of severe allergic or anaphylactic reactions to therapeutic 
proteins or known sensitivity to study drug or to its inactive 
components. 
35. History of alcohol or drug abuse, in the Investigator’s opinion, unless 
in full remission for greater than 12 months prior to screening. 
36. Any other acute or chronic medical condition, psychiatric condition, 
or laboratory abnormality that, in the judgment of the Investigator or 
Sponsor, may increase the risk associated with study participation or 
investigational product administration, or may interfere with the 
interpretation of study results, and would make the subject 
inappropriate for entry into this study. 
37. Subjects who are treatment naïve (no history of exposure to a 
therapeutic agent used specifically for the treatment of their 
pulmonary sarcoidosis). 
Database Lock 
The database for the Double-blind period will be frozen and an unblinded 
analysis of efficacy and safety will be performed after all subjects have 
completed the Week 26 visit. 
A final database lock will be performed after the last subject, last visit and 
final data will be provided for all analyses.  
 
Statistical Analyses 
Sample Size Determination 
It is planned to randomize approximately 100 subjects in this study (50 
subjects per arm, 45 evaluable subjects per arm assuming a 10% dropout).  
Assuming a placebo rate of 40%, 90 evaluable subjects (45 subjects per arm) 
will provide a power of approximately 80% to detect the 25% treatment 
difference at a 2-sided significance level of 0.10 based on Fisher’s exact test. 
Populations for Analysis 
• 
The Intent-to-Treat (ITT) Population will include all randomized 
subjects. ITT subjects will be analyzed according to their randomized 
treatment. 
• 
The modified ITT (mITT) Population will include all randomized 
subjects who receive any amount of double-blind study treatment. 
The mITT will be analyzed according to the treatment assigned. This 
population will be used for efficacy analyses. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 18 
• 
The Per-Protocol (PP) Population will include all subjects in the 
mITT Population who have no major protocol violations which may 
impact effectiveness of the treatment. The PP Population will be used 
for supplementary analyses of the efficacy measurements. 
• 
The Safety Population (SP) will include all randomized subjects who 
receive any amount of study drug. The SP will be analyzed according 
to the treatment received. This population will be used for safety 
analyses. 
Statistical Methods in General 
All statistical analyses will be conducted using SAS, Version 9.3 or later. 
Demographic and baseline characteristics will be summarized by treatment 
arm. For continuous measures the mean and SD will be summarized. 
Categorical variables will be described by the count and proportion in each 
category. 
Efficacy Analyses 
The primary efficacy endpoint is the proportion of subjects with a rescue 
event during the Double-blind Treatment Period. The primary efficacy 
analysis will be performed using the mITT population. A Cohcran-Mantel-
Haenszel (CMH) test stratified by use of IST at baseline will be used to 
compare the treatment difference. The difference in proportions between 
treatment groups and the confidence interval based on stratified Miettinen-
Nurminen method will be provided. 
The analysis will also be performed using the PP population. Supplementary 
analyses based on multiple imputation and tipping point analysis for subjects 
who prematurely discontinue the study treatment will also be performed. 
Details will be pre-specified in the SAP. 
For secondary efficacy endpoints, binary endpoints will be summarized using 
numbers and frequency. The CMH test, stratified by baseline IST usage, will 
be used for treatment comparison. Difference in proportions between 
treatment groups as well as the confidence interval based on stratified 
Miettinen-Nurminen method will be provided if needed. Continuous 
endpoints will be summarized using descriptive statistics and compared using 
a mixed model for repeated measures analysis with the treatment, visit, IST 
usage at baseline, and the interaction between treatment and visit as factors, 
and the baseline score as a covariate. Time to event endpoints will be 
summarized using Kaplan-Meier estimates. The treatment effects of the time 
to event endpoints will be evaluated using a log rank test stratified by use of 
IST usage at baseline.  
Adjustment of Multiple Comparisons 
There is only one primary hypothesis, and it will be tested at a 2-sided alpha 
of 0.10. 
No adjustments will be made to account for multiplicity for secondary and 
exploratory endpoints. P-values presented for these endpoints will be nominal 
p-values. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 19 
Analysis at the nd of the Double-blind Treatment Period 
After all subjects have completed the Week 26 visit, the database will be 
frozen and an unblinded analysis of efficacy and safety will be performed. 
Analysis at the End of the Open-label Treatment Period  
Unless otherwise specified, descriptive summaries will be provided for data 
collected during the Open-label Period after all subjects complete the Open-
label Period. The details will be described in the statistical analysis plan 
(SAP). 
Handling of Missing Data 
Analysis of the primary endpoint will be performed using a CMH test based 
on collected data. The reasons for premature discontinuation will be 
identified. Sensitivity analysis based on multiple imputation and assumptions 
of missing not at random, including tipping point analysis, for subjects who 
prematurely discontinue study treatment will be performed. Details on 
missing data sensitivity analyses will be pre-specified in the SAP. 
Safety Analyses 
Safety will be assessed based on the SP for AEs, ECGs, laboratory 
parameters, PEs, vital signs, clinical laboratory tests, and the other safety 
assessments. Full details will be described in the SAP. 
Population Pharmacokinetic Analyses 
The PPK and E-R analyses will be performed based on the modeling analysis 
plan (MAP) and reported separately from the final clinical study report. 
Biomarkers:  
The effect of namilumab on circulating biomarkers, and the correlations 
between biomarker and clinical endpoint changes will be performed and 
reported separately from the final clinical study report. 
Statistical Analysis Plan 
A detailed SAP will be submitted as necessary to regulatory agencies prior to 
unblinding for the Week 26 analysis. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 20 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
β-hCG 
beta human chorionic gonadotropin 
ADA 
anti-drug antibody 
AE(s) 
adverse event(s) 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
AST 
aspartate aminotransferase 
ATS 
American Thoracic Society 
AUC 
area under the concentration-time curve 
BC 
birth control 
BMI 
body mass index 
BP 
blood pressure 
BTK 
Bruton’s tyrosine kinase 
BUN 
blood urea nitrogen 
CABG 
coronary artery bypass graft 
CBC 
complete blood count 
Cavg 
average serum concentration over the dosing interval 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
cLDA 
constrained longitudinal data analysis 
Cmax 
maximum observed concentration 
CMH 
Cochran–Mantel–Haenszel 
Cmin 
minimum serum concentration 
COVID-19 
Coronavirus disease 2019 
CRO 
clinical research organization 
CRP 
C-reactive protein 
CT 
computed tomography 
CYP 
cytochrome P450 
DAS 
Disease Activity Score 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 21 
Abbreviation 
Definition 
DBP 
diastolic blood pressure 
DLco 
diffusing capacity of lung for carbon monoxide 
DMARD(s) 
disease-modifying anti-rheumatic drug(s) 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eGFR 
estimated glomerular filtration rate 
EMA 
European Medicines Agency 
EOS 
End-of-Study 
EOT 
End-of-Treatment 
ePOST 
extrapulmonary Physician Organ Severity Tool 
E-R 
exposure-response 
ERS 
European Respiratory Society 
ET 
Early Termination 
FDA 
Food and Drug Administration 
FDG 
fluorodeoxyglucose 
FEV1 
forced expiratory volume in 1 second 
FEV1/FVC 
FEV1/FVC ratio 
FIH 
first-in-human 
FVC 
forced vital capacity 
GCA 
giant cell arthritis 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte colony stimulating factor 
GGT 
gamma-glutamyl transferase 
GM-CSF 
granulocyte-macrophage colony-stimulating factor 
GM-CSFR 
granulocyte-macrophage colony-stimulating factor receptor 
HbA1C 
glycosylated hemoglobin 
HBcAb 
hepatitis B core antibody 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 22 
Abbreviation 
Definition 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HCVAb 
hepatitis C virus antibody 
HDL-C 
high-density lipoprotein cholesterol 
Hep 
hepatitis 
HIV 
human immunodeficiency virus 
HIVAb 
human immunodeficiency virus antibody 
HPLC 
high-performance liquid chromatography 
HRCT 
high-resolution computed tomography 
HRQoL 
health-related quality of life 
hsCRP 
high-sensitivity C-reactive protein 
ICH 
International Conference on Harmonisation 
ICSR 
Individual Case Safety Reports 
IgE 
immunoglobulin E 
IgG1κ 
human immunoglobulin G1 kappa 
IL 
interleukin 
INR 
international normalized ratio 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IST(s) 
immunosuppressive therapy(ies) 
ITT 
Intent-to-Treat 
IVIG 
intravenous immunoglobulin 
JAK 
Janus kinase 
KSQ 
King’s Sarcoidosis Questionnaire 
MAH 
Marketing Authorization Holder 
mKSQ 
modified King’s Sarcoidosis Questionnaire 
mRNA 
messenger ribonucleic acid 
LABA(s) 
long-acting beta agonist(s) 
LAMA(s) 
long-acting muscarinic agonist(s) 
LCQ 
Leicester Cough Questionnaire 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 23 
Abbreviation 
Definition 
LDH 
lactate dehydrogenase 
LDL-C 
low-density lipoprotein cholesterol 
LVEF 
left ventricular ejection fraction 
mAb 
monoclonal antibody 
MAP 
modeling analysis plan 
MCH 
mean corpuscular hemoglobin 
MCHC 
mean corpuscular hemoglobin concentration 
MCV 
mean corpuscular volume 
MDRD 
Modification of Diet in Renal Disease 
MedDRA 
Medical Dictionary for Regulatory Activities 
MGC(s) 
multinucleated-giant cell(s) 
MHP 
mobile health professional 
mITT 
modified Intent-to-Treat 
MMRM 
mixed-effect model for repeated measures 
MRC 
Medical Research Council 
NRP2 
neuropilin 2 
NYHA 
New York Heart Association 
OCS 
oral corticosteroids 
OLE 
open-label extension 
PAP 
pulmonary alveolar proteinosis 
PE 
physical examination 
PET 
positron emission tomography 
PFT(s) 
pulmonary function test(s) 
PK 
pharmacokinetic 
PP 
per-protocol 
ppFVC 
percent predicted forced vital capacity 
ppDLco 
percent predicted diffusing capacity of lung for carbon 
monoxide 
PPK 
population pharmacokinetics 
PRO(s) 
patient-reported outcome(s) 
PTCA 
percutaneous transluminal coronary angioplasty 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 24 
Abbreviation 
Definition 
PV 
pharmacovigilance 
Q4W 
every 4 weeks 
QTcF 
Fridericia corrected QT interval 
RA 
rheumatoid arthritis 
RBC 
red blood count 
RT-PCR 
real time - polymerase chain reaction 
SAA 
serum amyloid A 
SAE(s) 
serious adverse event(s) 
SAP 
statistical analysis plan 
SARS-CoV-2 
serious acute respiratory syndrome Coronavirus-2 
SBP 
systolic blood pressure 
SC 
subcutaneous(ly) 
SD 
standard deviation 
SE 
standard error 
SGA 
Subject Global Assessment of overall disease burden 
SGRQ 
St. George’s Respiratory Questionnaire 
sIL-2R 
soluble interleukin-2 receptor 
SOC 
system organ class 
SP 
safety population 
SP-D 
serum surfactant protein D 
SUSAR 
suspected unexpected serious adverse reaction 
TARC 
thymus activation regulated chemokine 
TB 
tuberculosis 
TC 
total cholesterol 
TEAE(s) 
treatment-emergent adverse event(s) 
Tmax 
time of maximum observed concentration 
TNF 
tumor necrosis factor 
TG(s) 
total triglyceride(s) 
TTCW 
time-to-clinical worsening 
ULN 
upper limit of normal 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 25 
Abbreviation 
Definition 
UN 
unstructured 
VEGF 
vascular endothelial growth factor 
WBC 
white blood count 
WCBP 
woman of childbearing potential 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 26 
1. 
INTRODUCTION 
Namilumab (KIN-1902, IZN-101, MT203, or AMG203) is a human immunoglobulin G1 kappa 
(IgG1κ) monoclonal antibody (mAb) targeting granulocyte-macrophage colony-stimulating 
factor (GM-CSF), with a molecular weight of approximately 146 kDa, which potently and 
specifically neutralizes human and macaque GM-CSF. GM-CSF is thought to be a key activator 
of the innate arm of the immune system and as such is involved in the chronic stages of 
inflammatory and autoimmune diseases. GM-CSF acts as a pro-inflammatory cytokine and is 
aberrantly overproduced in several inflammatory and autoimmune human diseases. 
Sarcoidosis is a highly heterogeneous condition, with effects ranging from chest radiograph 
abnormalities during routine screening of asymptomatic patients to severe chronic disease with 
pulmonary fibrosis. In a large portion of patients, granulomas resolve with or without therapy, 
and half of them experience remission within 2 years of diagnosis (Valeyre, 2014). Respiratory 
failure is the most common cause of death in patients with sarcoidosis, and pulmonary 
hypertension, which occurs in at least 5% of patients, is a serious complication. Oral 
corticosteroids (OCS) are the mainstay of therapy, but chronic patients require long-term dosing, 
which carries significant toxicities (Baughman, 2015; Khan, 2017; Bargagli, 2018; 
Spagnolo, 2018). Second-line antimetabolite and cytotoxic drugs including methotrexate, 
azathioprine, and mycophenolate mofetil (commonly termed DMARDs, or disease-modifying 
anti-rheumatic drugs) are commonly used as immunosuppressive steroid-sparing therapies 
(ISTs). Only about two-thirds of patients are responsive to these therapies, and only 25% of 
patients achieve full weaning off OCS (Crommelin, 2016; Beegle, 2013). For patients who are 
unresponsive or intolerant to DMARDs, third-line therapy consists of anti-tumor necrosis 
(TNF)-α biologic therapy such as infliximab or adalimumab. While widely utilized in 
rheumatoid arthritis (RA) and other autoimmune conditions, these therapies are not approved by 
the Food and Drug Administration (FDA) for the treatment of sarcoidosis and some patients may 
become intolerant or are unresponsive due to formation of anti-treatment neutralizing antibodies, 
supporting the need for new therapies approved for use in this condition. 
1.1. 
Study Rationale 
The purpose of this study is to establish the efficacy and safety of namilumab in subjects who 
have chronic pulmonary sarcoidosis (CPS) who are not well controlled on OCS and/or ISTs. The 
study population includes subjects on treatment, or who have been treated but are no longer 
receiving OCS and/or IST so long as all inclusion and exclusion criteria are otherwise met (see 
Section 4). If successful, the results will inform the design of further clinical trials and 
registration of namilumab. 
1.2. 
Background 
Sarcoidosis is a multi-organ autoimmune disease characterized by the presence of 
non-necrotizing granulomas believed to be formed from an exaggerated immune response to as 
of yet unidentified antigens. Granulomas are tightly clustered formations of 
monocytes/macrophages and multinucleated giant cells (MGCs; fused activated macrophages) 
interspersed with CD4+ T cells. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 27 
During chronic infections like tuberculosis, caseating granulomas develop that wall off necrosis 
from the surrounding tissue. In contrast, sarcoidosis granulomas are typically non-caseating and 
do not contain a necrotic center (Rosen, 2022). The cause of granuloma formation in sarcoidosis 
is unknown but is believed to be driven by a dysregulated response to an unknown antigen that 
triggers both innate and adaptive immune responses. These responses are coordinated through 
the expression of multiple cytokines (e.g., GM-CSF, IFN, IL-6, TNF) and chemokines 
(e.g., CCL3, CCL5, CCL17) (Iannuzzi, 2007; Drent, 2021). 
The clinical course of sarcoidosis is highly heterogeneous, ranging from chest radiograph 
abnormalities during routine screening of asymptomatic patients to severe disease with 
pulmonary fibrosis. Approximately 200,000 individuals are affected with sarcoidosis in the 
United States (Baughman, 2016). About 25% to 33% of patients have persistent granulomas and 
develop chronic progressive disease that significantly impacts their quality of life and causes 
increased morbidity and mortality (Broos, 2018; Spagnolo, 2018). Nearly all (~90%) patients 
experience pulmonary involvement, and respiratory failure is the most common cause of death 
for these patients (Spagnolo, 2018). Oral corticosteroids are the mainstay of therapy, and 
although patients with chronic disease may receive second-line ISTs, only 25% of patients 
achieve full weaning off OCS. Both OCS and ISTs are known to cause significant toxicities, 
including weight gain, osteoporosis, diabetes, hypertension, and opportunistic infections 
(Hu, 2017; Soto-Gomez, 2016; Khan, 2017). Given that no new therapy has been approved for 
sarcoidosis in decades, development of a new safe and effective steroid-sparing agent for this 
disease represents an area of significant unmet medical need. 
GM-CSF, a pro-inflammatory cytokine and myeloid cell growth factor, is thought to play a key 
role in granuloma formation by stimulating activation of tissue-resident macrophages and 
mobilization of monocytes/macrophages from bone marrow to tissue (Iannuzzi, 2007). GM-CSF 
has been shown to be upregulated in lesioned tissues of subjects with many different 
autoimmune diseases, including sarcoidosis granulomas. Inhibition of the GM-CSF pathway via 
neutralizing antibodies has shown beneficial effects in animal models of multiple autoimmune 
conditions (Hamilton, 2020; Lang, 2020; Mehta, 2020). A Phase 2, randomized, 
placebo-controlled trial of an anti-GM-CSF mAb therapy in subjects with asthma demonstrated 
evidence of benefit in pre-specified subgroups, suggesting a role for GM-CSF in lung 
hyperinflammation (Molfino, 2016). More recently, treatment with mAbs against GM-CSF or 
GM-CSF receptor (GM-CSFR) yielded positive results in randomized, placebo-controlled trials 
of subjects with RA (Hamilton, 2020), giant cell arteritis (Cid, 2020), and severe COVID-19 
(Temesgen, 2022; Patel, 2021), solidifying the role of GM-CSF in aberrant immune responses. 
Given the importance of GM-CSF in autoimmunity and macrophage function, it is unsurprising 
that over the past 30 years, several human tissue and mouse model studies have shown that 
GM-CSF plays a key role in the formation of granulomas, including sarcoid granulomas. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 28 
GM-CSF is an important cytokine during 
multiple parts of the granulomatous response, 
including the fusion of macrophages into 
multinucleated giant cells (Lemaire, 1996; 
Okamoto, 2003; Rangel, 2014), as well as the 
cross-talk between CD4+ T cells and myeloid 
cells (Zhang, 2013; Becher, 2016; Dougan, 
2019). When overexpressed in rat lungs via an 
adenovirus, GM-CSF caused aberrant 
granuloma development and pulmonary 
fibrosis (Xing, 1996a; Xing, 1996b). In mice, 
GM-CSF was required for normal 
granulomatous responses against tuberculosis 
(TB) as GM-CSF-/- mice quickly succumbed 
to infection (Gonzalez-Juarrerro, 2005). 
Specific GM-CSF expression in either lung 
epithelial cells or T cells alone partially 
restored control of TB infection in GM-CSF-/- 
mice (Gonzalez-Juarrerro, 2005; 
Rothchild, 2017). 
 
From Iannuzzi, 2007 
Administration of anti-GM-CSF neutralizing antibodies to mice after TB infection worsened 
granuloma integrity, promoted an anti-inflammatory cytokine and macrophage milieu, and 
impaired host bacterial control, leading to weight loss and deterioration (Benmerzoug, 2018). 
Corroborating these findings, Bryson et al demonstrated that GM-CSF is a critical regulator of 
macrophage state during TB infection, whereby GM-CSF blockade made macrophages more 
permissive to TB growth and GM-CSF addition improved mycobacterial control (Bryson, 2019). 
Multiple groups have reported increased levels of GM-CSF in bronchoalveolar lavage fluid, lung 
tissue, eye fluid, and serum of sarcoidosis subjects, when compared to healthy controls 
(Hoshino, 1995; Ishioka, 1996; Prior, 1996; Crouser, 2009; Patterson, 2013; 
Abu El-Asrar, 2020). Inconsistent with these data, one study demonstrated no difference between 
serum GM-CSF in sarcoidosis subjects versus controls, whereas serum GM-CSF was elevated in 
idiopathic pulmonary fibrosis subjects (Ziora, 2015). Nevertheless, GM-CSF messenger 
ribonucleic acid (mRNA) levels in alveolar fluid of sarcoidosis subjects correlated with clinical 
severity (Itoh, 1990; Itoh, 1993), and alveolar macrophages within lesions of sarcoid subjects 
were shown to have increased GM-CSF secretion (Enthammer, 1993; Itoh, 1998; 
Oltmanns, 2003). In an in vitro model derived from peripheral blood mononuclear cells of 
sarcoidosis subjects, GM-CSF was up-regulated during the formation of pathogenic granulomas 
(Crouser, 2017). Importantly, given that GM-CSF deficiency leads to pulmonary alveolar 
proteinosis (PAP), GM-CSF plays a particularly critical role in the maintenance and action of 
alveolar macrophages, which are known effector cells in sarcoid granuloma formation 
(Silva, 2013). 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 29 
Taken together, GM-CSF is a key regulator of granulomatous responses, and significant 
evidence suggests that GM-CSF may drive sarcoid granuloma formation. The mAb namilumab 
neutralizes GM-CSF and has the potential to improve organ function in patients with pulmonary 
sarcoidosis by downregulating the granulomatous response that drives the disease. 
1.3. 
Benefit-Risk Assessment 
The benefit-risk profile of namilumab is considered favorable for the evaluation of its potential 
to improve signs, symptoms, and health-related quality of life (HRQoL) in subjects with CPS in 
this Phase 2 trial. 
GM-CSF is required for the maintenance of alveolar macrophages, which clear pulmonary 
surfactant. High levels of autoantibodies against GM-CSF may cause PAP, a rare lung disease 
characterized by accumulation of surfactant causing impaired gas exchange (Tazawa, 2019). A 
potential risk of GM-CSF inhibition with namilumab is the development of PAP; however, no 
subject has developed PAP in any anti-GM-CSF or anti-GM-CSFR mAb published trial 
(Hamilton, 2020), including a long-term open-label extension (OLE) study with a median 
treatment duration of 2.5 years (Burmester, 2018). It has been hypothesized that PAP can 
develop only from profound and sustained GM-CSF neutralization by polyclonal autoantibodies 
(Lang, 2020). This hypothesis was based on experiments by Piccoli et al., who demonstrated in 
vivo and in vitro that individual antibodies only partially neutralized GM-CSF, while complete 
neutralization of GM- CSF could only be achieved with multiple non-cross-competing antibodies 
(Piccoli, 2015). Encouragingly, Campbell et al. showed that, while therapeutic-level intravenous 
(IV) doses of anti-GM-CSFR mAb affected systemic GM-CSF signaling, this dose level had no 
effect on cellular responses to GM-CSF in the lung, providing an alternative explanation for the 
lack of PAP observed in trials (Campbell, 2016). To date, no events pertaining to PAP have been 
reported in clinical trials with namilumab.  
Because GM-CSF plays an important role in activating the immune system, another risk of 
namilumab administration is the increased chance for opportunistic infection. High titers of 
autoantibodies against GM-CSF have been associated with infection (Rosen, 2013). 
Nevertheless, no anti-GM-CSF or anti-GM-CSFR trial has reported an increased infection risk 
(Hamilton, 2020). Unlike trials of TNF-targeting agents, no increase in TB has been observed 
despite the role of GM-CSF in granuloma formation and TB protection in mice (Bryson, 2019; 
Hamilton, 2020). This safety profile has been corroborated in recently reported trials of anti-GM-
CSF mAbs for severe hospitalized COVID-19 subjects who were expected to be particularly 
susceptible to opportunistic infection (not yet peer reviewed: Patel, 2021; and peer reviewed: 
Temesgen, 2020; Temesgen, 2022; Criner, 2022). One suspected unexpected serious adverse 
reaction (SUSAR) of bacterial pneumonia was reported in the COVID-19 Investigator-initiated 
study (CATALYST, data not published). In this study additional unrelated cases were reported 
as 2 COVID pneumonitis, 1 pneumonitis and 1 progression of COVID-19 pneumonia. In a Phase 
2b clinical trial with an anti-GM-CSF mAb (GSK 3196165), low rates of serious infections and 
cytopenias were noted, and the adverse event (AE) profile was similar across treatment groups 
(Buckley, 2020). Over 1,000 patients have been administered anti-GM-CSF(R) antibodies in 
clinical trials, with acceptable safety profiles seen to date (Hamilton, 2020). 
Another potential risk is the possibility of decreased neutrophil count/mild neutropenia. In the 
first-in-human (FIH) (M1-1188-001-EM) single dose-escalation study of namilumab in healthy 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 30 
subjects (0.2 mg/kg to 8 mg/kg IV), a decreasing but spontaneously reversible trend of the white 
blood count (WBC) and absolute neutrophil count (ANC) was noticed in some subjects in 
namilumab Groups 4 (3 mg/kg dose level) and 5 (6 mg/kg dose level). The values of WBC and 
ANC were not of clinical concern, and there was no dose-dependent pattern. Two subjects had 
clinically significant low neutrophil values during the study: 1 subject receiving 0.5 mg/kg 
namilumab had a neutrophil count of 1.0×109/L on Day 8 and recovered without treatment by 
Day 15, and another subject receiving 3 mg/kg namilumab had a neutrophil count of 1.1×109/L 
on Day 29 and recovered spontaneously 4 days later. 
In the NEXUS study, ANC and WBC decreases were recorded as drug-related for one subject in 
the namilumab 80 mg treatment group and one subject in the namilumab 150 mg treatment 
group; there were no clinically severe or serious events. 
Neutralization of GM-CSF may potentially cause infection by depression of neutrophil and 
macrophage functions. The incidence of any severe and/or serious infection (with or without 
neutropenia) will be subject to ongoing pharmacovigilance (PV) monitoring in the clinical trial. 
To date, no serious adverse events (SAEs) of decreased neutrophil count or neutropenia have 
been reported with namilumab. 
In the FIH clinical study of namilumab, aspartate aminotransferase/alanine aminotransferase 
(AST/ALT) elevations were seen in isolated subjects. In a small trial in RA (PRIORA), ALT 
and/or AST values above the upper limit of the normal (ULN) range were observed in all 
treatment groups, including 4/9 subjects in the placebo group, 1/8 subjects in the low-dose 
150 mg group, and 3/7 subjects in the high-dose 300 mg dose group. The one patient in the 
low-dose group had measured ALT values > 3 × ULN, meeting the alert threshold value; this 
was reported as an AE. 
In a Phase 2 clinical study in RA (NEXUS), ALT and AST increases were considered drug-
related in one subject in the namilumab 150 mg treatment group.  
In a Phase 2 clinical study in psoriasis (NEPTUNE), 3 subjects in the Double-blind Treatment 
Period and 1 subject in the Follow-up Period experienced elevated AST or ALT but these were 
not considered clinically significant. There were no clinically significant changes in liver enzyme 
parameters throughout the study.  
In the Phase 2 clinical study in axial spondyloarthritis (NAMASTE), 3 non-serious AEs of 
elevated ALT and/or AST were reported in the Double-blind Treatment Period, one of which 
was considered related to the study medication. Cumulatively, there were no SAEs of increased 
AST or ALT reported in the clinical studies with namilumab; nevertheless, AST and ALT levels 
will continue to be monitored in all studies. 
As with any biologic therapy, hypersensitivity reactions are considered a potential risk. Infusion 
reactions may be either type I hypersensitivity reactions (i.e., immunoglobulin IgE-mediated 
allergic reactions) or non-IgE-mediated reactions. To date, there has been no evidence of allergic 
or hypersensitivity reactions to namilumab in any prior clinical trial. Also, the subcutaneous (SC) 
injection may cause administration site pain or inflammation.  
Namilumab has been studied in humans in doses ranging from 0.2 mg/kg to 8 mg/kg in 
Study M1-1188-001-EM (FIM); at 150 mg and 300 mg doses in Study M1-1188-002-EM 
(PRIORA) and Study MT-203-2004 (TELLUS); at 80 mg, 150 mg, and 300 mg in Study 
MT-203/CPH-001; at 20 mg, 80 mg, and 150 mg in Study M1-1188-202 (NEXUS); at 20 mg, 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 31 
50 mg, 80 mg, 150 mg, and 300 mg in Study M1-1188-203 (NEPTUNE); and at 150 mg in 
Study IZN-101 (NAMASTE) and Study KIN-1902-2002 (RESOLVE-Heart). Across 9 
completed studies, a total of 404 subjects or healthy volunteers have been enrolled into the 
clinical development program for namilumab, with 333 subjects estimated to have received 
namilumab. In addition, subjects with COVID-19 were treated with a single dose of 150 mg 
namilumab in an Investigator-initiated trial in the United Kingdom known as the CATALYST 
study (n=55) or Investigator-Sponsored compassionate use study (n=2). Overall namilumab has 
been well tolerated with an acceptable safety profile for further development. 
Based on the known data, the potential benefits of namilumab treatment outweigh the potential 
risks. Preclinical and human-tissue studies have suggested that GM-CSF plays a key role in the 
formation of granulomas, including sarcoid granulomas. Positive clinical trials of anti-GM-CSF 
agents in RA, giant-cell arthritis, and COVID-19 have demonstrated a key role of GM-CSF as a 
driver of autoimmunity and hyperinflammation. The sarcoidosis subjects in this study will have 
chronic and relatively severe disease and may be receiving high doses of OCS or will have failed 
several agents. Current treatment strategies, including long-term use of OCS are associated with 
significant toxicities (Khan, 2017), and other treatment options for these subjects (cytotoxic 
agents and anti-TNF agents) have toxicity concerns of their own (Callejas-Rubio, 2008). 
Given that no new therapy has been approved for sarcoidosis in decades, namilumab may prove 
to be a useful treatment for these chronic progressive subjects with limited options. 
In summary, the anticipated potential risks include the occurrence of adverse reactions 
(i.e., decreased neutrophil count/mild neutropenia, PAP, infection, and/or hypersensitivity 
reactions). No AEs suggestive of PAP, severe hypersensitivity, or severe neutropenia have been 
reported in the namilumab clinical program to date. 
The following have been delineated as identified risks: 
• AST and/or ALT elevation. 
The following have been delineated as potential risks: 
• PAP; 
• Immune and immunomodulatory reactions; 
• Decreased white cell count/neutropenia; 
• Infection; 
• Injection site findings. 
Based on nonclinical studies and the available data from 9 completed clinical studies, the risks 
associated with exposure to namilumab are justified by the anticipated benefits that may be 
afforded. The benefit-risk ratio for namilumab is considered positive for the further study of 
namilumab in subjects with CPS. 
Identified, potential risks, and the planned mitigation strategies are described in Table 1. More 
detailed information about the known and expected benefits and risks, reasonably expected AEs 
associated with namilumab, and mitigation strategies may be found in the Investigator’s 
Brochure. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 32 
Table 1. 
Identified and Potential Risks 
Risk 
Source 
Key Details 
Actions 
AST/ALT elevation 
Nonclinical studies (Single 
dose & repeat dose toxicity 
studies); Clinical Studies 
(FIH, PRIORA, NEXUS, 
NEPTUNE, and 
NAMASTE studies) 
Important identified risk Exclusion criteria; 
routine 
pharmacovigilance (PV) 
monitoring: evaluation 
of Individual Case 
Safety Reports (ICSRs); 
AEs, signal detection, 
and aggregate reports 
Decreased neutrophil 
count/ mild neutropenia 
FIH study and NEXUS 
Study 
Important potential risk Exclusion criteria; 
routine PV monitoring 
PAP 
26-week monkey toxicity 
study; foamy macrophages 
were observed. 
Important potential risk Exclusion criteria; 
targeted/close 
monitoring; Investigator 
Guidance for early 
detection & 
management 
Hypersensitivity 
reactions/allergic 
reactions (IgE- 
mediated; non-IgE- 
mediated) 
Biological nature of 
molecule 
Important potential risk Exclusion criteria; 
routine PV monitoring: 
evaluation of ICSRs, 
AEs, signal detection, 
and aggregate reports 
Infection 
Biological nature of 
molecule; Clinical study 
(CATALYST) 
Important potential risk TB screening, chest 
imaging at baseline, 
exclusion criteria, 
routine PV monitoring: 
evaluation of ICSRs, 
AEs, signal detection, 
and aggregate reports 
AEs = adverse events; AST = aspartate aminotransferase; ALT = alanine aminotransferase; FIH = first-in-human; 
ICSR = Individual Case Safety Reports; PAP = pulmonary alveolar proteinosis; PV = pharmacovigilance; 
TB = tuberculosis. 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 33 
2. 
OBJECTIVES AND ENDPOINTS 
2.1. 
Objectives 
The primary objective of this study is: 
• To evaluate the effect of namilumab on the need for rescue treatment for worsening of 
sarcoidosis.  
The secondary objectives of this study are: 
• To evaluate the effect of namilumab on percent predicted forced vital capacity (ppFVC); 
• To evaluate the effect of namilumab on the time to the first rescue event; 
• To evaluate the effect of namilumab on proportion of subjects achieving OCS taper 
without rescue event; 
• To assess the effect of namilumab on respiratory symptoms based on the King’s 
Sarcoidosis Questionnaire (KSQ) Lung domain; 
• To assess the safety and tolerability of namilumab. 
The exploratory objectives of this study are: 
• To assess the effect of namilumab on other measures of pulmonary function; 
• To assess the effect of namilumab on the following Patient Reported Outcomes (PROs): 
o St. George’s Respiratory Questionnaire (SGRQ); 
o KSQ domains (including ad-hoc subscales); 
o Modified King’s Sarcoidosis Questionnaire (mKSQ) Lung domain 
o Subject Global Assessment (SGA); 
o Leicester Cough Questionnaire (LCQ); 
o Bothersomeness and Subject Global Impression of Change (BSGIC). 
• To assess the effect of namilumab on cumulative OCS use and other OCS use-related 
endpoints; 
• To evaluate clinical benefit of namilumab; 
• To assess the effect of namilumab on the severity of extrapulmonary organ involvement; 
• To assess the population pharmacokinetics (PPK) and exposure-response (E-R) 
relationships for efficacy and safety of namilumab; 
• To assess the presence of anti-drug antibody (ADA); 
• To assess the effect of namilumab on circulating biomarkers, and the correlations 
between biomarker and clinical endpoint changes. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 34 
2.2. 
Endpoints 
The primary endpoint of this study is: 
• Proportion of subjects with a rescue event during the DB period 
The secondary endpoints of this study are: 
• Change from baseline in percent predicted forced vital capacity (ppFVC) at Week 26; 
• Time to first rescue event during DB period; 
• Proportion of subjects successfully achieving OCS taper without rescue event during DB 
period; 
• Change from baseline in the KSQ Lung domain score at Week 26; 
• Safety and tolerability, including assessment of physical examinations (PEs), vital signs, 
electrocardiograms (ECGs), clinical laboratory measurements, and AEs during DB 
period. 
The exploratory endpoints of this study are: 
• Change from baseline and categorical assessments in pulmonary function in ppFVC (%), 
FVC (mL), FEV1 (mL), ppFEV1 (%), FEV1/FVC (mL/mL), and ppDLco at Week 26; 
• Change from baseline in the following PRO scores at Week 26: 
o SGRQ; 
o KSQ domains (including ad-hoc subscales); 
o mKSQ Lung domain; 
o SGA; 
o LCQ; 
o BSGIC. 
• Cumulative OCS (expressed as prednisone equivalent) use and other OCS use related  
endpoints in the DB and OLE Periods, separately and combined; 
• Rate of clinical benefit, defined as achieving at least two of the four following criteria 
(without clinically relevant decline in any of these parameters or rescue event) at end of 
the corresponding period: a) an improvement of ≥ 5% points from baseline in ppFVC; b) 
an improvement of ≥ 5% points from baseline in ppDLco; c) KSQ Lung domain score 
improvement of ≥ 4 points, d) successfully achieving OCS dose ≤ 5 mg/day and at least 
5 mg decreased from baseline OCS dosing during the corresponding period for subjects 
who had OCS > 5 mg/day at baseline, or achieving OCS free at the end of the 
corresponding period for subjects who had OCS ≤ 5 mg/day at baseline during DB period 
• Change in extrapulmonary Physician Organ Severity Tool (ePOST) score at Week 26; 
• PPK and E-R relationship assessments for efficacy and safety during the DB period, 
where data permit; 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 35 
• Number of subjects positive for ADA to namilumab during DB period; 
• Change and percent change from baseline in pre-specified exploratory biomarkers and 
the correlations between biomarker and clinical endpoint changes at Week 26. 
To assess the durability of efficacy and safety, all endpoints will also be analyzed for the OLE 
period. 
3. 
INVESTIGATIONAL PLAN 
3.1. 
Overall Study Design and Plan Description 
This is a Phase 2, randomized, double-blind, placebo-controlled study with an optional 
open-label extension (OLE). 
Approximately 100 subjects (50 subjects in each of 2 treatment arms) will be randomized 1:1 to 
receive study drug or placebo in the Double-blind Treatment Period of the study. The 
randomization will be stratified by IST use at baseline. 
Double-blind Treatment Period: 
• Treatment Arm 1: Study drug administered subcutaneously (SC): 150 mg on Day 1, 
Day 15 (Week 2), and then every 4 weeks (Q4W) thereafter through Week 22; 
• Treatment Arm 2: Placebo administered to match study drug dosing. 
Beginning at the Randomization Visit, each subject taking OCS will perform an OCS tapering 
protocol as outlined in Appendix 7. Each subject will also stop all ISTs at randomization. 
For subjects who only participate in the Double-blind Treatment Period, the duration will be 
approximately 46 weeks as follows: 
• Up to 6-week Screening Period; 
• 26-week Double-blind Treatment Period; 
• 14-week off-drug Follow-up Period (see below). 
Open-label Extension (OLE) Treatment Period: 
All subjects, regardless of treatment assignment in the Double-blind Treatment Period, who 
agree to participate in the OLE will receive study drug administered SC: 150 mg at Week 26 and 
then Q4W through Week 50. 
For subjects who participate in the OLE, the duration will be approximately 42 weeks as follows: 
• Up to 28 weeks OLE Treatment Period 
• 14 weeks off-drug Follow-up Period (see below) 
For subjects who participate in both the Double-blind and OLE Treatment Periods, the duration 
will be approximately 74 weeks as follows: 
• Up to 6-week Screening Period; 
• 26-week Double-blind Treatment Period; 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 36 
• 28-week OLE Treatment Period  
• 14-week off-drug Follow-up Period (see below) 
Follow-up Period:  
Safety follow-up phone call or telemedicine visits will occur approximately 4 weeks and 8 weeks 
following the EOT; a follow-up clinic visit will occur at approximately 14 weeks following the 
EOT.  
The visit at 18 weeks following the last dose of study drug will be considered the End-of-Study 
(EOS) Visit.  
Note: If in the opinion of the Investigator there is a clinically relevant safety concern during the 
Follow-up Period, the Investigator will bring the subject into the clinic for an unscheduled visit. 
After End-of-Study (EOS) Visit, subjects may resume Standard of Care (SOC) treatment. The 
study design is presented in Figure 1a for subjects who participate in only the Double-blind 
Treatment Period and Figure 1b for subjects who participate in both the Double Blind and OLE 
Treatment Periods. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 37 
Figure 1. 
Study Design 
a. Subjects who Participate in Only the Double-blind Treatment Period  
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 38 
b. Subjects who Participate in Both the Double-blind and Open-label Extension Treatment Periods 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 39 
3.1.1. 
Screening Period 
Written informed consent will be obtained from all subjects prior to beginning any study-related 
procedures. The collection of SAEs will begin after the subject has signed the informed consent 
form (ICF). The Screening Period is up to 6 weeks; however, subjects may be randomized as 
soon as they are deemed eligible as long as they continue to meet eligibility criteria. During the 
Screening Period, doses of OCS should remain unchanged. If there is a change in OCS, the 
subject should be screen failed. 
3.1.2. 
26-Week Double-blind Treatment Period 
Subjects will begin the 26-week Double-blind Treatment Period after confirmation that all 
protocol eligibility criteria have been met. 
Some visits in the Double-blind Treatment Period will be required to be conducted in the clinic, 
some may be conducted either at the clinic or at the subject’s home (in applicable countries) with 
a Sponsor-approved home healthcare professional, and some will be conducted via phone or 
telemedicine, per the Schedule of Assessments (SOA) (Appendix 1). 
Subjects receiving OCS at the time of randomization will begin tapering their OCS as described 
in Appendix 7. During the steroid taper period, Investigators will contact subjects weekly via 
phone or telemedicine visits as outlined in Appendix 1. In addition, subjects must cease any IST 
at the time of randomization prior to the first dose of study drug. 
Prior to completing the Week 26 End-of-Treatment/Early Termination (EOT/ET) visit, 
Investigators should confirm whether the subject is eligible and willing to participate in the OLE 
Period. If the subject is eligible and willing to participate in the OLE Period, they will complete 
the Week 26 visit on the Schedule of Assessments for the OLE Period and will not move into the 
Follow-up Period until they have completed the OLE or have discontinued study drug 
permanently. See the SOA for all assessments required for each visit (Appendix 1). 
If a subject needs to discontinue study drug (temporarily or permanently) or terminate study 
participation before completion of the Double-blind Treatment Period, please refer to 
Section 4.4.2.3 for detailed instructions regarding recommended follow-up. 
3.1.3. 
Open-label Extension Period 
The purpose of the 28-week OLE Period is to provide additional data on the benefit-risk of study 
drug over a treatment period of up to 54 weeks, and to assess the durability of efficacy in 
subjects treated with study drug. Further, the OLE will allow for an assessment of the efficacy of 
study drug in subjects who initially received placebo. 
The OLE Period is optional; subjects will be eligible for the OLE if: a) they have completed their 
treatment through Week 22 of the Double-blind Treatment Period, and b) sign the informed 
consent addendum for the OLE. All subjects who choose to participate in the OLE Period will 
receive study drug regardless of treatment assignment during the Double-blind Treatment Period. 
As with the Double-blind Treatment Period, some visits of the OLE will be required to be 
conducted in the clinic, some visits may be conducted either at the clinic or at the subject’s home 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 40 
(in applicable countries) with a Sponsor-approved home healthcare professional, and some visits 
will be conducted via phone or telemedicine, per the SOA (Appendix 1). 
All subjects in the OLE Period will be treated with open-label study drug and should also 
continue to take any OCS or allowed ISTs that they are taking which may have been added as 
rescue treatment during the Double-blind Treatment Period. Starting at Week 30, efforts should 
be made to taper/remove OCS and ISTs as described in Appendix 7. If a subject discontinues 
study drug (temporarily or permanently) or terminates study participation before completion of 
the OLE Period, please refer to Section 4.4.2.3 for detailed instructions regarding recommended 
follow-up. 
3.1.4. 
Follow-up Period 
All subjects, regardless of when they complete their last dose of study drug, will have 
3 follow-up visits following the End-of-Treatment Visit to obtain information on safety 
laboratories, concomitant medication use, SAEs, and any AEs that were ongoing at the time of 
the EOT/ET Visit.  
End of Treatment (EOT)/Early termination (ET) will occur approximately 4 weeks following last 
dose of study drug. 
Phone call or telemedicine visits will occur approximately 8 weeks and 12 weeks following the 
last dose of study drug; a follow-up clinic visit will occur approximately 18 weeks following the 
last dose of study drug. See the SOA (Appendix 1) for details on what assessments are required.  
For phone or telemedicine visits, female subjects will be required to complete a home urine 
pregnancy test and report the result to the Investigator at the time of the phone call/telemedicine 
visit. If a positive result is obtained, the Investigator will schedule an on-site visit at the clinic for 
a confirmatory serum pregnancy test. In addition, if any other clinically relevant safety concern 
is identified during one of these visits, the Investigator will schedule an unscheduled clinic visit 
to complete any necessary safety assessments. 
3.1.5. 
Unscheduled Visits 
During the study, additional contact by phone call(s), or unscheduled site visit(s) (or both), may 
be considered, based on the Investigator’s discretion. Assessments completed during these visits 
(in clinic or by phone call), may include evaluation of any AEs or SAEs the subject is 
experiencing. The unscheduled visit electronic case report form (eCRF) will be completed for 
each unscheduled phone contact or site visit. If an unscheduled visit occurs due to the need for 
rescue treatment the Investigator should follow the instructions in Section 3.1.5.1 prior to 
commencing rescue treatment. 
3.1.5.1. 
Rescue Visit 
A Rescue Visit is an unscheduled visit that must be conducted the first time a subject requires a 
rescue treatment. During the Double-blind and OLE Treatment Periods, if a subject requires, or 
have received, rescue treatment outside of a required study visit the Investigator must schedule a 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 41 
Rescue Visit to confirm the need for rescue treatment for worsening sarcoidosis (see 
Section 6.4).  
A Rescue Visit may only be scheduled one time during the Double-blind and one time in the 
OLE Period of the study, even though unscheduled visits and/or changes in medicines may occur 
after a Rescue Visit.  
Prior to providing rescue treatment (Section 6.4), every effort should be made to complete all 
assessments specified for the week 26 clinic visit as outlined in Appendix 1. Thereafter the 
subject should complete the visits per protocol (Appendix 1).  
The Rescue Visit should be documented on the appropriate eCRF page, including the medical 
reason for rescue treatment. If subject requires rescue treatment for the signs/symptoms of 
worsening sarcoidosis, investigators must document worsening sarcoidosis on the AE eCRF. 
Changes in medications should be recorded on the concomitant medication page of the eCRF. 
At the Rescue Visit, the Investigator should adjust medications to achieve clinical stability. An 
unscheduled visit may be added for subsequent alterations of medications for worsening 
sarcoidosis in the Double-blind and OLE Treatment Periods. 
3.2. 
Discussion of Study Design, Including the Choice of Control Group 
A robust, double-blind, randomized, placebo-controlled design has been selected. Such a design 
will provide evidence concerning the use of GM-CSF inhibition for the treatment of pulmonary 
sarcoidosis. Subjects in the study will have a relatively severe and chronic phenotype, having 
been not well controlled or failed on first line and second-line therapies. Given the limited 
natural history data on these subjects and the highly heterogeneous nature of sarcoidosis, a 
blinded placebo control is critical to ensure that the study is as generalizable and as unbiased as 
possible. It is not known how study drug or placebo, along with tapering of OCS and/or removal 
of IST, will affect outcomes and quality of life for these subjects. 
3.3. 
End of Study Definition 
The visit 18 weeks following the last dose of study drug will be considered the End-of-Study 
(EOS) Visit. 
The end of the study is defined as the date of the last visit of the last subject in the study.  
3.4. 
Selection of Doses in the Study 
Study drug 150 mg SC on Days 1 and 15 followed by every 4 weeks (Q4W) through Week 22 is 
considered likely to be efficacious for subjects with sarcoidosis based on previous experience. 
With comparable dosing regimens in other indications such as RA a dose-related improvement in 
the Disease Activity Score 28-joint count (DAS-28) C-reactive protein (CRP) was observed 
reaching significance with the 150 mg dose, but not with lower doses. Efficacy with the 150 mg 
dose was like that observed with other biologics approved in RA. At this dosing regimen, the 
PPK model-projected AUC0-672h at steady state is 415 μg•day/mL, which is under the FDA 
capped AUC0-672h of 690 μg•day/mL, as per discussions with the FDA. A 26-week Treatment 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 42 
Period is considered the minimum duration to fully understand the kinetics of the efficacy 
response to study drug in the CPS sarcoidosis population. Furthermore, the OLE with a treatment 
period up to Week 54 will provide additional safety and efficacy information and will provide 
the opportunity for study subjects to receive study drug for an extended duration (and placebo 
subjects to cross over). There are currently no known biomarkers for sarcoidosis and a lower 
dose may be sub-optimal for efficacy. 
4. 
SELECTION OF SUBJECT POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
4.1. 
Inclusion Criteria 
An individual will be eligible for participation in this study only if all of the following 
inclusion criteria are met: 
1. Male or female subjects age ≥ 18 years. 
2. Able and willing to provide written informed consent, which includes compliance with 
study requirements, study procedures (including performing acceptable spirometry 
according to ATS criteria), and restrictions listed in the consent form. 
3. ≥ 6-month history of documented sarcoidosis (must include histological report, from any 
organ, in the subject’s medical records). 
4. Have HRCT scan at screening consistent with pulmonary sarcoidosis of the lung 
parenchyma by central read. 
Note: An HRCT performed as part of clinical care may be used as the screening HRCT 
as long as the HRCT is performed within 4 weeks of the Screening Visit and is uploaded 
and deemed of acceptable quality by the imaging vendor/central reader. If not of 
acceptable quality for study inclusion, it needs to be obtained again as part of the study 
inclusion procedures. 
5. ppFVC ≥ 50% and ppDLco (hemoglobin corrected value) ≥ 40% predicted at screening. 
6. If receiving prednisone (or equivalent), dose must be ≤ 25 mg, and dose must have been 
stable for at least 4 weeks prior to screening. In addition, subject must agree to taper their 
steroids beginning at the time of randomization. 
7. If receiving methotrexate and/or other IST, subject must agree to cessation of their IST 
therapy at randomization. 
8. Have additional evidence of active pulmonary sarcoidosis as defined by:  
a. Medical Research Council Dyspnea scale > 1 (i.e., Grade 2 or more) at screening 
(Appendix 10); AND 
b. Currently on a treatment regimen for pulmonary sarcoidosis that includes OCS, IST, 
or the combination of OCS and IST. If not currently being treated with either OCS or 
IST, subjects can still be eligible if there is documentation in the medical records that 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 43 
they have taken OCS and/or IST in the past 2 years for their pulmonary sarcoidosis 
and have been unable to tolerate them, treatment was not effective, or they 
subsequently refused to continue taking these medications; AND 
c. One or more of the following is present: 
i. 
Screening FDG-PET scan showing pulmonary parenchymal uptake consistent 
with active pulmonary sarcoidosis AND with pulmonary parenchymal 
SUVmax ≥ 3 on central read; 
Note: A PET/CT performed as part of clinical care may be used as the 
screening PET/CT as long as the PET/CT is performed within 4 weeks of the 
Screening Visit and is uploaded and deemed of acceptable quality by the 
imaging vendor/central reader. If not of acceptable quality for study inclusion, 
it needs to be obtained again as part of the study inclusion procedures. 
ii. 
Documentation in the subject’s medical record of worsening sarcoidosis 
(i.e., a clinically meaningful worsening in pulmonary function parameters 
(e.g., ≥ 5 percent decline in ppFVC) or clinically relevant worsening of 
radiographic findings (e.g., HRCT, chest x-ray) in the past 12 months);   
iii. 
Documentation in the subject’s medical record that tapering OCS (≥ 5 mg 
change) and/or tapering ISTs during the past 12 months resulted in an increase 
of pulmonary disease symptoms, signs, or activity necessitating maintenance 
or increase in dose of OCS and/or IST. 
9. Female subjects must agree to use an approved highly effective birth control (BC) 
method (< 1% failure rate per year) for at least 4 weeks prior to randomization, 
throughout the study, and for 18 weeks following the last dose of study drug 
(Section 6.3), unless documented to have a reproductive status of non-childbearing 
potential or is postmenopausal as defined below: 
a. Non-childbearing potential defined as pre-menopausal female with medical history of 
total hysterectomy, bilateral oophorectomy (removal of ovaries), bilateral 
salpingectomy, bilateral tubal ligation, or bilateral hysteroscopic sterilization at least 
3 months prior to screening; 
b. Postmenopausal defined as 12 months of spontaneous amenorrhea without an 
alternative medical cause. 
10. Male subjects must agree to use condoms when having sexual intercourse with female 
partners of childbearing potential and attest that female partners of childbearing potential 
will use a highly effective method of contraception as described above for at least 
4 weeks prior to randomization/enrollment, throughout the study and for 18 weeks 
following the last dose of study drug. Male subjects must also agree to not donate sperm 
from the time of signing consent until 18 weeks following the last dose of study drug. 
11. Body Mass Index (BMI) ≤ 40 kg/m2 at screening 
12. Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior 
to randomization. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 44 
4.2. 
Exclusion Criteria 
An individual will not be eligible for participation in this study if any of the following 
exclusion criteria are met prior to randomization: 
1. Hospitalized for any respiratory illness ≤ 30 days prior to or during screening. 
2. ≥ 20% fibrosis as indicated on HRCT-scan assessed by central read prior to 
randomization. 
3. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2 (Modification of Diet 
in Renal Disease [MDRD] equation) or requiring chronic renal replacement therapy. 
4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline 
phosphatase (ALP) > 2 × upper limit of normal range (ULN), or serum total bilirubin 
> 1.5 × ULN.  
Note: Subjects with documented history of Gilbert’s syndrome may remain eligible if 
they have a direct bilirubin ≤ ULN). 
5. Platelet count < 100,000 per mm3. 
6. Hemoglobin ≤ 9.5 g/dL. 
7. Absolute neutrophil count < 1,500 per mm3. 
8. Corrected serum calcium > 3.0 mmol/L (> 12 mg/dL). 
9. History of pulmonary alveolar proteinosis (PAP). 
10. Use of any prohibited immunomodulator agent, immunoglobulin or FcRn inhibitor 
(approved or investigational) (Section 6.2) within the 6 months prior to or during 
screening. 
Note: Allergens for hypersensitivity desensitization or vaccines are not excluded. 
EVUSHELD administration for COVID-19 prophylaxis is allowed up to within 2 weeks 
prior to baseline (V2).  
11. Treatment with any Janus kinase (JAK) inhibitor within 6 months prior to or during 
screening. 
12. Participation in another interventional clinical trial within 6 months prior to or during 
screening and throughout the duration of participation in this study. 
13. History of left ventricular ejection fraction (LVEF) ≤ 40% or New York Heart 
Association (NYHA) class III or IV heart failure. 
14. ECG abnormalities that warrant further clinical investigation or management at screening 
or Fridericia corrected QT interval (QTcF) > 480 msec on the 12-lead ECG at screening; 
if QTcF exceeds 480 msec, the ECG should be repeated 2 more times and the average of 
the 3 QTcF measures should be used to determine eligibility. 
Note: If a subject has a pre-existing bundle branch block (BBB), the QTcF exclusion 
cutoff will be > 500 msec. 
15. Pulmonary hypertension requiring therapy. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 45 
16. Systolic blood pressure (SBP) < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) 
< 60 or > 110 mm Hg at screening. 
17. Documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 
(SARS-CoV-2) infection with pulmonary involvement or signs/symptoms of long 
COVID as determined by approved testing ≤ 6 months prior to randomization. 
18. Administration of any fully live virus or bacterial vaccinations within 3 months prior to 
or during screening or administration of non-live or live-attenuated vaccine within 2 
weeks of randomization.  
Note: COVID-19 booster and influenza vaccinations are allowed to be completed during 
the study. 
19. Systemic (oral or parenteral) antibiotic or pulse OCS treatment for any indication within 
6 weeks prior to randomization. 
Note: A systemic (oral or parenteral) antibiotic prescribed for infection prophylaxis 
(i.e., not for treatment of an infection) is allowed as long as it was started at least 6 weeks 
prior to the Baseline Visit AND is not a prohibited medication per protocol. 
20. Three or more lower-respiratory tract infections requiring antimicrobial therapy within 
12 months prior to screening. 
21. Any history of mycetoma or fungal respiratory infection. 
22. Requirement for supplemental oxygen at rest. 
23. History of or planned solid organ or hematopoietic cell transplantation. 
24. Prior or planned pneumonectomy and/or planned lobectomy.  
Note: Lobectomy performed ≥ 12 months prior to randomization is allowed. 
25. Smoking or using any form of inhaled tobacco, inhaled nicotine (including vaping), or 
inhaled cannabis preparations within 6 months of screening. Subjects are also excluded if 
they are not likely to refrain from these activities throughout the Study Treatment Period 
and 18 weeks following the last dose of study drug. 
26. A diagnosis of, or presentation consistent with, Lofgren’s syndrome. 
27. Other significant pulmonary disease, or conditions that prevent subject from performing 
acceptable spirometry. 
28. Autoimmune disease other than sarcoidosis likely to require treatment during the 
subject’s participation in this study. 
29. Symptoms and/or signs of extra-pulmonary sarcoidosis (e.g., cardiac or neurologic 
sarcoidosis) that require ongoing treatment that would interfere with the 
protocol-specified treatment regimen or confound the interpretation of the study data 
(e.g., tapering of IST and/or OCS). 
Note: Subjects who require topical or intra-ocular therapies for skin or ophthalmic 
sarcoid disease are not excluded.  

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 46 
30. History of cardiac disease such as: 
a. Cardiac sarcoidosis with history of clinically significant cardiac rhythm disturbance 
such as complete heart block and ventricular tachycardia; history of cardiac device 
(e.g., pacemaker, defibrillator) implantation; or planned cardiac device implantation; 
or history of Class III/IV heart failure or an ejection fraction ≤ 40%; OR  
b. Significant ischemic heart disease, including myocardial infarction within 6 months, 
unstable angina, or percutaneous transluminal coronary angioplasty (PTCA)/stent 
within 3 months prior to screening; or, planned coronary intervention (e.g., coronary 
artery bypass graft [CABG] or PTCA/stent) during the subject’s participation in this 
study. 
31. Known or suspected active, and untreated/inadequately treated or latent TB, human 
immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with positive 
serology for HIV, hepatitis B or C must have an undetectable viral load by real-time 
polymerase chain reaction (RT-PCR) prior to randomization. 
32. Females who are pregnant or breastfeeding or intend to be during the study. 
33. Prior history of any malignancy (not including fully resected squamous and basal cell 
carcinoma of the skin, fully resected intra-epithelial neoplasia, or carcinoma in situ of the 
cervix) or lymphoproliferative disorder within the past 5 years. 
34. History of severe allergic or anaphylactic reactions to therapeutic proteins or known 
sensitivity to study drug or to its inactive components. 
35. History of alcohol or drug abuse, in the Investigator’s opinion, unless in full remission for 
greater than 12 months prior to screening. 
36. Any other acute or chronic medical condition, psychiatric condition, or laboratory 
abnormality that, in the judgment of the Investigator or Sponsor, may increase the risk 
associated with study participation or investigational product administration, or may 
interfere with the interpretation of study results, and would make the subject 
inappropriate for entry into this study. 
37. Subjects who are treatment naïve (no history of exposure to a therapeutic agent used 
specifically for the treatment of their pulmonary sarcoidosis). 
4.3. 
Disease Diagnostic Criteria 
Subjects will require at least a 6-month diagnosis of pulmonary sarcoidosis, with histological 
confirmation of the diagnosis in their medical record. A repeat diagnostic work-up is not 
required. Sufficient documentation of histology includes a histopathological report in the medical 
record. A histopathological report on fine needle aspirate can also serve as sufficient 
documentation. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 47 
4.4. 
Discontinuation Criteria 
4.4.1. 
Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical study but do not 
meet all eligibility criteria and therefore are unable to be randomized into the study. Subjects not 
meeting eligibility criteria because of laboratory result(s), borderline vital sign assessments, or 
time requirements for infection (including COVID-19), smoking, vaccination or prior therapy 
use may have the test(s) repeated once during the Screening Period at the discretion of the 
Investigator to determine eligibility or may be rescreened after the appropriate time has elapsed 
to meet entry criteria. If the 6 weeks of the initial Screening Period has elapsed before eligibility 
can be ascertained, subjects may repeat all screening requirements after reconsenting. No one 
subject may be screened more than twice for inclusion in the trial. 
If the reason for screen failure is related to the central read of the HRCT scan not being 
consistent with the eligibility criteria, the subject cannot be rescreened. If an eligible HRCT or 
PET scan has been completed, however, and if the subject failed screening for other reasons and 
is re-screened successfully, the HRCT and PET scan do not need to be repeated so long as all 
other Inclusion/Exclusion criteria are satisfied on re-screening and the HRCT and PET scan were 
performed within 3 months of re-screening. 
Note: An HRCT and/or PET/CT as part of clinical care may be used as screening scans as long 
as the scans are performed within 4 weeks of the Screening Visit and are uploaded and deemed 
of acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study 
inclusion, it needs to be obtained again as part of the study inclusion procedures. 
Demographics, screen-fail details, eligibility criteria, assessments completed during the 
Screening Visit, and any SAEs must be completed and entered into the eCRF for all subjects 
who screen fail. 
4.4.2. 
Discontinuation of Study Treatment 
4.4.2.1. 
Permanent Cessation of Study Drug 
Study drug administration may be halted for any of the following reasons, but are not limited to: 
• A life-threatening or serious adverse effect; 
• Noncompliance, including refusal of the drug and/or failure to adhere to the study 
requirements (e.g., OCS taper, discontinuation of ISTs) as specified in the study protocol; 
• The Investigator decides that, in the interest of the subject, it is not medically acceptable 
to continue participation in the study; 
• Pregnancy;  
• Subject withdraws consent; 
• Use of prohibited medication;  
• The Sponsor decides to terminate the study. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 48 
Temporary or permanent cessation of study drug administration is NOT considered to be 
withdrawal of consent from study participation unless the subject explicitly withdraws informed 
consent. 
Refer to Section 4.4.2.3 for follow-up of subjects who permanently discontinue study drug.  
4.4.2.2. 
Temporary Cessation of Study Drug 
Study drug may temporarily be stopped for safety reasons at the discretion of the Investigator; 
however, no more than 1 total doses during the Double-blind Treatment Period may be missed. If 
2 total doses during the Double-Blind Treatment Period are missed, or if the Investigator 
unblinds subject data for safety purposes, study drug will be permanently withdrawn and follow-
up procedures as described in Section 4.4.2.3 will apply. 
4.4.2.3. 
Follow-up for Subjects Who Are Withdrawn from Study Drug 
If a subject permanently discontinues study drug prior to the last study drug administration 
during the Double-blind Treatment Period, the subject should attend an Early Termination (ET) 
Visit as described in the SOA in Appendix 1. Thereafter, the subject should subsequently attend 
visits in the Follow-up Period as specified in the SOA. 
If a subject will not agree to continue with study visits and study assessments, but will agree to 
phone call assessments, the subject should complete the phone/telemedicine visits in the Follow-
up Period as specified in the SOA in Appendix 1. 
4.4.2.4. 
Subject Discontinuation/Withdrawal of Consent 
Subjects may withdraw from the study at any time, for any reason, and may leave the study 
without specifying a reason at his/her own request. Additionally, subjects may request 
destruction of any blood/plasma samples taken and not tested, and the Investigator must 
document this in the site study records. 
The Investigator should make all efforts to obtain information about possible underlying AEs 
leading to the decision to withdraw from study participation. Any AE or SAE information 
elicited must be documented in the subject’s source documents and the eCRF. Refer to the SOA 
(Appendix 1) for data to be collected at the time of study discontinuation and follow-up and for 
any further evaluations that need to be completed. 
Unless the subject who prematurely discontinues trial participation specifically withdraws 
consent for any follow-up contact, all subjects will continue to be contacted at the same visit 
interval through the end of the study to obtain their health status. Investigators and site staff 
should encourage subjects to allow as much follow-up as possible and will need to clearly 
identify and document in writing as to which of the following options the subject has chosen. 
• The subject has withdrawn from further treatment with study drug but will agree to 
continue with study visits as described in Section 4.4.2.3; 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 49 
• The subject has withdrawn from further treatment with study drug, will not agree to 
continue with study visits and study assessments, but will agree to phone call assessments 
in accordance with Section 4.4.2.3; 
• The subject is not willing to be contacted in accordance with the visit schedule but will 
allow the Investigator access to their medical records; 
• The subject is not willing to allow any direct contact, access to medical records, or 
contact with a care provider. In this case, public records may be used to confirm vital 
status at the end of the study. 
If a subject decides to withdraw consent from study participation, it is necessary to ensure that 
relevant safeguards are put in place to maintain the individual’s safety in the case of any future 
safety issues that are discovered. In this case, the decision to withdraw informed consent should 
be put in writing and, if possible, signed by the subject or subject’s representative. A copy of this 
document should be maintained at the study site (with key data items recorded in the eCRF). 
This written information should specify which aspect(s) of the study consent is being withdrawn 
as described below. In accordance with International Conference for Harmonisation (ICH) 
guidelines, FDA guidance, and other international ethical directives, data that have already been 
collected and incorporated into the study database, including the results of laboratory assays, will 
continue to be processed. In addition, every effort should be made to have the subject return to 
the clinic for the final EOT Visit and complete the Follow-up Period as described in the SOA 
(Appendix 1). 
If the subject refuses to withdraw consent in writing, the site must document, and the 
Investigator must attest by signature the reason for the subject’s failure to withdraw the consent 
in writing. The Sponsor or designee should be immediately notified. 
4.4.2.5. 
Liver Injury 
Discontinuation of study treatment for abnormal liver tests should be considered by the 
Investigator when a subject meets one of the conditions outlined in the algorithm in Figure 2 or if 
the Investigator believes that it is in the best interest of the subject. In all cases of suspected liver 
injury, a discussion with sponsor or sponsor designee is required prior to withdrawing the 
subject. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 50 
Figure 2. 
Liver Injury Stopping Criteria 
 
Suggested actions and follow-up assessments can be found in Appendix 6. 
4.4.2.6. 
Cardiac Changes 
If a clinically significant finding is identified (including, but not limited to changes from baseline 
in QTcF after enrollment, the Investigator or qualified designee will determine if the subject can 
continue in the study and if any change in subject management is needed. This review of the 
ECG printed at the time of collection must be documented. Also refer to section 7.3.3 
Electrocardiograms. Any new clinically relevant finding should be reported as an AE. 
A subject who meets the following criterion based on the average of triplicate ECG readings will 
be withdrawn from the study: 
• QTcF > 500 msec OR uncorrected QT > 600 msec. 
For subjects with underlying bundle branch block, follow the discontinuation criteria listed in 
Table 2. 
Table 2. 
Discontinuation Criteria for Subjects with Underlying Bundle Branch Block 
Baseline QTc with Bundle Branch 
Block 
Discontinuation QTc Threshold with Bundle 
Branch Block 
< 450 msec 
≥ 500 msec 
450 to 480 msec 
≥ 530 msec 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 51 
4.4.2.7. 
Pregnancy 
For all female subjects of childbearing potential, a pregnancy test will be performed at the times 
indicated in the SOA (Appendix 1). Subjects testing positive for pregnancy at screening or prior 
to dosing will be ineligible for study participation. Subjects testing positive for pregnancy during 
the study will be withdrawn from the study. Refer to Section 7.4.3 for follow-up procedures for 
subjects who become pregnant during the study. 
4.4.3 
Lost to Follow-up 
A subject will be considered lost to follow-up if he/she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. 
The following actions must be taken if a subject fails to return to the clinic for a required study 
visit: 
• The site must attempt to contact the subject and reschedule the missed visit as soon as 
possible, counsel the subject on the importance of maintaining the assigned visit schedule 
and ascertain whether or not the subject wishes to and/or should continue in the study; 
• In cases in which the subject is deemed lost to follow-up, the Investigator or designee 
must make every effort to regain contact with the subject (where possible, 3 phone calls 
and, if necessary, a certified letter to the subject’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the subject’s 
medical record. This level of diligence is necessary to obtain (at minimum) vital status 
(whether the subject is alive), and thus avoid being lost to follow-up for efficacy and 
safety assessments; 
• Should the subject continue to be unreachable, he/she will be considered lost to follow 
up. In this case, every attempt should be made to search public health records for the 
subject’s vital status and document findings in the eCRF or Source Document 
4.4.4. 
Subject Replacement 
Subjects who are withdrawn from the study may not re-enter the study and will not be replaced. 
4.5. 
Study Termination 
4.5.1. 
Early Termination of the Study 
The Sponsor reserves the right to close a study site or terminate the study at any time for any 
reason at the sole discretion of the Sponsor. If the Data Monitoring Committee (DMC), Sponsor, 
or regulatory officials discover conditions arising during the study that indicate that the study 
should be halted or terminated, this action may be taken after appropriate consultation between 
Sponsor and the DMC. Full details on the roles of the DMC will be provided in the DMC 
charter.  

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 52 
Conditions that may warrant termination of the study include, but are not limited to, the 
following: 
• The discovery of an unexpected, serious, or unacceptable risk to the subjects enrolled in 
the study; 
• AEs unknown to date (i.e., not previously reported in any similar investigational study 
drug trial with respect to their nature, severity, and/or duration); 
• Increased frequency and/or severity and/or duration of known, anticipated, or previously 
reported AEs (this may also apply to AEs defined at check-in as baseline signs and 
symptoms); 
• Medical or ethical reasons affecting the continued performance of the study; 
• Difficulties in the recruitment of subjects; 
• A decision on the part of the Sponsor to suspend or discontinue testing, evaluation, or 
development of the study drug. 
Study sites will be closed upon study completion. A study site is considered closed when all 
required documents and study supplies have been collected and a study site closure visit has been 
performed. In the event of premature termination of the trial for safety reasons, the Sponsor will 
inform the regulatory authorities consistent with local reporting requirements. 
4.5.2. 
Early Termination of a Study Center 
Conduct of the study at a particular center may be terminated by the Sponsor or Investigator for 
the following reasons, but are not limited to: 
• Failure of the Investigator to comply with the protocol, the requirements of the 
Institutional Review Board (IRB)/Ethics Committee (EC) or local regulatory and/or 
health authorities’ regulations, the Sponsor's procedures, or ICH/Good Clinical Practice 
(GCP) guidelines; 
• Inadequate recruitment of subjects by the Investigator; 
• Submission of knowingly false information from the research facility to the Sponsor, 
Sponsor-designated contract research organization (CRO) or vendors, Study Monitor, the 
FDA, European Medicines Agency, and/or other applicable Regulatory Authorities. 
The Investigator may initiate study site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
If a study center or Investigator is terminated, the Sponsor will make all efforts possible to have 
another investigative site assume responsibility for continuing trial activities. 
Study termination and follow-up will be performed in compliance with the conditions set forth in 
the following sections of the Code of Federal Regulations (CFR): 21 CFR 312.50 and 21 CFR 
312.56, and other local regulatory requirements. In the event of premature termination of the trial 
for safety reasons, the Sponsor will inform the regulatory authorities consistent with local 
reporting requirements. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 53 
5. 
STUDY TREATMENT 
After randomization, subjects will be administered study drug 150 mg or placebo via SC 
injection on Day 1 (Baseline Visit - Week 0) and then at Weeks 2, 6, 10, 14, 18 and 22. If the 
subject is eligible and willing to continue onto the OLE Period, subjects will receive study drug 
150 mg via SC injection at Weeks 26, 30, 34, 38, 42, 46, and 50 regardless of treatment in the 
Double-blind Treatment Period. 
The study drug eCRF will be completed each time study drug is dispensed (See SOA, 
Appendix 1). 
5.1. 
Treatments Administered 
Namilumab is an investigational medicinal product that is not currently authorized for use in any 
country. 
The identity, potency/strength, and appearance of the study drugs used are presented in Table 3. 
It should be noted that the vials for both placebo and study drug will be masked to maintain the 
blind. 
Table 3. 
Description of Study Treatments 
Study Treatment Name 
Namilumab 
Placebo 
Dosage Formulation: 
Solution for injection 
Solution for injection 
Unit Dose 
Strength(s)/ Dosage Level(s): 
150 mg 
Each vial contains 1.2 mL 
Each vial contains 1.2 mL 
Route of Administration: 
Subcutaneous (SC) injection, 
which may be administered in the 
thigh, abdomen, or upper arm. 
Subjects will be observed for 
approximately 30 minutes 
(± 5 minutes) following the SC 
injection for adverse reactions.  
Vital signs should also be assessed 
at approximately 30 minutes 
(± 5 minutes) 
SC injection, which may be 
administered in the thigh, abdomen, 
or upper arm. 
Subjects will be observed for 
approximately 30 minutes 
(± 5 minutes) following the SC 
injection for adverse reactions.  
Vital signs should also be assessed 
at approximately 30 minutes 
(± 5 minutes) 
Dosing Instructions: 
1 mL administered 
1 mL administered 
Packaging and Labeling: 
Study Treatment will be provided 
in a sterile, single use, glass vial 
containing 1.2 mL of solution. 
Each vial will be labeled as 
required per country requirement. 
Study Treatment will be provided in 
a vial containing 1.2 mL of solution. 
Each vial will be labeled as required 
per country requirement. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 54 
5.2. 
Preparation, Storage, Handling, and Accountability 
Study drug will be provided in sterile, single-use, masked glass vials. Each vial contains 1.2 mL 
drug product or placebo solution to ensure a withdrawal volume of 1 mL for SC injection. 
Masked syringes will be used for administration of the study drug to maintain the blind. Refer to 
the Pharmacy Manual for further details. 
The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study drug received and any discrepancies are reported and 
resolved before use of the study drug. 
Study drug and placebo must be stored at 2°C -8°C (36°F -46°F). 
Study drug must be stored in a secure, environmentally controlled, and monitored (manual or 
automated) area in accordance with the labeled storage conditions with access limited to the 
Investigator and authorized site staff. 
Only subjects enrolled in the study may receive study drug and only authorized site staff may 
supply or administer study drug. 
Traceability is accounted for and overseen using Interactive Response Technology (IRT) for 
receipt, dispensing, return by patient, and destruction or return to depot. 
5.2.1. 
Return of Study Drug 
Vials of used, partially used, and unused study drug products should be retained until the Clinical 
Research Associate (CRA) has been able to complete drug accountability and reconciliation. If 
retention of used vials is not allowed per site standard operating procedure(s) then request for 
immediate destruction must be approved by the Sponsor. 
Upon completion or termination of the study, all unused and/or partially used study drug must be 
returned to the Sponsor or designee, if not authorized by the Sponsor to be destroyed at the site. 
All study drug returned to the Sponsor or designee, or other authorized party must be 
accompanied by the appropriate documentation and be clearly identified by the protocol number 
and study site number on the outermost shipping container. Returned supplies should be in the 
original vials (e.g., vials that have clinical labels attached). Empty vials should not be returned to 
the Sponsor or designee. It is the Investigator’s responsibility to arrange for disposal and 
destruction of all empty vials, provided that procedures for proper disposal have been established 
according to applicable federal, state, local and institutional guidelines and procedures, and 
provided that appropriate records of disposal are kept. The return of unused study drug should be 
arranged by the assigned CRA. 
5.2.2. 
Destruction of Study Drug 
If study drug is to be destroyed at the site, it is the Investigator’s responsibility to ensure that 
arrangements have been made for the disposal, written authorization has been granted by the 
Sponsor, procedures for proper disposal have been established according to applicable 
regulations and guidelines and institutional procedures, and appropriate records of the disposal 
have been documented and provided to the Sponsor or designee. Unused study drug can only be 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 55 
destroyed after being inspected, reconciled by the responsible CRA and Sponsor approval has 
been obtained in writing. 
Further guidance and information for the final disposition of unused study drug are provided in 
the Pharmacy Manual. 
5.3. 
Treatment Assignment and Administration 
Once a subject is eligible for study participation, the subject will be randomized 1:1 at the 
Baseline Visit to study drug or placebo using the IRT system. Randomization will be stratified 
by IST use at baseline. Study drug will be dispensed at the study visits summarized in the SOA 
(Appendix 1). Study drug will be administered by SC injection, which may be administered in 
the thigh, abdomen, or upper arm. Subjects will be observed for approximately 30 minutes (± 5 
minutes) following study drug administration.  
At the Investigator’s discretion a Mobile Health Professional (MHP) service may be utilized to 
administer study drug at home (in applicable countries) on the in-home visit days per the SOA 
(Appendix 1). The MHP service will follow the same requirements for storage and accountability 
for study drug as the study site personnel as documented in the MHP written guidance materials. 
Returned study drug should not be re-dispensed to the subjects. 
5.3.1. 
Dose Modification 
Study drug dose reductions and escalations will not be allowed. If a dose reduction is needed, a 
single dose may be omitted, or the subject should be discontinued from study drug. If 2 total 
doses are missed, or if study drug is permanently discontinued, follow-up procedures as 
described in Section 4.4.2.3 will apply. 
5.3.2. 
Mobile Health Professional 
At applicable sites, certain study procedures may be performed by a MHP service or (at sites 
with established teams) by appropriately qualified site personnel at the subject's home or another 
suitable location, to improve access and convenience for subjects participating in the study. The 
Investigator at a participating site will determine if the MHP services are appropriate for a 
subject, MHP services will be scheduled on specified visit days, to allow for relevant 
assessments to be performed by the MHP. 
The schedules of assessments (Appendix 1) will specify the assessments that may be performed 
by an MHP. 
For participating sites without an established MHP team, the Sponsor may select a health care 
company that will be responsible for providing MHP services for participating sites (the MHP 
vendor). The MHP vendor is responsible for ensuring that all MHPs are licensed, qualified, and 
in good standing, as per applicable regulations, and that appropriate background checks have 
been performed. All MHP requirements, procedures and documentation requirements are 
contained within the MHP guidance materials. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 56 
5.4. 
Blinding 
Study drug and placebo are not visually identical. Study drug will be provided in a blinded 
fashion and packaged and labeled to protect the blind. Sites will be provided with masked 
syringes to administer the study drug. 
Subjects will be randomized 1:1 to study drug or placebo using the IRT. At the time of 
randomization, subjects will be assigned a randomization number by the IRT. 
Computer-generated randomization lists will be prepared by the study sponsor or delegate. The 
randomization lists will be provided to an IRT vendor, who will maintain the codes. Sponsor 
personnel responsible for bioanalytics and unblinded statistician responsible for DMC output 
will have access to the randomization list as will pharmacovigiliance and the 24-hour emergency 
medical cover physician. Investigators, participants, and study personnel will remain blinded 
before the unblinded analysis at Week 26. 
 
The Investigator will have the ability to unblind a subject using the IRT system. The study blind 
may be broken by the Investigator using the IRT if, in the opinion of the Investigator, it is in the 
subject’s best interest to know the study drug assignment. The Sponsor must be notified before 
the blind is broken unless identification of the study drug is required for a medical emergency in 
which the knowledge of the specific blinded study drug will affect the immediate management of 
the subject’s condition. 
5.5. 
Treatment Compliance 
5.5.1. 
Study Drug Compliance 
The Investigator must maintain accurate records of study drug receipt, dispensing information, 
and disposition. Sponsor will provide forms to facilitate inventory control, if the staff at the 
investigational site does not have an established system that meets these requirements. 
Instructions for the return of used vials for visits that occur at home by a MHP will be provided 
in the MHP guidance materials. 
Treatment compliance will be calculated based on the number of used vials returned for each 
subject. 
5.5.2. 
Oral Corticosteroid Use and Taper Compliance 
Oral Corticosteroids (OCS) will be self-administered by the subjects during the study. On a daily 
basis, subjects will be required to complete an eDiary to document their steroid intake. The site 
must review and document a Subject’s compliance with OCS use and taper at each study visit. 
The site must also enter all doses and start and end dates in the concomitant medication pages in 
the eCRFs and source, during the oral corticosteroid tapering period and weekly throughout the 
study until the subject completes their EOS Visit.  
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 57 
6. 
CONCOMITANT THERAPIES AND OTHER RESTRICTIONS 
6.1. 
Concomitant Therapy 
Any medication or vaccine (including over the counter or prescription medicines, vitamins, 
and/or herbal supplements) that the subject is receiving at the time of enrollment or receives 
during the study must be recorded along with: 
• Reason for use; 
• Dates of administration including start and end dates; 
• Dosage information including dose and frequency. 
The Medical Monitor should be contacted if there are any questions regarding concomitant or 
prior therapy. 
6.2. 
Prohibited Medications/Therapies 
The following medications are prohibited beginning 6 months prior to screening, during 
screening, and during the study: 
• Recombinant GM-CSF (e.g., sargramostim, molgramostim, filgrastim, lenograstim, 
pegfilgrastim, lipefilgrastim); 
• Kinase inhibitors, including JAK inhibitors (e.g., baricitinib, tofacitinib, ruxolitinib, 
upadacitinib) and Bruton’s tyrosine kinase inhibitors (e.g., ibrutinib, acalabrutinib, 
zanubrutinib); 
• Biologic agents targeting one or more specific cytokines or cytokine receptors, including 
but not limited to mAbs inhibiting TNF (e.g., adalimumab, etanercept, infliximab, 
golimumab, certolizumab), interleukin (IL)-1 (e.g., canakinumab), IL-6 
(e.g., tocilizumab, sarilumab, siltuximab), IL-17 (e.g., secukinumab, ixekizumab, 
brodalumab), IL-12/23 (e.g., ustekinumab), selective inhibitors of IL-23p19 
(e.g., guselkumab, tildrakizumab, risankizumab); 
• Biologic agents targeting one or more specific molecules expressed on immune cells, 
including but not limited to monoclonal antibodies against CD20 (e.g., rituximab) and 
CD3 (e.g., otelixizumab, teplizumab, visilizumab); 
• Agents targeting the complement pathway (e.g., eculizumab, berinert, cinryze); 
• Intravenous or SC immunoglobulin; 
• FcRn inhibitors (e.g., efgartigimod); 
• Agents consisting of ILs or interferons (e.g., IL-2 [e.g., aldesleukin], interferon alpha-2b 
or beta-1a, IL-1 receptor antagonist [e.g., anakinra]); 
• EVUSHELD administration is not allowed during the Double-blind Treatment Period of 
the study; Note: EVUSHELD administration is allowed during the OLE Period of the 
study (consistent with provisions of any local regulatory authorization) at the clinical 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 58 
discretion of the Investigator. If used in the OLE Period, administration of EVUSHELD 
should occur approximately 14 days (± 2 days) prior to or following administration of 
study investigational product. 
• Any other investigational/unapproved agent; 
• Vaccines in general are not permitted with the exception of COVID-19 booster shots and 
routine influenza shots. 
The Medical Monitor should be contacted if there are any questions regarding whether a 
medication is prohibited. If a Prohibited Medication must be used due to clinical decline due to 
pulmonary sarcoidosis, the medication will be counted as a rescue medication and subject will be 
discontinued from study drug. If a prohibited medication must be used for other reasons, the 
subject will be discontinued from study drug. 
ISTs (all routes of administration other than topical or ophthalmic) including methotrexate, 
azathioprine, mycophenolate mofetil, (hydroxy)chloroquine, leflunomide, and sulfasalazine, 
must be stopped at randomization and prohibited throughout the study unless part of rescue 
treatment. ISTs given as rescue treatment are subject to the rescue requirements discussed in 
Section 6.4.  
The following scenarios are allowed, if necessary: 
• Use of short-course OCS (≤ 14 days) for the purpose of treating a non-sarcoidosis- 
related event (e.g., an acute allergic reaction, acute contact dermatitis); the patient must 
return to their pre-treatment baseline by Day 15 
• Use of inhaled corticosteroids or bronchodilators (e.g., long-acting beta agonists or long-
acting muscarinic agonists), topical or ophthalmic therapy for skin or eye sarcoid disease 
6.3. 
Contraception 
Females of childbearing potential who participate in this study must use a highly effective 
contraceptive method from at least 4 weeks prior to randomization, throughout the study, and for 
at least 18 weeks post last dose of study drug. For this study, females are of childbearing 
potential following menarche and until becoming post-menopausal unless permanently sterile. 
Permanent sterilization methods include total hysterectomy, bilateral oophorectomy, bilateral 
salpingectomy, bilateral tubal ligation, or bilateral hysteroscopic sterilization at least 3 months 
prior to screening. A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. Any use of hormonal contraception must be documented in the 
subject’s chart as a concomitant medication. 
For this study the following methods of contraception are acceptable highly effective 
contraceptive measures (based on annual failure rate of < 1% when used consistently and 
correctly): 
• Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation: 
o Oral; 
o Intravaginal; 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 59 
o Transdermal. 
• Progestogen-only hormonal contraception associated with inhibition of ovulation: 
o Oral; 
o Injectable; 
o Implantable. 
• Intrauterine device; 
• Intrauterine hormone-releasing system; 
• Vasectomized male partner provided that that partner is the sole sexual partner of the 
female study subject; 
• Sexual abstinence: Note: Sexual abstinence is considered a highly effective method only 
if defined as a refraining from heterosexual intercourse during the entire study period of 
risk associated with the study treatments; for this study that includes from the time the 
subject has been randomized through 18 weeks after last dose of study drug. The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the 
clinical trial and the preferred and usual lifestyle of the subject. The Investigator must 
confirm at every clinic visit that the subject is still practicing sexual abstinence and 
document the discussion in the subject’s source documents. 
Male subjects must agree to condom use when having sexual intercourse with female partners of 
childbearing potential and attest that female partners of childbearing potential are using a form of 
birth control as described above for at least 4 weeks prior to randomization/enrollment, 
throughout the study, and for 18 weeks following the last dose of study drug. 
Urine pregnancy testing for all female subjects of childbearing potential will be performed as 
specified in Appendix 1. Any positive urine test result must be confirmed based on a serum 
pregnancy test. The Investigator may perform additional pregnancy tests at their discretion or as 
required by local regulations. 
6.4. 
Rescue  
At randomization, subjects taking OCS will be required to taper their OCS (as described in 
Appendix 7). In addition, any subject taking ISTs (for example methotrexate, 
hydroxychloroquine; see also Section 6.2) will be required to stop these medications. Subjects 
may experience a worsening of their sarcoidosis symptoms and/or signs at any time during the 
study. The Investigator should instruct subjects to contact study staff immediately if they 
experience symptoms and feel that they may need therapy. If a subject has clinically significant 
worsening of sarcoidosis symptoms and/or signs “rescue” treatment may be instituted by the 
Investigator at any point in the study (see Section 3.1.5.1); however, administering this treatment 
is not encouraged until after pulmonary function testing at Week 6 during the Double-blind 
Period. 
If the subject does have worsening symptoms and/or signs, especially of the respiratory system, 
the Investigators should ascertain whether these new findings are due to acute co-morbid 
illnesses (bronchitis/pneumonia, asthma exacerbation, etc.) or due to worsening of sarcoidosis 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 60 
disease activity. Treatment of an acute co-morbid illness with a short course of OCS (≤ 14 days) 
is allowed, but the patient should taper to their pre-illness dose by Day 14.  
To maintain study integrity, it is highly encouraged that Investigators do not rescue subjects 
unless absolutely necessary, i.e., only if the subject’s symptoms warrant intervention or there is 
clinically significant worsening where it would be unethical to withhold treatment.  
If an Investigator deems that rescue treatment is medically necessary, OCS is the preferred 
rescue medication and the lowest effective dose with the shortest duration should be used. Prior 
to providing rescue treatment (Section 6.4, every effort should be made to complete the rescue 
form and all assessment as specified under the Week 26 visit as outlined in Appendix 1.  
During the Double-blind Treatment Period, only the first episode of rescue treatment requires a 
rescue eCRF page  to be completed and all assessments as specified under the Week 26 visit 
(Appendix 1). Similarly, in the OLE Treatment Period only the first episode of rescue treatment 
requires a rescue page and assessments as specified under the Week 26 visit (Appendix 1).  
If rescue treatment is initiated by the Investigator, study visits and study drug administration 
should continue as described in the SOA (Appendix 1); however, additional unscheduled clinic 
visits may be conducted at the Investigator’s discretion. If study drug is missed or discontinued 
(temporarily or permanently), procedures will be followed as outlined in Section 4.4.2.3. Once a 
subject’s status has stabilized, the Investigator may adjust the steroid and IST doses as clinically 
indicated.  
The definition of a rescue event is clinically significant worsening of pulmonary or extra-
pulmonary sarcoidosis that requires rescue treatment with prednisone or equivalent, start of an 
IST, or use of a prohibited medication. 
Clinically significant worsening of pulmonary sarcoidosis should include one or more of the 
following: new or worsening of pulmonary symptoms and/or signs related to sarcoidosis for ≥ 1 
week in duration including clinical testing (ppFVC or ppDLco reduction, worsening infiltrates 
on chest x-ray or on HRCT), indicating a worsening of pulmonary sarcoidosis disease activity 
and for which other causes have been ruled out based upon the judgment of the investigator (e.g., 
COVID, pneumonia, pulmonary embolism).  
The following will also constitute a rescue event, but will not require a rescue visit form or 
additional assessment to be performed:  
• A premature discontinuation associated with the lack of benefit; 
• Failure of the OCS taper i.e., the subject does not reach the goal pre-specified in the 
protocol (Appendix 7). 
• Prolonged use of increased OCS, other than as allowed for treatment of an acute co-
morbid illness, or restarting ISTs or prohibited immunomodulators for any reason 
(Section 6.2).  
OCS administered as rescue treatment should be used in accordance with the terms of its 
marketing authorization. IST used as rescue treatment for worsening sarcoidosis is considered 
use outside its marketing authorization; however, IST is widely accepted as second line treatment 
for both acute and chronic sarcoidosis and recommended according to clinical practice guidelines 
(Baughman, 2021). 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 61 
7. 
STUDY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarized in the SOA (Appendix 1). Adherence to the 
study design requirements, including those specified in the SOA (Appendix 1), is essential and 
required for study conduct. All study endpoints must be conducted with attention to the quality 
of the measurement, ensuring the greatest precision and accuracy of the endpoint measurement. 
All screening evaluations must be completed and reviewed to confirm that potential subjects 
meet all eligibility criteria. The Investigator will maintain a screening log to record details of all 
subjects screened and to confirm eligibility or record reasons for screening failure 
(Section 4.4.1), as applicable. Procedures conducted as part of the subject’s routine clinical 
management (e.g., blood count) and obtained before signing the Informed Consent Form (ICF) 
may be utilized for Screening or Baseline purposes provided the procedure met the 
protocol-specified criteria and was performed within the timeframe defined in the SOA 
(Appendix 1). 
7.1. 
Radiographic Assessments 
Details for the HRCT and [18-F] FDG-PET/CT imaging requirements, scanner validation, 
procedures for phantom image capture and data transfer requirements are described in the 
Participant Scanning Guide provided to all Investigators and collaborating radiology units. 
To avoid unnecessary radiation, it is recommended all other screening activities need to be 
completed prior to HRCT & PET scans for eligibility. In all cases the lowest radiation dose 
approach for imaging should be used. 
Total radiation exposure for study subjects will be minimized as far as possible as follows: 
• HRCT and [18-F] FDG-PET/CT scans should only be performed after subjects have 
completed other screening requirements successfully; 
• If possible combined HRCT/PET can be performed, if this is not possible, low resolution 
CT scanning for [18-F] FDG-PET/CT should be performed in addition to the HRCT; 
• The lowest dose of injectable radioisotope should be used per the guidance in the 
Participant Scanning Guide. 
Scans must be of sufficient quality to allow assessment of inclusion criteria. If insufficient, they 
must either be repeated, or the subject not randomized. 
Subjects will undergo up to one HRCT scan and one [18-F] FDG-PET/CT scans; cumulative 
radiation exposure from these scans will range from 8.4 mSv to 21.4 mSv, depending primarily 
on CT technique used. 
The central reader of HRCT and PET/CT will not document or report incidental findings on 
these radiographic assessments. Investigators are responsible for assuring local review of these 
assessments for incidental findings. The local review must be documented in source records, 
signed and dated by the Investigator. If no incidental finding is detected, it is sufficient to note 
this on the source document. If incidental findings are detected, they should be detailed with a 
statement whether “not clinically significant” or “clinically significant”, the latter defined when 
any clinical management, e.g., follow-up or treatment, is ordered. All clinically significant 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 62 
findings should be captured in EDC, either as an entry in Medical History if detected prior to 
first dose of Double-blind study drug or as an entry in Adverse Events if detected after first dose 
of Double-blind study drug. The Principal Investigator is also responsible for clinical follow-up 
of incidental findings including communication to the subject’s treating physician. 
7.1.1. 
High-Resolution Computed Tomography 
HRCT will be utilized in this study for assessing study eligibility (Appendix 1). The HRCT scan 
of the lung without contrast agent will be acquired at full inspiration according to parameters as 
listed in the separate Participant Scanning Guide. The scan will be interpreted locally to confirm 
evidence of parenchymal infiltrates consistent with pulmonary sarcoidosis and whether there are 
any incidental findings (see above). 
The scan is subject to central reading as described in the Independent Review Charter. The 
central read will determine final study eligibility compared to local interpretation.  
An HRCT performed as part of clinical care may be used as the Screening HRCT as long as the 
HRCT is performed within 4 weeks of the Screening Visit and is uploaded and deemed of 
acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study 
inclusion, it needs to be obtained again as part of the study inclusion procedures. 
Interpretation criteria will be described in the Independent Review Charter. 
7.1.2. 
[18-F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET)/ 
Computed Tomography (CT) 
All subjects will undergo [18-F] FDG-PET/CT imaging from head to mid-thigh with a 
reconstructed resolution of ≤ 5 mm during screening for assessing study eligibility 
(Appendix 1).Details of the scan requirements and procedures are contained in the Participant 
Scanning Guide. [18-F] FDG-PET/CT will be utilized in this study for assessing study eligibility. 
The scan will be interpreted locally to determine whether there are any incidental findings (see 
above).  
The scan is subject to central reading as described in the Independent Review Charter. The 
central read will determine final study eligibility compared to local interpretation.  
A PET/CT performed as part of clinical care may be used as the screening PET/CT as long as the 
PET/CT is performed within 4 weeks prior to the Screening Visit and is uploaded and deemed of 
acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study 
inclusion, it needs to be obtained again as part of the study inclusion procedures. 
The scan will be acquired according to the parameters as listed in the separate Participant 
Scanning Guide.  
Subjects with glucose levels above 11 mmol/L (200 mg/dL) should have their scan delayed or be 
rescheduled as appropriate. The blood glucose level measured prior to the radiotracer 
administration should be recorded in the image transmittal form. Subjects will have the 
radiotracer administered through an IV line, after which they will be positioned comfortably in a 
supine position as stated in the Participant Scanning Guide. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 63 
7.2. 
Efficacy Assessments 
Efficacy assessments and procedures should be performed in the sequence that is most practical 
for the site, as long as PROs are performed first, ECG, spirometry, and DLCo are performed in 
that sequence, and study drug administration is performed last. The study visits should follow the 
schedule as much as possible. Study drug is also to be administered on the same day. All 
procedures must occur no more than ±3 days from the scheduled date for the study visit. 
7.2.1. 
Pulmonary Function Tests 
Standardized spirometry equipment and procedure guidelines will be provided to all study sites 
for spirometry assessments. On visits at which spirometry and DLCO are to be performed 
spirometry should be performed first, followed by DLCO. 
7.2.1.1. 
Spirometry 
Spirometry will be performed to determine the subject’s FEV1 (L), ppFEV1, FVC (L), ppFVC, 
and FEV1/FVC. The predicted spirometry values will be determined using the 2012 Global Lung 
Function Equations. Spirometry assessments shall be obtained at the visits designated in 
Appendix 1. Spirometry will be conducted while the subject is in a seated position. Every 
attempt should be made to standardize the time of day that a subject undergoes lung function 
testing throughout the study, and it is preferable that the same trained individual performs the 
spirometry testing for a given subject. All Site Investigators performing spirometry testing must 
pass competency prior to subject testing. 
Spirometry results will be captured on standardized spirometry software and equipment and will 
be electronically transmitted and reviewed by a central over-reading service. Spirometry tests 
will be performed on a centralized spirometry system (provided to all sites by a central 
spirometry vendor) configured to the requirements of the study and in accordance with American 
Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. The quality of the tests 
will be reported back to the site Investigators. Within each spirometry session, it is required that 
subjects produce flow-volume loops of acceptable and repeatable quality, as per ATS/ERS 
recommendations. To obtain the highest FEV1 and the highest FVC a minimum of three 
acceptable FVC maneuvers must be performed (with a maximum of 8 efforts per session). 
Spirometry sessions must be stopped if the subject becomes tired or breathless. The details of 
these procedures will be described in the study pulmonary testing manual provided by the 
spirometry vendor. 
7.2.1.2. 
DLco Testing 
DLco is a measure of the quantity of carbon monoxide (CO) transferred per minute from alveolar 
gas to red blood cells (specifically hemoglobin) in pulmonary capillaries. DLco is expressed as 
mmol/min/kPa, that is, the millimoles of CO transferred per minute for each kilopascal of 
pressure difference across the total available functioning lung gas exchange surface. DLco 
maneuvers will be performed on the sites’ own testing equipment. The same calibrated 
equipment must be utilized throughout the study. The assessments shall be obtained at the visits 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 64 
designated in the SOA (Appendix 1). Subjects should avoid wearing restrictive clothing, 
vigorous exercise 30 minutes prior, eating a substantial meal 2 hours prior, and consuming 
alcohol 4 hours prior to testing. Subjects should be seated throughout the procedure and should 
be allowed several minutes of quiet breathing prior to testing to become accustomed to the 
mouthpiece and nose clip. A minimum of 2 acceptable maneuvers should be completed, with 
values within 0.67 mmol/min/kPa or 2mL.min-1mmHg-1 of each other. Subjects should be given 
a 4-minute window between maneuvers to allow for adequate elimination of the test gas from the 
lungs. Not more than 5 maneuvers should be attempted. Predicted DLco value will be produced 
using the 2017 Global Lung Function Initiative reference values. The DLco predicted value will 
be corrected for hemoglobin. The DLco results and reports will be entered into and electronically 
transmitted through the spirometry software. The details of this procedure will be described in 
the study pulmonary testing manual provided by the spirometry vendor. 
7.2.2. 
Patient Reported Outcomes 
The effect of study drug on selected PROs will be evaluated. Representative examples of the 
PROs used in this study are provided in Appendix 8 and include: 
• SGRQ; 
• mKSQ; 
• SGA; 
• LCQ; 
• BSGIC. 
Subjects will complete these assessments via electronic tablet as per the times specified in the 
SOA (Appendix 1). 
During the administration of the instruments, the subjects should be allowed to sit alone in a 
quiet environment to answer the survey questions. All specific PRO assessments during a visit 
should be conducted before any tests, procedures, or other consultations to prevent influencing 
the subject’s perception. Site staff and subjects will be given information on the rationale for 
including PROs in the study and clear instructions on how to complete the instruments. 
The staff at the study site/clinic should never help the subject choose an answer and must be 
neutral in their responses to the subject’s questions. The clinic staff are not allowed to interpret 
or rephrase the questions to the subjects. After the subject has completed the instruments, the 
study staff will collect the data and check for completeness only. 
The procedures for administration of the PRO instruments will be highlighted at the site training 
at each Investigator meeting. Study-specific PRO training will be given to all site Investigators 
and staff to ensure consistent oversight and management of the PRO administration process to 
ensure the highest possible quality of data. It is critical that all site Investigators and staff 
understand the rationale for including PROs in the protocol and the manner in which PRO 
instruments should be collected. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 65 
7.2.2.1. 
Saint George’s Respiratory Questionnaire 
The SGRQ (Appendix 8.1) is a self-administered questionnaire that contains 50 items distributed 
over three scales. The symptom scale assesses the severity of respiratory symptoms; the activity 
scale examines impairment in subject activity as a result of respiratory symptoms; and the impact 
scale evaluates effects of respiratory symptoms on overall function and wellbeing. Each scale 
can be scored from 0 to 100 and a total score represents the weighted average of the three 
sub-scores (Jones, 1992). 
7.2.2.2. 
Modified King's Sarcoidosis Questionnaire 
The KSQ is a self-administered questionnaire that contains 29 questions. The KSQ 
quickly assesses the impact sarcoidosis is having on a person’s life. The KSQ is a modular, 
multi-organ health status measure for subjects with sarcoidosis for use in the clinic and the 
evaluation of therapies. The mKSQ consists of five modules: General health status (10 items), 
expanded Lung (15 items), Medication (3 items), Skin (3 items) and Eye (7 items) (Patel, 2013). 
For the purposes of this trial additional questions removed during the original validation of the 
KSQ have been added to the Lung module, hence that part of the instrument is termed “expanded 
Lung”, and the overall KSQ is termed “modified” (Appendix 8.2).   
Scoring will be done for the KSQ domains of the mKSQ and separately for the expanded Lung 
domain of the mKSQ.  Higher numbers indicate better health.   
7.2.2.3. 
Subject Global Assessment 
The Subject Global Assessment (SGA) (Appendix 8.3), is a Subject reported outcome instrument 
used to assess their overall perception of the frequency and severity of sarcoid symptoms. The 
SGA, also sometimes termed Patient Global Assessment or PGA is a 5-point scale which can be 
completed in less than a minute. It has been widely adapted to clinical practice. Using a Likert 
scale; the Subject rates how he/she feels regarding their sarcoidosis in the previous 2 weeks prior 
to the Study visit based on the frequency and severity of their symptoms. The SGA is based on 
the PGA published by Baughman et al but has been modified to be in line with FDA’s 
recommendations on collection of patient global assessments (Baughman, 2016).  
7.2.2.4. 
Leicester Cough Questionnaire 
Chronic cough is a common condition which has a significant impact on quality of life. The LCQ 
(Appendix 8.4) a self-completed health related quality of life measure of chronic cough, the LCQ 
is a valid, repeatable 19 item self-completed quality of life measure of chronic cough which is 
responsive to change. It is a useful tool in clinical trials and longitudinal studies 
(Baughman, 2017).  Higher scores indicate better health-related quality of life.  

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 66 
7.2.2.5. 
Bothersomeness and Subject Global Impression of Change 
The assessment of BSGIC (Appendix 8.5) is a tool to assess the qualitative impact to the subject 
of their sarcoidosis on their worst, or most bothersome symptom that they have, and the 
perceived overall impact of their randomized treatment allocation to their disease management. 
At baseline, subjects will be asked to select from five symptom options, which one symptom is 
the most bothersome in their daily life: 
• Breathlessness. 
• Fatigue, tiredness, or lack of energy. 
• Disturbed sleep. 
• Cough. 
• Pain (any location). 
Subjects will then rate their most bothersome symptom on a 100 mm linear VAS from 0 mm – 
being not bothersome at all (no impact at all to activities of daily life), to 100 mm being the most 
bothersome imaginable (severely impacting all aspects of their daily life). 
At the final assessment at Week 26 (or withdrawal/ET); subjects will be reminded of their most 
bothersome symptom selected at baseline (but not their baseline score); then they will re-rate 
their symptom based on their EOS symptoms. 
Subjects will then also be asked to rate their global impression of treatment effectiveness, based 
on their perception of change from baseline on a 7-point scale. Subjects will answer the 
following question: 
Since you started your study medication, how have your sarcoidosis lung symptoms 
(coughing, breathlessness and/or chest pain/tightness) changed? 
Much 
Improved 
Moderately 
Improved 
Minimally 
Improved 
No Change 
Minimally 
Worse 
Moderately 
Worse 
Much 
Worse 
☐ 
☐ 
☐ 
☐ 
☐ 
☐ 
☐ 
7.2.3. 
Clinician Reported Outcomes 
The effect of study drug on selected clinician-reported outcomes will be evaluated. 
Representative examples of the Clinician Reported Outcomes used in this study is provided in 
Appendix 9: 
• ePOST; 
Clinicians will complete this assessment via electronic tablet as per the times specified in the 
SOA (Appendix 1). 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 67 
7.2.3.1. 
Extrapulmonary Physician Organ Severity Tool 
The ePOST (Appendix 9.1) has been previously developed and assessed in a prior trial of a 
biologic intervention in sarcoidosis. ePOST assesses disease involvement in 17 extrapulmonary 
organs. At each assessment each of the 17 organs is evaluated by the Study Investigator. Each 
organ is scored on a scale from 0 (not affected) to 6 (very severely affected), with the total score 
ranging from 0 to 102. 
Organ systems assessed are as follows: skin, peripheral lymph nodes, eyes, liver, spleen, central 
nervous system, peripheral nervous system, parotid/salivary glands, bone marrow, ear, nose, 
throat, cardiac, renal, bone/joint, muscle and gastrointestinal (Judson, 2008). 
7.2.4. 
Cytokine, Chemokine, and Sarcoidosis Biomarker Analyses 
Blood will be collected throughout the study according to the SOA (Appendix 1) to assess the 
effect of study drug on circulating proteins and to better understand sarcoidosis. Details for 
collection and sample handling can be found in the laboratory manual.  
Serum samples may be tested for inflammatory proteins (e.g., GM-CSF, IL-1, IL-6, TNF) 
using protein ELISA-based or other comparable methodology. 
Biomarkers related to the pathogenesis of sarcoidosis (e.g., soluble IL-2 receptor (sIL-2R), serum 
amyloid A, high-sensitivity CRP (hsCRP) will also be tested. 
Samples may be stored to assess at a future timepoint for additional biomarkers related to study 
drug or sarcoidosis. 
7.3. 
Safety Assessments 
Planned timepoints for all safety assessments are provided in the SOA (Appendix 1). 
Assessments for safety include vital signs, height, weight, physical examinations (PEs), ECGs, 
clinical laboratory assessments, and AEs. 
7.3.1. 
Vital Signs, Height, and Body Weight 
7.3.1.1. 
Vital Signs 
Vital signs (BP, heart rate, respirations, and temperature) will be measured after 5 minutes of 
rest, with the subject in a quiet setting without distractions (e.g., television, cell phones). Vital 
sign measurements should be taken prior to any blood collections taken during the visit. Vital 
sign measurements should also be taken approximately 15 minutes (± 5 minutes) prior to study 
drug administration and approximately 30 minutes (± 5 minutes) after administration of study 
drug. 
BP and heart rate measurements should be assessed in a seated position with a completely 
automated device; however, manual techniques may be used if an automated device is not 
available. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 68 
For the Screening Visit only, BP may be repeated 2 additional times at least 5 minutes apart if 
the subject does not meet inclusion/exclusion criteria. An average of the three systolic and 
diastolic readings may then be used for inclusion determination and should be entered into the 
eCRF. 
The same method (oral temperature preferred) for assessing temperature should be used at all 
visits for a particular subject. 
7.3.1.2. 
Height 
Standing height will be measured without shoes. 
7.3.1.3. 
Body Weight 
Body weight will be measured in kilograms using a scale with appropriate range and resolution, 
and it must be placed on a stable, flat surface. Subjects should remove their shoes and bulky 
layers of clothing (jacket/coat), so that only light street clothing remains. Subjects should also 
remove the contents of their pockets and remain still during the weight measurement. 
7.3.2. 
Physical Examinations 
A complete PE will include, at a minimum, assessments of the head, ears, eyes, nose, mouth, 
skin, lymph nodes and abdomen (liver and spleen), as well as the cardiovascular, respiratory, 
gastrointestinal, and neurological systems. 
A brief (targeted) PE will include, at a minimum, assessments of general appearance, the skin, 
and the cardiovascular and respiratory systems, and assessment of any subject reported 
symptoms. 
Investigators should pay special attention to clinical signs related to previous serious illnesses. 
PEs may be conducted by a physician, trained physician’s assistant, or nurse practitioner as 
acceptable according to local regulations. 
7.3.3. 
Electrocardiograms 
All scheduled ECGs should be performed after the subject has rested quietly for at least 10 
minutes in a supine position and prior to any blood collections. 
Single 12-lead ECGs will be obtained using Sponsor-provided equipment at timepoints outlined 
in the SOA (Appendix 1). In case of issues with Sponsor-provided equipment, local equipment 
may be used to obtain ECGs, but use of local equipment must be approved by Sponsor. These 
ECGs must also be submitted for central review.  
The initial review of the ECG for safety, printed at the time of collection and read locally using 
site procedures, must be documented in the source documents. The final assessment captured in 
EDC by Investigator or qualified designee should take into consideration the central 
cardiologist’s analysis, once available. Any clinically significant findings from the central 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 69 
cardiologist’s analysis must be reviewed by the Investigator or designee, to determine if an AE 
has occurred  
When triplicate ECGs are required (e.g., at screening if the initial QTcF is > 480 msec or as 
outlined in Section 4.4.2.6 to assess changes in QTcF or QT that exceed thresholds, 3 individual 
ECG tracings should be obtained as closely as possible in succession, but no more than 
2 minutes apart. When required, the QTcF times as reported by the central cardiologist’s 
overread should be averaged to make a final determination. 
7.3.4. 
Tuberculosis Screening 
Subjects will be screened for TB using an interferon gamma release assay (IGRA) as supplied by 
the central laboratory. IGRA will be tested during screening. Site personnel should follow the 
processing and analyses steps as outlined by the central laboratory manual. Ensure incubation 
steps are followed as appropriate. 
If results of the IGRA are indeterminant, the test may be repeated, and if a negative result is 
obtained, enrollment may proceed as normal if the subject is otherwise eligible.  
Subjects with repeat indeterminate IGRA results should have a different IGRA test, if available, 
and may be enrolled without anti-TB therapy after consultation with an infectious disease and/or 
pulmonary specialist (the Investigator may qualify if such a specialist) who determines that risk 
of infection is low (i.e., subject would be acceptable for immunosuppressant treatment without 
additional action or therapy). Such a determination should include discussion with the Study 
Medical Monitor and be documented in the subject’s source record. 
7.3.5. 
HIV and Hepatitis Screening 
During the study Screening Period, all subjects will be screened for HIV antibody (HIVAb), 
hepatitis B (hepatitis B surface antigen [HBsAg], hepatitis B surface antibody [HBsAb], and 
hepatitis B core antibody [HBcAb] with reflex testing as applicable), and hepatitis C (hepatitis C 
virus antibody [HCVAb] with reflex testing as applicable). Subjects with serologic evidence of 
infection with HIV, hepatitis B or hepatitis C must have a measurement of viral load by RT PCR 
that is undetectable prior to randomization to be eligible. 
Subjects with hepatitis B serology suggestive of prior vaccination (i.e., negative HBsAg, 
negative HBcAb and positive HBsAb) and provide documentation of hepatitis B virus 
vaccination will not require RT-PCR evaluation prior to randomization. 
7.3.6. 
Clinical Safety Laboratory Assessments 
See Appendix 4 for the list of clinical laboratory tests to be performed for screening and safety 
monitoring, and also for the SOA (Appendix 1) for the timing and frequency. 
The Investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study as an AE. The laboratory reports must 
be filed with the source documents.  

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 70 
Abnormal laboratory findings associated with the underlying disease are not considered 
clinically significant unless judged by the Investigator to be more severe than expected for the 
subject’s condition. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study or within approximately 18 weeks after the last dose of study drug should be 
repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the Investigator or Medical Monitor. 
If clinically significant values do not return to normal/baseline within a period of time judged 
reasonable by the Investigator, the etiology should be identified, and the Sponsor notified. 
All protocol-required laboratory tests must be conducted in accordance with the laboratory 
manual and the SOA (Appendix 1). 
If laboratory values from non-protocol-specified laboratory tests performed at the institution’s 
local laboratory require a change in subject management or are considered clinically significant 
by the Investigator (e.g., SAE or AE or dose interruption/discontinuation), then the results must 
be recorded. 
All collected biological samples will be analyzed for the objectives of the trial. The collected 
biological samples will be managed and stored in accordance with all national and local 
regulations after the completion of the informed consent process. Remainders of biological 
samples may be stored for the sponsor for 25 years, and may be used for future research, in 
accordance with local requirements as described in the informed consent form. 
7.3.7. 
Sample Requirements 
The maximum amount of blood collected from each subject over the duration of the study, not 
including any extra assessments that may be required, will be approximately 133.5 mL for 
subjects who participate in the Double-blind Treatment Period only (Table 4) and approximately 
191.5 mL for subjects who participate in both the Double-blind and OLE Treatment Periods 
(Table 5). Repeat or unscheduled samples may be taken for safety reasons or for technical issues 
with the samples. 
Table 4. 
Estimated Blood Sample Requirements Per Subject for Subjects who 
Participate in the Double-blind Treatment Period Only 
 
Approximate 
sample volume 
per collection 
Number of 
collection time 
points 
Approximate 
total volume 
collected (mL) 
Clinical laboratory: chemistry panel 
2.5 
8 
20 
Clinical laboratory: hematology panel 
2 
8 
16 
Clinical laboratory: lipids 
Included in Chemistry panel sample 
0 
hsCRP 
Included in Chemistry panel sample 
0 
HbA1C 
Included in Hematology panel sample 
0 
QuantiFERON® Gold/ IGRA 
4 
1 
4 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 71 
 
Approximate 
sample volume 
per collection 
Number of 
collection time 
points 
Approximate 
total volume 
collected (mL) 
Virology labs and DNA/RNA (hep B, hep C) 
9.5 
1 
9.5 
Virology HIV 
2.5 
1 
2.5 
Anti-GM-CSF autoAb 
3.5 
1 
3.5 
PK 
3.5 
5 
17.5 
ADA 
3.5 
3 
10.5 
Cytokine & chemokine panel 
3.5 
4 
14 
SAA  
2.5 
4 
10 
SP-D 
3.5 
4 
14 
Other sarcoidosis biomarkers 
3 
4 
12 
Total: 
133.5 
 
Table 5. 
Estimated Blood Sample Requirements Per Subject for Subjects who 
Participate in Both the Double-blind and OLE Treatment Periods 
 
Approximate 
sample volume 
per collection 
Number of 
collection time 
points 
Approximate 
total volume 
collected (mL) 
Clinical laboratory: chemistry panel 
2.5 
13 
32.5 
Clinical laboratory: hematology panel 
2 
13 
26 
Clinical laboratory: lipids 
Included in Chemistry panel sample 
0 
hsCRP 
Included in Chemistry panel sample 
0 
HbA1C 
Included in Hematology panel sample 
0 
QuantiFERON® Gold/ IGRA 
4 
1 
4 
Virology labs and DNA/RNA (hep B, hep C) 
9.5 
1 
9.5 
Virology HIV 
2.5 
1 
2.5 
Anti-GM-CSF autoAb 
3.5 
1 
3.5 
PK 
3.5 
8 
28 
ADA 
3.5 
5 
17.5 
Cytokine & chemokine panel 
3.5 
6 
21 
SAA  
2.5 
6 
15 
SP-D 
3.5 
4 
14 
Other sarcoidosis biomarkers 
3 
6 
18 
Total: 
191.5 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 72 
7.3.8. 
Pregnancy Testing 
Women of childbearing potential must have a urine beta human chorionic gonadotropin (β-hCG) 
pregnancy test at study visits indicated on the SOA (Appendix 1). Following a negative 
pregnancy test at screening and verification of appropriate contraception as outlined in 
Section 4.1 and Section 6.3, a negative pregnancy test result will be required prior to all radiation 
exposing procedures, and at Day 1 (baseline) prior to the subject receiving study drug and at 
subsequent visits where pregnancy testing is specified in the SOA (Appendix 1). Additionally, if 
the site staff become aware of a subject having a missed menstrual cycle between visits, the 
subject should come to the site for a urine pregnancy test (as an unscheduled visit if necessary). 
The Investigator may perform additional pregnancy tests at their discretion or as required by 
local regulations. 
For site visits, urine pregnancy tests will be performed at the site. For phone or telemedicine 
visits, female subjects will be required to complete a home urine pregnancy test and report the 
result to the Investigator at the time of the phone call/telemedicine visit. If a positive result is 
obtained, the Investigator will schedule an on-site visit at the clinic for a confirmatory serum 
pregnancy test. The Investigator may provide home urine pregnancy test kits to the subject where 
required. A positive urine β-hCG test must be followed up with a serum β-hCG pregnancy test. 
A positive pregnancy test prior to randomization requires exclusion from the study. A positive 
urine β-hCG test during the study after randomization requires immediate interruption of study 
drug until a serum β-hCG is performed and found to be negative. The subject must be 
discontinued from the study and followed if pregnancy is confirmed by a positive serum β-hCG. 
7.4. 
Adverse and Serious Events 
7.4.1. 
Adverse Events 
Adverse event definitions and assignment of severity and causality are detailed in Appendix 2. 
Nonserious AE reporting begins from the time the first dose of double-blind study drug has been 
taken and ends 18 weeks after the last dose of study drug.  
Any sign, symptom, or illness occurring prior to first dose of double-blind study drug will be 
captured in the medical history. Treatment-emergent adverse events are defined as any AE 
reported after the first dose of double-blind study drug. Adverse event definitions and assignment 
of severity and causality are detailed in Appendix 2. 
Adverse events will be elicited from the subject (or, when appropriate, from a caregiver, 
surrogate, or the subject’s legally authorized representative) by the study site staff using a 
non-leading question such as “How are you feeling today?” or “Have you had any health 
concerns since your last visit?” 
The Investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or serious AE (SAE) and remain responsible for 
following up AEs that are serious, considered related to the study drug or the study, or that 
caused the subject to discontinue the study drug (see Section 4.4.2). 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 73 
The Investigator, per routine practice, should report AEs with suspected causal relationship with 
OCS and IST used as rescue treatment to the marketing authorization holder (MAH) or 
manufacturer listed on the prescribing information. Reference the clinical trial number 
(EudraCT, EUCT, or NCT) in any rescue treatment safety report submitted to the MAH. A copy 
of the report should also be sent to the Sponsor using the email or fax numbers outlined in 
Section 7.4.2. 
7.4.2. 
Reporting Serious Adverse Events 
All SAEs, occurring after the signing of the ICF until 18 weeks after the last dose of study drug, 
and regardless of study drug relationship, must be reported immediately without exceeding 
24 hours of becoming aware of the event to appropriate Sponsor/contract research organization 
(CRO) Drug Safety representatives. The Investigator or study site personnel will provide the 
initial notification by completing the SAE page in the eCRF (which will trigger an automatic 
SAE alert email to safety contacts), which must include the Investigator’s assessment of the 
relationship of the event to study drug and must be signed by the Investigator. There may be 
situations in which minimal information is available. However, it is very important that the 
Investigator always makes an assessment of causality. The Investigator may change his/her 
assessment of the causality based on follow-up information and should amend the SAE report 
form accordingly. The causality assessment is one of the criteria used when determining 
regulatory reporting requirements. It is understood that SAEs occurring during the Screening 
Period, by definition, will not be assessed as related to the investigational drug because there is 
no investigational drug in the Screening Period. 
Serious Adverse event definitions and assignment of severity and causality are detailed in 
Appendix 2. 
Sponsor/CRO Drug Safety will forward SAE queries directly to the Investigator via email or 
through electronic data capture (EDC), requesting additional information. It is the Investigator’s 
responsibility to be diligent in providing this information to Sponsor/CRO as soon as it is 
available. SAEs will be followed until resolution, stabilization, or death. 
The Sponsor/CRO will report all SUSARs to the appropriate regulatory agencies, adhering to 
timelines for reporting outlined per the local regulatory requirements and ICH GCP Guidelines. 
SUSAR reports will also be submitted to EudraVigilance. 
If an event meets serious criteria and it is not possible to access the EDC, the SAE should be 
submitted by completing SAE form electronically using this email address: 
- 
SAEintake@fortrea.com  
If email access is not available, the SAE may be reported via fax using the below regional 
numbers or by phone hotline: 
US Fax# 1-888 887 8097 
EU Fax# 0800 633 5595 
Safety Hotline: 1-888-724-4908 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 74 
7.4.3. 
Pregnancy 
Although not considered an SAE (unless the event occurs with a serious outcome), pregnancy 
(Section 4.4.2.7) information on female subjects will be collected by the authorized safety 
designee. 
If a female subject becomes pregnant during the study, study drug should be discontinued 
immediately. The Investigator must complete and submit a Pregnancy Report Form (or 
designated form) immediately without exceeding 24 hours of awareness of the pregnancy. In 
addition, subjects who become pregnant will complete the EOS or ET evaluations according to 
the SOA (Appendix 1). 
Female subjects who become pregnant will also be followed to determine the outcome of the 
pregnancy and the presence or absence of a congenital abnormality will be documented by 
completion of a Pregnancy Outcome Reporting Form (or designated form) and should be 
submitted to the Sponsor once the outcome is known. 
Generally, follow-up will be no longer than 6 to 8 weeks following the estimated delivery date. 
Any premature termination of the pregnancy (spontaneous or intended) must also be reported. 
If a female partner of a male subject becomes pregnant during the study, the female partner must 
complete the female partner ICF and the same reporting and follow-up guidelines for female 
subjects must be followed. 
7.5. 
Pharmacokinetic Analysis 
Pre-dose blood samples will be collected into appropriately labeled tubes for measurement of 
study drug serum concentrations as specified in the SOA (Appendix 1) from all subjects who 
receive at least one dose of study drug or placebo. The actual date and time (24-hour clock time) 
of each sample will be recorded. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual. All samples must be processed and shipped as indicated to maintain sample 
integrity. Any deviations from the processing steps and any actions taken must be documented 
and reported to the Sponsor. 
A specific bioanalytical method (detailed in bioanalysis sample analysis plan) will be used to 
measure serum concentrations of study drug. 
7.6. 
Immunogenicity Analysis 
Blood samples will be collected as specified in the SOA (Appendix 1) from all subjects who 
receive at least one dose of study drug. A specific bioassay to determine development of ADA to 
study drug will be performed in serum using a tier approach, i.e., screening, confirmatory, and 
titer assessment. The impact of ADAs on the PK of study drug may be assessed. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 75 
8. 
SAMPLE SIZE AND DATA ANALYSES 
This section outlines the statistical analysis strategy and procedures for the study. If, after the 
study has begun, but prior to any unblinding, changes are made to the primary hypothesis, or the 
statistical methods related to the hypothesis, then the protocol will be amended (consistent with 
ICH Guideline E9). Changes to secondary or other non-confirmatory analyses made after the 
protocol has been finalized, but prior to unblinding, will be documented in the Statistical 
Analysis Plan (SAP) and referenced in the CSR for the study. Post hoc exploratory analyses will 
be clearly identified in the CSR. The PPK and E-R analyses will be performed based on 
modeling analysis plan (MAP) and reported separately from the final clinical study report. 
8.1. 
Determination of Sample Size 
It is planned to randomize approximately 100 subjects in this study (50 subjects per arm, 45 
evaluable subjects per arm assuming a 10% dropout).  
Table 6 lists the sample size (number of evaluable subjects per arm) for a range of possible rates 
of subjects requiring rescue treatment in the placebo group (from convenience sample, 
observational cohorts) and detectable differences between treatment groups (in the absence of 
data from randomized trials, the range has face validity as clinically relevant) at a power of 
approximately 80% and a two-sided significance level of 0.10 based on Fisher’s exact test. 
Assuming a placebo rate of 40%, 90 evaluable subjects (45 subjects per arm) will provide a 
power of approximately 80% to detect the 25% treatment difference at a 2-sided significance 
level of 0.10 based on Fisher’s exact test. 
Table 6. 
Sample Size Per Arm Under Different Scenarios 
Rate in 
Placebo 
Rescue Rate difference (Placebo - Namilumab) 
20.0% 
22.5% 
25.0% 
27.5% 
30.0% 
32.5% 
50% 
84 
66 
54 
44 
36 
31 
45% 
78 
61 
49 
41 
34 
28 
40% 
73 
57 
46 
37 
30 
24 
35% 
65 
51 
39 
32 
25 
21 
8.2. 
Analysis Populations 
The following analysis populations will be included for this study: 
8.2.1. 
Intent-to-treat (ITT) Population 
The ITT Population will include all randomized subjects. ITT subjects will be analyzed 
according to their randomized treatment. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 76 
8.2.2. 
Modified Intent-to-treat (mITT) Population 
The mITT Population will include all randomized subjects who receive any amount of double-
blind study treatment. The mITT will be analyzed according to the treatment assigned. This 
population will be used for efficacy analyses.  
8.2.3. 
Per-protocol (PP) Population 
The Per-Protocol (PP) Population will include all subjects in the mITT Population who have no 
major protocol violations which may impact effectiveness of the treatment. The PP Population 
will be used for supplementary analyses of the efficacy measurements. 
8.2.4. 
Safety Population (SP) 
The Safety Population (SP) will include all randomized subjects who receive any amount of 
study drug. The SP will be analyzed according to the treatment received. This population will be 
used for safety analyses. 
8.3. 
General Considerations 
All statistical analyses will be conducted using SAS, Version 9.4 or later. Demographic and 
baseline characteristics will be summarized by treatment group and overall for both Safety and 
mITT populations. For continuous measures the mean and SD will be summarized. Categorical 
variables will be described by the count and proportion in each category. 
8.4. 
Handling of Missing Data 
Analysis of the primary endpoint will be performed using a Cohcran-Mantel-Haenszel (CMH) 
test based on collected data. The reasons for premature discontinuation will be identified. 
Sensitivity analysis based on multiple imputation and assumptions of missing not at random, 
including tipping point analysis, for subjects who prematurely discontinue study treatment will 
be performed. Details on missing data sensitivity analyses will be pre-specified in the SAP. 
8.5. 
Efficacy Analyses 
8.5.1. 
Primary Efficacy Outcome Measure 
The primary efficacy endpoint is the proportion of subjects with a rescue event , identified as 
described in Section 6.4, during the Double-blind Treatment Period. The primary efficacy 
analysis will be performed using the mITT population. A CMH test stratified by use of IST at 
baseline will be used to compare the treatment difference. The difference in proportions between 
treatment groups and the confidence interval based on stratified Miettinen-Nurminen method 
will be provided. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 77 
The analysis will also be performed using the PP population. Supplementary analyses based on 
multiple imputation and tipping point analysis to account for subjects who prematurely 
discontinue the study treatment will also be performed. Details will be pre-specified in the SAP. 
8.5.2. 
Secondary Efficacy Outcomes Measures 
Unless otherwise specified, binary endpoints will be summarized using numbers and frequency. 
The CMH test, stratified by baseline IST usage, will be used for treatment comparison. 
Difference in proportions between treatment groups as well as the confidence interval based on 
stratified Miettinen-Nurminen method will be provided if needed. Continuous endpoints will be 
summarized using descriptive statistics. The continuous endpoints between the 2 treatment 
groups will be compared using a mixed model for repeated measures analysis with the treatment, 
visit, IST usage at baseline, and the interaction between treatment and visit as factors, and the 
baseline score as a covariate. Time to event endpoints will be summarized using Kaplan-Meier 
estimates. The treatment effects of the time to event endpoints will be evaluated using a log rank 
test stratified by use of IST usage at baseline. More details about the analysis methods will be 
described separately in the SAP. 
8.5.3. 
Adjustment of Multiple Comparisons 
There is only one primary hypothesis, and it will be tested at a 2-sided alpha of 0.10. 
No adjustments will be made to account for multiplicity for secondary and exploratory 
endpoints. P-values presented for these endpoints will be nominal p-values. 
8.6. 
Safety Analyses 
Safety variables include assessments of PEs, vital signs, electrocardiograms (ECGs), clinical 
laboratory measurements, and incidence of AEs or TEAEs. A TEAE is defined as any AE that 
newly appeared or worsened in severity on or after the initiation of active treatment. All safety 
analyses will be based on the SP. No formal statistical testing of safety endpoints will be 
performed. 
Summary tables will be provided for all AEs by treatment group. The incidence of AEs, study 
drug-related AEs, SAEs, and AEs leading to discontinuation of the study drug will be presented 
by the Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred 
term. In addition, the incidence of AEs by severity will be presented by SOC and preferred term. 
The AE summary tables will include counts of subjects. Therefore, if a subject experiences more 
than one episode of a particular AE, the subject will be counted only once for that event. If a 
subject has more than one AE that is coded to the same preferred term, the subject will be 
counted only once for that preferred term. Similarly, if a subject has more than one AE within a 
SOC, the subject will be counted only once in that SOC. 
Laboratory test variables will be summarized by treatment group and visit using descriptive 
statistics (number of subjects, mean, SD, minimum, maximum, and mean change from baseline). 
Shift tables (low, normal, high) between baseline and post-baseline timepoints will be presented 
by laboratory test and treatment group. Laboratory tests with categorical results that cannot be 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 78 
analyzed by change from baseline or shift table analysis will not be included in these summaries 
but will be summarized as counts and frequencies. Data obtained from laboratory tests not 
required by the protocol will not be summarized but will be listed. 
Descriptive statistics of vital signs and ECG results at each visit will be presented by the 
treatment groups. PE findings will be listed for each subject. 
8.7. 
Population Pharmacokinetic Analyses 
The PPK and E-R analyses will be performed based on the modeling analysis plan (MAP) and 
reported separately from the final clinical study report. 
8.8. 
Biomarkers 
The effect of namilumab on circulating biomarkers, and the correlations between biomarker and 
clinical endpoint changes will be performed and reported separately from the final clinical study 
report. 
8.9. 
Statistical Analysis Plan 
A detailed SAP will be finalized prior to unblinding and submitted as necessary to the regulatory 
agencies prior to unblinding.  
8.10. 
Analysis at the End of the Double-blind Treatment Period 
An unblinded analysis of efficacy and safety will be performed after all subjects have completed 
the Week 26 visit.  
8.11. 
Analysis at the End of the Open-label Treatment Period 
Unless otherwise specified, descriptive summaries will be provided for data collected during the 
Open-label Period after all subjects complete the Open-label Period. The details will be 
described in the SAP. 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 79 
9. 
REFERENCES 
Abu El-Asrar AM, Berghmans N, Al-Obeidan SA, Gikandi PW, Opdenakker G, et al. 2020. 
Local Cytokine Expression Profiling in Patients with Specific Autoimmune Uveitic Entities Ocul 
Immunol Inflamm. 28(3):453-62. 
Bargagli E, Prasse A. Sarcoidosis: A review for the internist. Intern Emerg Med. 2018 
Apr;13(3):325-331. doi: 10.1007/s11739-017-1778-6. Epub 2018 Jan 3. PMID: 29299831. 
Baughman RP, Grutters JC. 2015. New treatment strategies for pulmonary sarcoidosis: 
Antimetabolites, biological drugs, and other treatment approaches. Lancet Respir Med. 
3(10):813-22. 
Baughman RP, Field S, Costabel U, Crystal RG, Culver DA, et al. 2016. Sarcoidosis in America: 
Analysis based on health care use. AnnalsATS. 13(8):1244-1252. 
Baughman RP, Sweiss N, Keijsers R, Birring SS, Shipley R, et al. 2017. Repository corticotropin 
for chronic pulmonary sarcoidosis. Lung. 195(3):313-322. 
Baughman RP, Valeyre D, Korsten P, et al. ERS clinical practice guidelines on treatment of 
sarcoidosis. Eur Respir J. 2021 Dec 16;58(6):2004079. 
Becher B, Tugues S, Greter M. 2016. GM-CSF: from growth factor to central mediator of tissue 
inflammation. Immunity. 45(5):963-973. 
Beegle SH, Barba K, Gobunsuy R, Judson MA. 2013. Current and emerging pharmacological 
treatments for sarcoidosis: a review. Drug Des Devel Ther. 7:325-338. 
Benmerzoug S, Marinho FV, Rose S, Mackowiak C, Gosset D, et al. 2018. GM-CSF targeted 
immunomodulation affects host response to M. tuberculosis infection. Sci Rep. 8(1):8652. 
Broos CE, Koth LL, van Nimwegen M, In't Veen JCCM, Paulissen SMJ, et al. 2018. Increased 
T-helper 17.1 cells in sarcoidosis mediastinal lymph nodes. Eur Respir J. 51(3):1701124. 
Bryson BD, Rosebrock TR, Tafesse FG, Itoh CY, Nibasumba A, et al. 2019. Heterogeneous 
GM-CSF signaling in macrophages is associated with control of Mycobacterium tuberculosis 
Nat Commun. 10(1):2329. 
Buckley C, Simon Campos JA, Yakushin S, Zhdan V, Davy K, Inman D, et al. 2020. Efficacy, 
patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating 
factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, 
phase 2b, dose-ranging study. Lancet Rheumatol. 2: 677-688. 
Burmester GR, McInnes IB, Kremer JM, Miranda P, Vencovsky J, et al. Mavrilimumab, a Fully 
Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor α Monoclonal Antibody. 
Arthritis & Rheumatology. 2018;70(5):679-689. 
Callejas-Rubio et al Tumor necrosis factor-alpha inhibitor treatment for sarcoidosis. 
Therapeutics and Clinical Risk Management 2008:4(6) 1305–1313 
Campbell J, Nys J, Eghobamien L, Cohen ES, Robinson MJ, Sleeman MA. Pulmonary 
pharmacodynamics of an anti-GM-CSFR-α antibody enables therapeutic dosing that limits 
exposure in the lung. MABS. 2016;18(7):1398-1406. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 80 
Cid M, Unizony S, Pupim L, Fang F, Pirrello J, et al. 2020. Mavrilimumab (anti GM-CSF 
receptor α monoclonal antibody) reduces time to flare and increases sustained remission in a 
phase 2 trial of patients with giant cell arteritis [abstract]. Arthritis Rheumatol. 72 (suppl 10). 
Criner GJ, Lang FM, Gottlieb RL, Mathews KS, Wang TS, et al. 2022. Anti-Granulocyte–
Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 
Pneumonia. A Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care 
Med. 205(11): 1290-1299. 
Crommelin HA, van der Burg LM, Vorselaars AD, Drent M, van Moorsel CH, Rijkers GT, 
Deneer VH, Grutters JC. Efficacy of adalimumab in sarcoidosis patients who developed 
intolerance to infliximab. Respir Med. 2016 Jun;115:72-7. doi: 10.1016/j.rmed.2016.04.011. 
Epub 2016 Apr 23. PMID: 27215507. 
Crouser ED, Culver DA, Knox KS, Julian MW, Shao G, et al. 2009. Gene expression profiling 
identifies MMP-12 and ADAMDEC1 as potential pathogenic mediators of pulmonary 
sarcoidosis. Am J Respir Crit Care Med. 179(10):929-938. 
Crouser ED, White P, Caceres EG, Julian MW, Papp AC, et al. 2017. A novel in vitro human 
granuloma model of sarcoidosis and latent tuberculosis infection. Am J Respir Cell Mol Biol. 
57(4):487-498. 
Dougan M, Dranoff G, Dougan SK. 2019. GM-CSF, IL-3, and IL-5 family of cytokines: 
regulators of inflammation. Immunity. 50(4):796-811. 
Drent MD, Elliott D, Crouser MD. Grunewald J. 2021. Challenges of sarcoidosis and its 
management. N Engl J Med. 385:1018-32. DOI: 10.1056/NEJMra2101555. 
Enthammer C, Zambello R, Trentin L, Cerutti A, Milani A, et al. 1993. Synthesis and release of 
granulocyte-macrophage colony-stimulating factor by alveolar macrophages of patients with 
sarcoidosis. Sarcoidosis. 10(2):147-148. 
Gonzalez-Juarrero M, Hattle JM, Izzo A, Junqueira-Kipnis AP, Shim TS, et al. 2005. Disruption 
of granulocyte macrophage-colony stimulating factor production in the lungs severely affects the 
ability of mice to control Mycobacterium tuberculosis infection. J Leukoc Biol. 77(6):914-922. 
Hamilton JA. 2020. GM-CSF in inflammation. J Exp Med. 217(1):e20190945. 
Holland, AE., Spruit, MA., Troosters, T., Puhan, MA., Pepin, V., Saey, D., McCormack, MC., et 
al. (2014). An official European Respiratory Society/American Thoracic Society technical 
standard: field walking tests in chronic respiratory disease. The European respiratory journal, 
44(6), 1428–1446. https://doi.org/10.1183/09031936.00150314 
Hoshino T, Itoh K, Gouhara R, Yamada A, Tanaka Y, et al. 1995. Spontaneous production of 
various cytokines except IL-4 from CD4+ T cells in the affected organs of sarcoidosis patients. 
Clin Exp Immunol. 102(2):399-405. 
Hu Y, Yibrehu B, Zabini D, Kuebler WM. 2017. Animal models of sarcoidosis. Cell Tissue Res. 
367(3):651-661. 
Iannuzzi MC, Rybicki BA, Teirstein AS. 2007. Sarcoidosis. N Engl J Med. 357(21):2153-2165. 
Ishioka S, Saito T, Hiyama K, Haruta Y, Maeda A, et al. 1996. Increased expression of tumor 
necrosis factor-alpha, interleukin-6, platelet-derived growth factor-B and granulocyte- 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 81 
macrophage colony-stimulating factor mRNA in cells of bronchoalveolar lavage fluids from 
patients with sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 13(2):139-145. 
Itoh A, Yamaguchi E, Furuya K, Hizawa N, Ohnuma N, et al. 1993. Correlation of GM-CSF 
mRNA in bronchoalveolar fluid with indices of clinical activity in sarcoidosis. Thorax. 
48(12):1230-1234. 
Itoh A, Yamaguchi E, Furuya K, Kawakami Y. 1998. Secretion of GM-CSF by inflammatory 
cells in the lung of patients with sarcoidosis. Respirology. 3(4):247-251. 
Itoh A, Yamaguchi E, Kuzumaki N, Okazaki N, Furuya K, et al. 1990. Expression of 
Granulocyte-macrophage Colony-stimulating Factor mRNA by inflammatory cells in the sarcoid 
lung. Am J Respir Cell Mol Biol. 3(3):245-249. 
Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status 
for chronic airflow limitation. Am Rev Respir Dis 1992;145;1321-1327 
Judson, M. A., Baughman, R. P., Costabel, U., Flavin, S., Lo, K. H., Kavuru, M. S., Drent, M., & 
Centocor T48 Sarcoidosis Investigators (2008). Efficacy of infliximab in extrapulmonary 
sarcoidosis: results from a randomised trial. The European respiratory journal, 31(6), 1189– 
1196. https://doi.org/10.1183/09031936.00051907 
Khan NA, Donatelli CV, Tonelli AR, Wiesen J, Ribeiro Neto ML, et al. 2017. Toxicity risk from 
glucocorticoids in sarcoidosis patients. Respir Med. 132:9-14. 
Lang FM, Lee KM, Teijaro JR, Becher B, Hamilton JA. 2020. GM-CSF-based treatments in 
COVID-19: reconciling opposing therapeutic approaches. Nat Rev Immunol. 20(8):507-514. 
Lemaire I, Yang H, Lafont V, Dornand J, Commes T, et al. 1996. Differential effects of 
macrophage- and granulocyte-macrophage colony-stimulating factors on cytokine gene 
expression during rat alveolar macrophage differentiation into multinucleated giant cells (MGC): 
role for IL-6 in type 2 MGC formation. J Immunol. 157(11):5118-5225. 
Mehta N, Clark-Bilodeau C, Miller MA, Bourjeily G. Response. Chest. 2020 Jul;158(1):426- 
427. doi: 10.1016/j.chest.2020.02.013. Epub 2020 Jul 2. PMID: 32654719; PMCID: 
PMC8173768. 
Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, et al. 2016. Phase 2, randomised placebo- 
controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in 
patients with inadequately controlled asthma. BMJ Open. Jan 6;6(1):e007709. 
Okamoto H, Mizuno K, Horio T. 2003. Monocyte-derived multinucleated giant cells and 
sarcoidosis. J Dermatol Sci. 31(2):119-128. 
Oltmanns U, Schmidt B, Hoernig S, Witt C, John M. 2003. Increased spontaneous interleukin-10 
release from alveolar macrophages in active pulmonary sarcoidosis. Exp Lung Res. 29(5):315-
328. 
Patel J, Beishuizen A, Ruiz XB, Goughanmi H, Cahn A, et al. 2021. A randomized trial of 
otilimab in severe COVID-19 pneumonia (OSCAR). MedRxiv. 
https://www.medrxiv.org/content/10.1101/2021.04.14.21255475v1 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 82 
Patel AS, Siegert RJ, Creamer D, Larkin G, Maher TM, et al. 2013. The development and 
validation of the king's sarcoidosis questionnaire for the assessment of health status. Thorax. 
Jan;68(1):57-65. 
Patterson KC, Franek BS, Müller-Quernheim J, Sperling AI, Sweiss NJ, et al. 2013. Circulating 
cytokines in sarcoidosis: phenotype-specific alterations for fibrotic and non-fibrotic pulmonary 
disease. Cytokine. 61(3):906-911. 
Piccoli L, Campo I, Fregni CS, Rodriguez BMF, Minola A, et al. Neutralization and clearance of 
GM-CSF by autoantibodies in pulmonary alveolar proteinosis. Nature Communications. 
2015;DOI: 10.1038/ncomms8375. 
Prior C, Knight RA, Herold M, Ott G, Spiteri MA. 1996. Pulmonary sarcoidosis: patterns of 
cytokine release in vitro. Eur Respir J. 9(1):47-53. 
Rangel JR, Chung Y, Rosenbach M, Ziober AF, Zhang PJ, et al. 2014. Expression of Notch 
signaling components in cutaneous foreign body and sarcoidal granulomas and fusing 
macrophages. Am J Dermatopathol. 36(5):409-413. 
Rosen et al. Anti-granulocyte-macrophage colony stimulating factor autoantibodies in patients 
with cryptococcal meningitis J Immunol. 2013 April 15; 190(8): 3959–3966. 
doi:10.4049/jimmunol.1202526 
Rosen Y. Pathology of Granulomatous Pulmonary Diseases. Arch Pathol Lab Med. 2022 Jan 
2;146(2):233-251. doi: 10.5858/arpa.2020-0543-RA. 
Rothchild AC, Stowell B, Goyal G, Nunes-Alves C, Yang Q, et al. 2017. Role of granulocyte- 
macrophage colony-stimulating factor production by T cells during mycobacterium tuberculosis 
infection. mBio. 8(5):e01514-01517. 
Silva E, Souchelnytskyi S, Kasuga K, Eklund A, Grunewald J, et al. 2013. Quantitative intact 
proteomics investigations of alveolar macrophages in sarcoidosis. Eur Respir J. 41(6):1331-39. 
Soto-Gomez N, Peters JI, Nambiar AM. 2016. Diagnosis and Management of Sarcoidosis. Am 
Fam Physician. May 15;93(10):840-8. 
Spagnolo P, Rossi G, Trisolini R, Sverzellati N, Baughman RP, et al. 2018. Pulmonary 
sarcoidosis. Lancet Respir Med. May;6(5):389-402. 
Stenton C. (2008). The MRC breathlessness scale. Occupational medicine (Oxford, England), 
58(3), 226–227. https://doi.org/10.1093/occmed/kqm162 
Tazawa R, Ueda T, Abe M, Tatsumi K, Eda R, Kondoh S, Morimoto K, et al. Inhaled GM-CSF 
for Pulmonary Alveolar Proteinosis. N Engl J Med. 2019 Sep 5;381(10):923-932. doi: 
10.1056/NEJMoa1816216. PMID: 31483963. 
Temesgen Z, Assi M, Shweta FNU, Vergidis P, Rizza SA, et al. 2020. GM-CSF neutralization 
with lenzilumab in severe COVID-19 pneumonia: a case-cohort study. Mayo Clin Proc. 
95(11):2382-2394. 
Temesgen Z, Burger CD, Baker J, Polk C, Libertin CR, et al. 2022. Lenzilumab in hospitalised 
patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo controlled 
trial, Lancet Respir Med. 10: 237-246. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 83 
Valeyre D, Prasse A, Nunes H, Uzunhan Y, Brillet PY, et al. 2014. Sarcoidosis. Lancet. 
383(9923):1155-1167. 
Xing Z, Braciak T, Ohkawara Y, Sallenave JM, Foley R, et al. 1996a. Gene transfer for cytokine 
functional studies in the lung: the multifunctional role of GM-CSF in pulmonary inflammation. J 
Leukoc Biol. 59(4):481-488. 
Xing Z, Ohkawara Y, Jordana M, Graham F, Gauldie J. 1996b. Transfer of granulocyte- 
macrophage colony-stimulating factor gene to rat lung induces eosinophilia, monocytosis, and 
fibrotic reactions. J Clin Invest. 97(4):1102-1110. 
Zhang J, Roberts AI, Liu C, Ren G, Xu G, et al. 2013. A novel subset of helper T cells promotes 
immune responses by secreting GM-CSF. Cell Death Differ. 20(12):1731-1741. 
Ziora D, Jastrzębski D, Adamek M, Czuba Z, Kozielski JJ, et al. 2015. Circulating concentration 
of markers of angiogenic activity in patients with sarcoidosis and idiopathic pulmonary fibrosis. 
BMC Pulm Med. 15:113. 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 84 
10. 
APPENDICES 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 85 
APPENDIX 1: 
SCHEDULE OF ASSESSMENTS 
The Schedule of Assessments for the Double-blind Treatment Period and the Open-label 
Extension Period (OLE) are presented below. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 86 
Schedule of Assessments – Double-blind Treatment Period 
Study Period 
Screen 
Treatment Period 
Follow-upd 
Visit # (V) 
V1 
Baseline 
V2a 
V3a 
 
V4-6b 
V7a 
 
V8-10b 
 
V11a 
 
V12-14b 
V15a 
 
V16-18b 
 
V19a 
 
V20a 
EOT/ ETc 
V21a 
b 
V22 
b 
V23 
EOS 
V24a 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7- 9 
W10 
W11-13 
W14 
W15-17 
W18 W22 
W26 
W30 W34 
W40 
Study Day (D) 
[Window based on Day 1 
visit] 
D -42 to 1 
[+ 3] 
D1 
D15 
[± 3] 
D22, 
D29, D36
[± 3] 
D43 
[± 3] 
D50, 
D57, D64 
[± 3] 
D71 
[± 3] 
D78, 
D85, D92 
[± 3] 
D99 
[± 3] 
D106, 
D113, D120 
[± 3] 
D127 
[± 3] 
D155 
[± 3] 
D183 
[± 3] 
D211 
[± 7] 
D239 
[± 7] 
D281 
[± 7] 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic information 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior medicationse 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examinationf 
X 
X 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
X 
Height and weightg 
X 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
Vital signsh 
(Blood pressure 
[sitting], heart rate, 
respiration rate, and body 
temperature)  
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
X 
12-lead ECGi 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
FDG-PET-High 
resolution CT (HRCT) 
scan j 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
High resolution CT 
(HRCT) scan j 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MRC 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
mKSQ 
 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
SGA 
 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
SGRQ and LCQ 
 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
BSGIC 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 87 
Study Period 
Screen 
Treatment Period 
Follow-upd 
Visit # (V) 
V1 
Baseline 
V2a 
V3a 
 
V4-6b 
V7a 
 
V8-10b 
 
V11a 
 
V12-14b 
V15a 
 
V16-18b 
 
V19a 
 
V20a 
EOT/ ETc 
V21a 
b 
V22 
b 
V23 
EOS 
V24a 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7- 9 
W10 
W11-13 
W14 
W15-17 
W18 W22 
W26 
W30 W34 
W40 
Study Day (D) 
[Window based on Day 1 
visit] 
D -42 to 1 
[+ 3] 
D1 
D15 
[± 3] 
D22, 
D29, D36
[± 3] 
D43 
[± 3] 
D50, 
D57, D64 
[± 3] 
D71 
[± 3] 
D78, 
D85, D92 
[± 3] 
D99 
[± 3] 
D106, 
D113, D120 
[± 3] 
D127 
[± 3] 
D155 
[± 3] 
D183 
[± 3] 
D211 
[± 7] 
D239 
[± 7] 
D281 
[± 7] 
ePOST 
 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
Spirometry (FEV1, 
FEV1/FVC, and FVC)k 
X 
X 
 
 
X 
 
 
 
X 
 
 
X 
X 
 
 
 
DLcok 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Confirm and record steroid 
taper/usel 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications/concurrent 
proceduresm 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serious adverse event 
collection (SAE)n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Non-serious adverse event 
collectionn 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Tuberculosis (TB) test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Viral Screen (Hep B, 
Hep C, HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample for anti-GM- CSF 
auto-antibody 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample for ADA 
(antibodies to study drug)o 
 
X 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
Sample for cytokine and 
chemokine analysesp 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Sample for SAA analysesp 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Sample for SP-D analysisp 
 
X 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
hsCRPp 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 88 
Study Period 
Screen 
Treatment Period 
Follow-upd 
Visit # (V) 
V1 
Baseline 
V2a 
V3a 
 
V4-6b 
V7a 
 
V8-10b 
 
V11a 
 
V12-14b 
V15a 
 
V16-18b 
 
V19a 
 
V20a 
EOT/ ETc 
V21a 
b 
V22 
b 
V23 
EOS 
V24a 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7- 9 
W10 
W11-13 
W14 
W15-17 
W18 W22 
W26 
W30 W34 
W40 
Study Day (D) 
[Window based on Day 1 
visit] 
D -42 to 1 
[+ 3] 
D1 
D15 
[± 3] 
D22, 
D29, D36
[± 3] 
D43 
[± 3] 
D50, 
D57, D64 
[± 3] 
D71 
[± 3] 
D78, 
D85, D92 
[± 3] 
D99 
[± 3] 
D106, 
D113, D120 
[± 3] 
D127 
[± 3] 
D155 
[± 3] 
D183 
[± 3] 
D211 
[± 7] 
D239 
[± 7] 
D281 
[± 7] 
Sample for analysis of other 
sarcoidosis biomarkersp 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
HbA1C 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Clinical laboratory: 
hematology 
X 
X 
X 
 
X 
 
 
 
X 
 
 
X 
X 
 
 
X 
Clinical laboratory: serum 
chemistry 
X 
X 
X 
 
X 
 
 
 
X 
 
 
X 
X 
 
 
X 
Clinical laboratory: 
urinalysis 
X 
X 
X 
 
X 
 
 
 
X 
 
 
X 
X 
 
 
X 
Clinical laboratory: lipids 
X 
X 
X 
 
X 
 
 
 
X 
 
 
X 
X 
 
 
X 
Urine pregnancy test β hCG 
(WCBP only)q 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
PK sampler 
 
X 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Administration of study 
drugs 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
 
 
ADA = anti-drug antibodies, β-hCG = beta human chorionic gonadotropin, BSGIC = Bothersomeness and Subject Global Impression Change, CT = computed tomography, 
DLco = diffusing capacity of the lungs for carbon monoxide, ECG = electrocardiogram, EOS = End-of-Study, EOT = End-of-Treatment, ET = early termination, FEV1 = forced 
expiratory volume in 1 second, FVC = forced vital capacity, FU = Follow-up visit, GM-CSF autoAb = granulocyte macrophage colony- stimulating factor auto-antibody, 
Hep = hepatitis; HIV = human immunodeficiency virus, hsCRP = high-sensitivity C-reactive protein, HRCT = high-resolution CT scan, mKSQ = Modified King’s Sarcoidosis 
Questionnaire, MRC = medical research council, FDG-PET = fluorodeoxyglucose-positron-emission tomography, PK = pharmacokinetics, PRO = Patient Reported Outcomes, 
SAA = serum amyloid A , SC = subcutaneous, SGA = subject global assessment, sIL-2R = soluble IL-2 receptor, SP-D = serum surfactant protein D, SGRQ = St George's 
Respiratory Questionnaire, TB = tuberculosis, 
 = home visit,  = phone call or telemedicine visit. 
a. 
Visits at Week 0, 2, 6, 14, 22, 26 (EOT/ET), and 40 (EOS) will be in the clinic. Visits at Week 10 and 18 can be completed in the clinic or at the subject’s home (in 
applicable countries) with a Sponsor approved home healthcare professional;  
b. 
Visits at Weeks 3-5, 7-9, 11-13, 15-17, 30, and 34 will be conducted via phone or telemedicine. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 89 
c. 
Subjects who withdraw or are withdrawn from the Double-blind Treatment Period of the study early will undergo all Week 26 ET/EOT visit procedures. Subjects who 
continue in the Open-label Extension (OLE) Period will undergo activities specified in the OLE Schedule of Events for the Week 26 visit. 
d. 
For all subjects, regardless of when the subject completes their last dose of study drug, phone call or telemedicine visits will occur approximately 8 weeks and 12 weeks 
following the last dose of study drug; Follow-up visit at approximately 18 weeks following the last dose of study drug will take place in the clinic. 
e. 
Collect medication history from the 6 months leading up to, and including, the time of the Screening Visit, including prescription medications, over-the-counter 
medications, and herbal supplements/vitamins.  In addition, record medication history of any treatments given for pulmonary sarcoidosis in the 2 years prior to screening.  
f. 
A full physical examination (PE) will be performed at screening and the EOT/ET visit; an abbreviated targeted PE will be performed at all remaining clinic visits. 
g. 
Height will be measured at screening only; weight will be measured at all indicated timepoints. 
h. 
Vital signs will be assessed at all timepoints specified above. On study drug administration days, vital signs will be assessed pre-dose (approximately 15 minutes ± 
5 minutes) and approximately 30 minutes (± 5 minutes) post-dose. 
i. 
Single 12-lead standard ECGs will be obtained using Sponsor-provided equipment and read locally using site procedures at all timepoints specified above. 
j. 
Only central imaging interpretation will be accepted for eligibility determination. A PET/HRCT performed as part of clinical care may be used as the screening PET/CT as 
long as the PET/CT is performed within 4 weeks of screening and is uploaded and deemed of acceptable quality by the imaging vendor/central reader. If not of acceptable 
quality for study inclusion, it needs to be obtained again as part of the study inclusion procedures. If the FDG-PET scan does not also have a HRCT included, then a 
separate HRCT must be completed. If HRCT is included as part of FDG-PET, the separate HRCT assessment is not required. 
k. 
On visits at which spirometry and DLco are to be performed, spirometry should be performed first, followed by DLco. 
l. 
Document whether and when the subject has completed taper or whether a dose increase/maintenance was needed. See Appendix 7: Corticosteroid Taper, and Section 6.4: 
Rescue Treatment, for more details. Patients should record OCS dose daily on provided e-diary and Investigator should verify and record OCS use on a weekly basis. If 
the steroid dose is altered from the protocol defined treatment regimen, site should contact the subject to determine if an unscheduled/rescue visit is necessary. 
m. Collect information on concomitant medications and concurrent procedures from the time of randomization through the EOS visit, including prescription medications, 
over-the-counter medications, and herbal supplements/vitamins. All medications and procedures prior to randomization should be listed in subject’s medical history. 
n. 
All serious adverse events (SAEs) will be monitored and collected from the time of informed consent through to the 18-week post last dose of study drug Follow-up visit. 
All adverse events (AEs) will be monitored and collected from the time of first dose through the 18-week post last dose of study drug follow-up visit. Treatment-emergent 
adverse events (TEAEs) will be those that start or change in severity after the first dose of study drug.  
o. 
The ADA samples will be collected at timepoints specified above. If study drug administration occurs at the same visit, the ADA sample will be collected prior to study 
drug administration. For subjects who terminate the study early, an ADA sample will be collected before discharging, when possible. Actual sampling time will be 
recorded. 
p. 
The biomarker samples will be collected prior to study drug administration. See the Laboratory Manual for more details. 
q. 
A negative urine pregnancy test result must be obtained prior to administration of study drug. A positive urine β-hCG test at any time during the study requires immediate 
interruption of study drug and must be followed by a confirmed positive serum β-hCG test. For site visits, urine pregnancy tests will be performed at the site. Urine 
pregnancy tests for phone Follow-up visits may be performed at home and results reported to the Investigator during the follow-up phone calls. The Investigator may 
provide home urine pregnancy kits to the subject where required. 
r. 
The PK samples will be collected prior to study drug administration at the appropriate timepoints; actual sampling time will be recorded. 
s. 
Study drug will be administered on Days as specified above. Subjects will be observed for approximately 30 minutes (± 5 minutes) following the SC injection for adverse 
reactions. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 90 
Schedule of Assessments – Open-label Extension (OLE) Period  
Study Period 
Treatment Period 
Follow-upc 
Visit # (V) 
V21a 
V22 
 
V23a 
 
V24t 
 
V25a 
 
V26t V27a 
 
V28t 
 
V29a 
 
V30a V31a 
EOT/ 
ETb  
V32a 
 
V33t 
 
V34t 
 
EOS 
V35 
Week (W) 
W26d W27e 
W30 
W32 
W34 
W36 
W38 W40 
W42 W46 W50 W54 
W58 
W62 
W68 
Study Day (D) 
[Window based on Day 1 visit] 
D183 
[± 3] 
D188 
[± 1] 
D211 
[± 3] 
D225 
[± 3] 
D239 
[± 3] 
D253 
[± 3] 
D267 
 [± 3] 
D281 
[± 3] 
D295 
[± 3] 
D323 
 [± 3] 
D351 
[± 3] 
D379  
[± 3] 
D407 
[± 7] 
D435 
[± 7] 
D477 
[± 7] 
Confirm eligibility and sign informed consent 
addendumf 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examinationg 
X 
 
 
 
 
 
X 
 
 
X 
 
X 
 
 
X 
Height and weighth 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
Vital signsi 
(blood pressure [sitting], heart rate, respiration rate, and 
body temperature) 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
 
X 
12-lead ECGj 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
SGRQ, mKSQ, SGA, and LCQ 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
BSGIC 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
ePOST 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Spirometry (FEV1, FEV1/FVC, FVC)k 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
DLcok 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Confirm and record steroid taper/usel 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/concurrent proceduresm 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serious adverse event collection (SAE)n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Non-serious adverse event collectionn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Sample for ADA (antibodies to study drug)o 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
Sample for cytokine and chemokine analysesp 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
Sample for SAA analysesp 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 91 
Study Period 
Treatment Period 
Follow-upc 
Visit # (V) 
V21a 
V22 
 
V23a 
 
V24t 
 
V25a 
 
V26t V27a 
 
V28t 
 
V29a 
 
V30a V31a 
EOT/ 
ETb  
V32a 
 
V33t 
 
V34t 
 
EOS 
V35 
Week (W) 
W26d W27e 
W30 
W32 
W34 
W36 
W38 W40 
W42 W46 W50 W54 
W58 
W62 
W68 
Study Day (D) 
[Window based on Day 1 visit] 
D183 
[± 3] 
D188 
[± 1] 
D211 
[± 3] 
D225 
[± 3] 
D239 
[± 3] 
D253 
[± 3] 
D267 
 [± 3] 
D281 
[± 3] 
D295 
[± 3] 
D323 
 [± 3] 
D351 
[± 3] 
D379  
[± 3] 
D407 
[± 7] 
D435 
[± 7] 
D477 
[± 7] 
Sample for SP-D analysisp 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
hsCRPp 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
Sample for analysis of other sarcoidosis biomarkersp 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
HbA1C 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Clinical laboratory: hematology 
X 
 
X 
 
 
 
X 
 
 
X 
 
X 
 
 
X 
Clinical laboratory: serum chemistry 
X 
 
X 
 
 
 
X 
 
 
X 
 
X 
 
 
X 
Clinical laboratory: urinalysis 
X 
 
X 
 
 
 
X 
 
 
X 
 
X 
 
 
X 
Clinical Laboratory: lipids 
X 
 
X 
 
 
 
X 
 
 
X 
 
X 
 
 
X 
Urine pregnancy test β-hCG (WCBP subjects only)q 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
PK sampler 
X 
Xe 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
Administration of study drugs 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
 
 
ADA = anti-drug antibodies, β-hCG = beta human chorionic gonadotropin, BSGIC = Bothersomeness and Subject Global Impression Change, CT = computed tomography, DLco 
= diffusing capacity of the lungs for carbon monoxide, ECG = electrocardiogram, EOS = End-of-Study, EOT = End-of-Treatment, ET = early termination, FEV1 = forced 
expiratory volume in 1 second, FVC = forced vital capacity, FU = Follow-up visit, GM-CSF autoAb = granulocyte macrophage colony- stimulating factor auto-antibody, 
Hep = hepatitis; HIV = human immunodeficiency virus, hsCRP = high sensitivity C-reactive protein, HRCT = high-resolution CT scan, mKSQ = Modified King’s Sarcoidosis 
Questionnaire, FDG-PET = fluorodeoxyglucose positron-emission tomography, PK = pharmacokinetics, PRO = Patient Reported Outcomes, SAA = serum amyloid A, SC = 
subcutaneous, SGA = subject global assessment, sIL-2R = soluble IL-2 receptor, SP-D = serum surfactant protein D, SGRQ = St George's Respiratory Questionnaire, TB = 
tuberculosis, 
 = home visit,  = phone call or telemedicine visit. 
a. 
Visits at Weeks 26, 27, 30, 38, 46, 54 (EOT/ET), and 68 (EOS) will be performed in the clinic. Visits at Weeks 34, 42, and 50 can be completed in the clinic or at the 
subject’s home (in applicable countries) with a Sponsor approved home healthcare professional. 
b. 
Subjects who withdraw or are withdrawn from OLE Period of the study early will undergo all Week 54 ET/EOT visit procedures whenever possible. 
c. 
For all subjects, regardless of when the subject completes their last dose of study drug, phone call or telemedicine visits will occur approximately 8 weeks and 12 weeks 
following the last dose of study drug; Follow-up visit at approximately18 weeks following the last dose of study drug will take place in the clinic. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 92 
d. 
For subjects participating in the OLE Period, only the Week 26 assessments specified in the OLE Schedule of Assessments will be performed; Week 26 assessments will 
not be performed twice. 
e. 
The site should make every effort to have subjects return to the site 5 days after the Week 26 visit for a PK sample. 
f. 
Eligibility will be confirmed by ensuring subjects have completed Week 26 and remained on study drug in order to move forward in the OLE. An informed consent 
addendum should also be completed by all study subjects continuing into the OLE. 
g. 
A full physical examination (PE) will be performed at Week 26 and the ET/EOT visit; an abbreviated targeted PE will be performed at all remaining clinic visits. 
h. 
Height will be measured at screening only; weight will be measured at all indicated timepoints. 
i. 
Vital signs will be assessed at all timepoints specified above. On study drug administration days, vital signs will be assessed pre-dose (approximately 15 minutes ± 
5 minutes) and approximately 30 minutes ± 5 minutes post-dose. 
j. 
Single 12-lead standard ECGs will be obtained using Sponsor-provided equipment and read locally using site procedures at all timepoints specified above. 
k. 
On visits at which spirometry and DLco are to be performed, spirometry should be performed first, followed by DLco. 
l. 
Document whether and when the subject has completed taper or whether a dose increase/maintenance was needed. See Appendix 7: Corticosteroid Taper, and Section 6.4: 
Rescue Treatment, for more details. Patients should record OCS dose daily on provided e-diary and Investigator should verify and record OCS use on a weekly basis. If 
the steroid dose is altered from the protocol defined treatment regimen, site should contact the subject to determine if an unscheduled/rescue visit is necessary. 
m. Collect information on concomitant medications and concurrent procedures from the time of informed consent through the EOS visit, including prescription medications, 
over-the-counter medications, and herbal supplements/vitamins. 
n. 
All serious adverse events (SAEs) will be monitored and collected from the time of informed consent through to the 18-week post last dose of study drug Follow-up visit. 
All adverse events (AEs) will be monitored and collected from the time of first dose through 18 weeks post last dose of study drug. Treatment-emergent adverse events 
(TEAEs) will be those that start or change in severity after the first dose of study drug. 
o. 
The ADA samples will be collected at the timepoints specified above. If study drug administration occurs at the same visit, the ADA sample will be collected prior to 
study drug administration. For subjects who terminate the study early, an ADA sample will be collected before discharging, when possible. Actual sampling time will be 
recorded. 
p. 
The biomarker samples will be collected prior to study drug administration. See the Laboratory Manual for more details. 
q. 
A negative urine pregnancy test result must be obtained prior to administration of study drug. A positive urine β-hCG test at any time during the study requires immediate 
interruption of study drug and must be followed by a confirmed positive serum β-hCG test. For site visits, urine pregnancy tests will be performed at the site. Urine 
pregnancy tests for phone Follow-up visits may be performed at home and results reported to the Investigator during the follow-up phone calls. The investigator may 
provide home urine pregnancy kits to the subject where required. 
r. 
The PK samples will be collected prior to study drug administration at the appropriate timepoints (with the exception of the collection on Day 188 [visit 22]); actual 
sampling time will be recorded 
s. 
A SC injection of study drug 150 mg will be administered on Days as specified above. Subjects will be observed for approximately 30 minutes ± 5 minutes following the 
SC injection for adverse reactions. 
t. 
Visits at Weeks 32, 36, 40, 58 and 62 will be conducted via phone or telemedicine. 
Note: For subjects participating in the OLE Period, only the Week 26 assessments specified in the OLE Schedule of Assessments will be performed; Week 26 assessments will not 
be performed twice. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 93 
APPENDIX 2: 
ADVERSE EVENT DEFINITIONS AND REPORTING 
Definitions 
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. This includes the following: 
• Any clinically significant worsening of a pre-existing condition; 
Note: Emergence of a new pathogen associated with a clinical event during therapy at a 
site other than the initial site of infection will be considered an AE. 
• Any recurrence of a pre-existing condition; 
• An AE occurring from overdose of a Sponsor study drug whether accidental or 
intentional (i.e., a dose higher than that prescribed by a health care professional for 
clinical reasons); 
• An AE occurring from abuse of a Sponsor study drug (i.e., use for nonclinical reasons); 
• An AE that has been associated with the discontinuation of the use of a Sponsor study 
drug. 
Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use 
of study intervention. A procedure is not an AE, but the reason for a procedure may be an AE. 
A pre-existing condition is a clinical condition (including a condition being treated) that is 
diagnosed before the subject signs the Informed Consent Form and that is documented as part of 
the subject’s medical history. 
The questions concerning whether the condition existed before the start of the active phase of the 
study and whether it has increased in severity and/or frequency will be used to determine 
whether an event is a TEAE. An AE is considered to be treatment emergent if: 
1. It is not present when the active phase of the study begins and is not a chronic condition 
that is part of the subject’s medical history; or,  
2. It is present at the start of the active phase of the study or as part of the subject’s medical 
history, but the severity or frequency increases during the active phase. 
The active phase of the study begins at the time of the first dose of the study drug. The active 
phase of the study ends at the Follow-up visit. 
Reporting of Adverse Events 
Non-serious AE reporting begins from the time the first dose of double-blind study drug has 
been taken and ends 18 weeks after the last dose of study drug. 
Serious AE reporting begins from the time of informed consent and ends 18 weeks after the last 
dose of study drug. 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 94 
At each visit the Investigator, or delegate, will determine whether any AEs have occurred. Non-
leading questions such as “How are you feeling today?” or “Have you had any health concerns 
since your last visit?” should be used to elicit the subject to report any possible AEs. If any AEs 
have occurred, they will be recorded in the AE section of the eCRF and in the subject’s source 
documents. If known, the diagnosis should be recorded, in preference to listing the individual 
signs and symptoms. 
Serious Adverse Events 
An SAE is any AE occurring at any dose that meets 1 or more of the following criteria: 
• Results in death; 
• Is life threatening (see below); 
• Requires subject hospitalization or prolongation of an existing hospitalization (see 
below); 
• Results in a persistent or significant disability or incapacity (see below); 
• Results in a congenital anomaly or birth defect; 
• Results in an important medical event, also known as medically significant (see below). 
• Additionally, important medical events that may not result in death, be life threatening, or 
require hospitalization may be considered SAEs when, based on appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed above. Examples of such events 
include allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not require hospitalization, or development 
of drug dependency or drug abuse. 
A life-threatening adverse event is any AE that places the subject at immediate risk of death 
from the event as it occurred. A life-threatening event does not include an event that might have 
caused death had it occurred in a more severe form but that did not create an immediate risk of 
death as it actually occurred. For example, drug-induced hepatitis that resolved without evidence 
of hepatic failure would not be considered life threatening, even though drug-induced hepatitis of 
a more severe nature can be fatal. Hospitalization is to be considered only as an overnight 
admission. 
Hospitalization or prolongation of a hospitalization is a criterion for considering an AE to be 
serious. In the absence of an AE, the participating Investigator should not report hospitalization 
or prolongation of hospitalization. This is the case in the following situations: 
• Hospitalization or prolongation of hospitalization is needed for a procedure required by 
the protocol. Day or night survey visits for biopsy or surgery required by the protocol are 
not considered serious; 
• Hospitalization or prolongation of hospitalization is part of a routine procedure followed 
by the study center (e.g., stent removal after surgery). This should be recorded in the 
study file; 
• Hospitalization for survey visits or annual physicals fall in the same category. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 95 
In addition, a hospitalization planned before the start of the study for a pre-existing condition that 
has not worsened does not constitute an SAE (e.g., elective hospitalization for a total knee 
replacement due to a pre-existing condition of osteoarthritis of the knee that has not worsened 
during the study). 
Disability is defined as a substantial disruption in a person’s ability to conduct normal life 
functions (i.e., the AE resulted in a significant, persistent, or permanent change, impairment, 
damage, or disruption in the subject’s bodily function/structure, physical activities, or quality of 
life). 
Medical and scientific judgment should be exercised in deciding whether a case is serious in 
those situations where important medical events may not be immediately life threatening or 
result in death, hospitalization, disability, or incapacity. These include events that may jeopardize 
the subject or may require medical intervention to prevent one or more outcomes listed in the 
definition of serious. Such events should usually be considered as serious. 
Assessment of Severity 
The Investigator will be asked to provide an assessment of the severity for each AE and SAE 
using the following categories: 
• Mild: Usually transient and may require only minimal treatment or therapeutic 
intervention. The event does not generally interfere with usual activities of daily living. 
• Moderate: Usually alleviated with additional specific therapeutic intervention. The event 
interferes with usual activities of daily living, causing discomfort but poses no significant 
or permanent risk of harm to the subject. 
• Severe: Interrupts usual activities of daily living, significantly affects clinical status, or 
may require intensive therapeutic intervention. 
It is emphasized that the term severe is a measure of severity: thus, a severe AE is not 
necessarily serious. For example, itching for several days may be rated as severe but may 
not be clinically serious. 
Relationship to Study Treatment 
The Investigator will make a determination of the relationship of the AE/SAE to the study drug 
using a four-category system according to the following guidelines: 
• Not related: when the AE is definitely caused by the subject’s clinical state, or the study 
procedure/conditions, or the subject did not receive the drug. 
• Unlikely Related: when the temporal association between the AE and the drug is such 
that the drug is not likely to have any reasonable association with the AE. 
• Possibly Related: when the AE follows a reasonable temporal sequence from the time of 
drug administration but could have been produced by the subject’s clinical state or the 
study procedures/conditions. 
• Definitely Related: when the AE follows a reasonable temporal sequence from 
administration of the drug, abates upon discontinuation of the drug, follows a known or 
hypothesized cause-effect relationship, and (if appropriate) reappears when the drug is 
reintroduced. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 96 
Action Taken for Adverse Events 
The Investigator or designee will record the actions taken for the AE in the eCRF. Actions taken 
will include the following with respect to study drug: 
• Dose not changed: The medication schedule was not changed. 
• Drug interrupted: The medication schedule was modified by temporarily withholding 
the prescribed regimen of medication. 
• Drug withdrawn: The medication schedule was modified through discontinuation of the 
prescribed regimen of medication. 
Follow-up of Adverse Events 
All SAEs that are ongoing at the time of discontinuation, or that develop prior to the final 
Follow-up visit, will be followed for 18 weeks from last study drug administration , or until 
resolution or stabilization. 
Adverse Drug Reactions 
All noxious and unintended responses to an investigational medicinal product (IMP: i.e., where a 
causal relationship between an IMP and an AE is at least a reasonable possibility) related to any 
dose should be considered adverse drug reactions. 
For marketed medicinal products, a response to a drug which is noxious and unintended, and 
which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or 
for modification of physiological function, is to be considered an adverse drug reaction. 
An unexpected adverse drug reaction is defined as an adverse reaction, the nature or severity of 
which is not consistent with the applicable product information (e.g., Investigator’s Brochure for 
an unapproved IMP). 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 97 
APPENDIX 3: 
COMPARISON OF SYSTEMIC GLUCOCORTICOID 
PREPARATIONS 
Glucocorticoids 
Equivalent doses (mg) 
Duration of action (hours) 
Short Acting 
Cortisone acetate 
25 
8 to 12 
Hydrocortisone (cortisol) 
20 
8 to 12 
Intermediate Acting 
Methylprednisolone 
4 
12 to 36 
Prednisolone 
5 
12 to 36 
Prednisone 
5 
12 to 36 
Triamcinolone 
4 
12 to 36 
Long Acting 
Betamethasone 
0.6 
36 to 72 
Dexamethasone 
0.75 
36 to 72 
 
 
(UpToDate, 2022) 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 98 
APPENDIX 4: 
CLINICAL LABORATORY EVALUATIONS 
The following clinical laboratory analytes will be assessed as timepoints specified in the SOA 
(Appendix 1). 
Serum Chemistry 
 
Serology 
- Albumin 
- ALP 
- ALT 
- AST 
- Urea nitrogen (BUN) 
- Calcium (absolute, 
corrected) 
- Creatinine 
- eGFR 
- GGT 
- Glucose 
- LDH 
- Phosphorus 
- Potassium 
- Sodium 
- Chloride 
- Total Bilirubin (total and 
direct) 
- Total CO2 (measured as 
bicarbonate) 
- Total Protein 
- Uric Acid 
- Anti GM-CSF 
- ADAs (to study drug) 
- HBcAb 
- HBsAb 
- HBsAg 
- HCVab 
- Hep B (reflex testing if applicable) 
- Hep C (reflex testing if applicable) 
- HIV Ab 
- RT-PCR (if applicable, based on serology results) 
Hematology 
Urinalysis 
- Hematocrit 
- Hemoglobin 
- MCH 
- MCHC 
- MCV 
- Platelet count 
- RBC 
- Reticulocytes (%, absolute) 
- WBC 
- WBC Differential (%, 
absolute), including: 
o Basophils and 
Eosinophils, 
o Monocytes, 
o Neutrophils, 
Lymphocytes 
- Bilirubin 
- Color and appearance 
- Urine pregnancy test (for WCBP only) 
- Glucose 
- Ketones 
- Leukocyte esterase 
- Microscopic (including RBC and WBC) 
- Nitrate 
- Occult blood 
- pH and specific gravity 
- Protein 
Lipid Profile 
Other Assessments 
- Total cholesterol (TC) 
- Triglycerides (TGs) 
- High-density lipoprotein cholesterol (HDL-C) 
- Low-density lipoprotein cholesterol (LDL-C) 
- HbA1C 
- IGRA (QFT-G) 
Biomarker Assessments 
- Cytokine panel 
- Chemokine panel 
- SAA 
- SP-D  
- sIL-2R 
- hsCRP 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 99 
APPENDIX 5: 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT 
CONSIDERATIONS 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
International Ethical Guidelines; 
• Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) 
Guidelines; 
• The regulation (EU) No. 536/2014 of the European Parliament and the Council of 16 
April 2014 on clinical trials on medicinal products for human use. 
• Applicable laws and regulations. 
The protocol, protocol amendments, Informed Consent Form (ICF), Investigator’s Brochure, and 
other relevant documents (e.g., advertisements) must be submitted to an Institutional Review 
Board (IRB)/Ethics Committee (EC) by the Investigator and reviewed and approved by the 
IRB/EC before the study is initiated.  
• Any substantial modifications to the protocol must be submitted and approved by the 
applicable Regulatory Authorities before implementation.  
• Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an 
immediate hazard to study subjects. 
The Investigator will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB/EC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/EC; 
• Notifying the IRB/EC of serious adverse events or other significant safety findings as 
required by IRB/EC procedures; 
• Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/EC, European 
regulation 536/2014 for clinical studies (if applicable), and all other applicable local 
regulations. 
Finances and Insurance 
Financing and insurance will be addressed in a separate agreement. 
Recruitment and Informed Consent 
Potential participants will be identified by clinical site staff though routine review of patient lists, 
review of patient records, or during patient visits to participating sites. Potential participants may 
also be identified outside of participating clinical sites and referred to study sites through study 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 100 
advertising outreach The exact methods and frequency of study advertising may vary due to 
geography, site preference, and other considerations.  
Prior to starting participation in the study, each subject will be provided with a study specific 
ICF giving details of the study drugs, procedures, and potential risks of the study. Subjects will 
be instructed that they are free to obtain further information from the Investigator (or designee) 
and that their participation is voluntary, and they are free to withdraw from the study at any time. 
Subjects will be given an opportunity to ask questions about the study prior to providing consent 
for participation. 
Subjects will be required to sign a statement of informed consent that meets the requirements of 
local regulations, ICH guidelines, and the IRB/EC or study center, where applicable. The subject 
will be given a copy of the signed ICF, and the original will be maintained with the subject’s 
records. 
Subjects must be re-consented to the most current version of the ICF(s) during their participation 
in the study. 
Subject Data Protection 
Subjects will be assigned a unique identifier and will not be identified by name in electronic 
Case Report Forms (eCRFs), study-related forms, study reports, or any related publications. 
Subject and Investigator personal data will be treated in compliance with all applicable laws and 
regulations. In the event the study protocol, study report, or study data are included in a public 
registry, all identifiable information from individual subjects or Investigators will be redacted 
according to applicable laws and regulations. 
The subject must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the subject and detailed in the informed consent. The subject must also be informed 
that his/her medical records may be examined by Sponsor or Contract Research Organization 
(CRO) auditors or other authorized personnel appointed by the Sponsor, by appropriate IRB/EC 
members, and by inspectors from regulatory authorities, while at the study site. No subject level 
specific identifiers will be sent outside of the study site. 
 
Disclosure 
All information provided regarding the study, as well as all information collected and/or 
documented during the study, will be regarded as confidential. The Investigator (or designee) 
agrees not to disclose such information in any way without prior written permission from the 
Sponsor. 
The Sponsor will submit a summary of the results of the clinical trial together with a summary 
that is understandable to a layperson, where applicable, within 1 year whether results are 
positive, negative, or inconclusive. 
Data Quality Assurance 
The following data quality steps will be implemented: 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 101 
• All subject data relating to the study will be recorded on eCRFs unless directly 
transmitted to the Sponsor or designee electronically (e.g., laboratory data). The 
Investigator is responsible for verifying that data entries are accurate and correct by 
electronically signing the eCRF; 
• The Investigator must maintain accurate documentation (source data) that supports the 
information entered in the eCRF; 
• The Investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents; 
• The Sponsor or designee is responsible for the data management of this study including 
quality checking of the data. Pre-defined, agreed risks, monitoring thresholds, quality 
tolerance thresholds, controls, and mitigation plans will be documented in a risk 
management register. Additional details of quality checking to be performed on the data 
may be included in a Data Management Plan; 
• Study monitors will perform ongoing source data verification to confirm that data entered 
into the eCRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of subjects are being protected; and that the 
study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements; 
• Records and documents, including signed ICFs, pertaining to the conduct of this study 
must be retained by the Investigator in accordance with 21 CFR 312.62(c) (US site) or in 
the study site archive for at least 15 years after completion or discontinuation of the trial 
or at least 2 years after the granting of the last marketing authorization in the European 
Union (when there are no pending or contemplated marketing applications in the EU) or 
for at least 2 years after formal discontinuation of clinical development of the 
investigational product, whatever is the longest; unless local regulations or institutional 
policies require a longer retention period. No records may be destroyed during the 
retention period without the written approval of the Sponsor. No records may be 
transferred to another location or party without written notification to the Sponsor. 
Investigator Documentation Responsibilities 
All individual, subject-specific study data will be entered into a 21 CFR Part 11-compliant EDC 
system on an eCRF in a timely fashion. All data generated from external sources (e.g., central 
laboratory, pharmacokinetics, pharmacodynamics, electrocardiogram, central readers) and 
transmitted to the Sponsor or designee electronically will be integrated with the subject’s eCRF 
data in accordance with the Data Management Plan. 
An eCRF must be completed for each subject who signs an ICF and undergoes any pre-screening 
or screening procedures, according to the eCRF completion instructions. The Sponsor, or CRO, 
will review the supporting source documentation against the data entered into the eCRFs to 
verify the accuracy of the electronic data. The Investigator will ensure that corrections are made 
to the eCRFs and that data queries are resolved in a timely fashion by the study staff. 
The Investigator will sign and date the eCRF via the EDC system’s electronic signature 
procedure. These signatures will indicate that the Investigator reviewed and approved the data on 
the eCRF, the data queries, and the site notifications. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 102 
Publications 
If, on completion of the study, the data warrant publication, the Investigator may publish the 
results in recognized (refereed) scientific journals subject to the provisions of the clinical study 
agreement (CSA). Unless otherwise specified in the CSA, the following process shall occur: 
The institution and Investigator shall not publish or present data from an individual study center 
until the complete multicenter study has been presented in full or for 2 years after the termination 
of the multicenter study, whichever occurs first. Subsequent publications must refer to the 
multicenter findings. Thereafter, if the Investigator expects to participate in the publication of 
data generated from this site, the institution and Investigator shall submit reports, abstracts, 
manuscripts, and/or other presentation materials to the Sponsor for review before submission for 
publication or presentation. The Sponsor shall have 60 days to respond with any requested 
revisions, including (without limitation) the deletion of confidential information. The 
Investigator shall act in good faith upon requested revisions, except the Investigator shall delete 
any confidential information from such proposed publications. The Investigator shall delay 
submission of such publication or presentation materials for up to an additional 90 days to have a 
patent application(s) filed. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 103 
APPENDIX 6: 
LIVER SAFETY SUGGESTED ACTIONS AND 
FOLLOW-UP ASSESSMENTS 
Phase II liver function stopping criteria are designed to ensure subject safety and to evaluate liver 
event etiology. 
Appendix 6.1: 
Phase II Liver Function Stopping Criteria and Follow-up Assessments 
Liver Function Stopping Criteria 
ALT-absolute 
ALT ≥ 5×ULN 
ALT Increase 
ALT ≥ 3×ULN persists for ≥ 4 weeks 
Bilirubin1,2 
ALT ≥ 3×ULN and bilirubin ≥ 2xULN (> 35% direct bilirubin) 
INR2 
ALT ≥ 3×ULN and INR > 1.5 (if INR measured) 
Cannot Monitor 
ALT ≥ 3×ULN and cannot be monitored weekly for 4 weeks 
Symptomatic3 
ALT ≥ 3×ULN associated with symptoms (new or worsening) believed to 
be related to liver injury or hypersensitivity 
 
Actions and Follow-up Assessments Following ANY Liver Function Event that Requires Study 
Treatment Discontinuation 
Actions 
Follow-Up Assessments 
• 
Immediately discontinue study treatment. 
• 
Report the event to the Sponsor immediately 
without exceeding 24 hours. 
• 
Complete the liver event eCRF and complete an 
SAE data collection tool if the event also met the 
criteria for an SAE.2 
• 
Perform liver function follow-up assessments. 
• 
Monitor the subject until liver function test 
abnormalities resolve, stabilize, or return to 
baseline (see MONITORING). 
• 
Do not restart/rechallenge subject with study 
treatment unless allowed per protocol and 
Sponsor Medical Governance approval is 
granted. 
o If restart/rechallenge not granted, 
permanently discontinue study treatment 
and may continue subject in the study for 
any protocol specified follow up 
assessments. 
• 
Viral hepatitis serology.4 
• 
Blood sample for pharmacokinetic (PK) 
analysis obtained after the most recent 
dose.5 
• 
Serum creatine phosphokinase (CPK) and 
lactate dehydrogenase (LDH) 
• 
Fractionate bilirubin if total bilirubin is 
≥ 2×ULN 
• 
Complete blood count with differential to 
assess eosinophilia 
• 
Record the appearance or worsening of 
clinical symptoms of liver injury, or 
hypersensitivity, on the AE report form 
• 
Record use of concomitant medications 
(including acetaminophen, herbal 
remedies, and other over-the-counter 
medications) on the concomitant 
medications report form. 
• 
Record alcohol use on the liver event 
alcohol intake eCRF. 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 104 
Actions and Follow-up Assessments Following ANY Liver Function Event that Requires Study 
Treatment Discontinuation 
Actions 
Follow-Up Assessments 
MONITORING: 
For bilirubin or INR criteria: 
• 
Repeat liver function tests (include ALT, AST, 
alkaline phosphatase, bilirubin) and perform liver 
function follow-up assessments within 24 hrs. 
• 
Monitor subject twice weekly until liver function 
test abnormalities resolve, stabilize, or return to 
baseline. 
• 
A specialist or hepatology consultation is 
recommended. 
For All other criteria: 
• 
Repeat liver function tests (include ALT, AST, 
alkaline phosphatase, bilirubin) and perform liver 
function follow-up assessments within 24 to 
72 hours. 
• 
Monitor subjects weekly until liver function 
abnormalities resolve, stabilize, or return to 
baseline. 
For bilirubin or INR criteria: 
• 
Anti-nuclear antibody, anti-smooth muscle 
antibody, Type 1 anti-liver kidney 
microsomal antibodies, and quantitative 
total immunoglobulin G (IgG) or gamma 
globulins. 
• 
Serum acetaminophens adduct HPLC assay 
(quantifies potential acetaminophen 
contribution to liver injury in subjects with 
definite or likely acetaminophen use in the 
preceding week. 
• 
Liver imaging (ultrasound, magnetic 
resonance, or computerized tomography) 
and/or liver biopsy to evaluate liver 
disease; complete Liver Imaging and/or 
Liver Biopsy eCRFs. 
1. Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation is 
not immediately available, discontinue study treatment if ALT ≥ 3×ULN and bilirubin ≥ 2×ULN. 
Additionally, if serum bilirubin fractionation testing is unavailable, record the absence/presence of 
detectable urinary bilirubin on dipstick which is indicative of direct bilirubin elevations suggesting liver 
injury. 
2. All events of ALT ≥ 3×ULN and bilirubin ≥ 2×ULN (> 35% direct bilirubin) or ALT ≥ 3×ULN and INR > 
1.5 may indicate severe liver injury (possible ‘Hy’s Law’) and must be reported as an SAE (excluding 
studies of hepatic impairment or cirrhosis). The INR measurement is not required, and the stated threshold 
value will not apply to subjects receiving anticoagulants. 
3. New or worsening symptoms believed to be related to liver injury (such as fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness, or jaundice) or hypersensitivity (such as fever, rash or eosinophilia). 
4. Includes: Hepatitis A IgM antibody; hepatitis B surface antigen and hepatitis B Core Antibody (HBcAb); 
hepatitis C RNA; cytomegalovirus IgM antibody; Epstein-Barr viral capsid antigen IgM antibody (or if 
unavailable, heterophile antibody or monospot testing); and hepatitis E IgM antibody. 
5. PK sample may not be required for subjects known to be receiving placebo or non-comparator treatments. 
Record the date/time of the PK blood sample draw and the date/time of the last dose of study treatment prior 
to the blood sample draw on the eCRF. If the date or time of the last dose is unclear, provide the subject’s 
best approximation. If the date/time of the last dose cannot be approximated OR a PK sample cannot be 
collected in the time period indicated above, do not obtain a PK sample. Instructions for sample handling and 
shipping are in the laboratory manual. 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 105 
Appendix 6.2: 
Phase II Liver Function Increased Monitoring Criteria with 
Continued Therapy 
Liver Function Increased Monitoring Criterion and Follow-up 
Criteria 
Actions 
• 
ALT ≥ 3×ULN and < 5×ULN and 
bilirubin < 2×ULN, without 
symptoms believed to be related to 
liver injury or hypersensitivity, and 
who can be monitored weekly for 
4 weeks 
• 
Notify the Sponsor Medical Monitor immediately 
without exceeding 24 hours of learning of the 
abnormality to discuss subject safety. 
• 
Subject can continue study treatment 
o Subject must return weekly for repeat liver 
function tests (ALT, AST, alkaline phosphatase, 
bilirubin) until the abnormalities resolve, 
stabilize, or return to baseline. 
• 
If at any time, the subject meets liver function stopping 
criteria, proceed as previously described. 
o If, after 4 weeks of monitoring, ALT < 3×ULN 
and bilirubin < 2×ULN, monitor subjects twice 
monthly until liver function tests normalize or 
return to baseline. 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 106 
APPENDIX 7: 
ORAL CORTICOSTEROID TAPER 
Double-blind Period 
If a subject begins with a baseline dose of > 10 mg/day prednisone or equivalent, this dose will 
be reduced to 10 mg/day or less by the end of Week 6. The dose will then be reduced further to 
5 mg/day or less by the end of Week 10. 
If a subject begins with a baseline dose of ≤ 10 mg/day prednisone or equivalent, this dose will 
be reduced to 5 mg/day or less by the end of Week 6, as indicated in Table 7. 
Table 7. 
Corticosteroid Taper Schedule Double-Blind Period 
Baseline Dose 
Week 0-6 
Week 7-10 
Week 11-18 
11-25 mg/day 
Goal ≤ 10 mg/day by end 
of Week 6 
Goal ≤ 5 mg/day by end 
of Week 10 
Goal 0 mg/day by 
Week 18 if possible*  
6-10 mg/day 
Goal ≤ 5 mg/day by end 
of Week 6 
Goal 0 mg/day by end of 
Week 10 if possible* 
Maintain 0 mg/day if 
possible*  
* A taper below 5 mg should be initiated, depending on the subject’s status and the judgment of the Investigator. 
The taper may be stopped at any point between 5 and 0 mg/day in the judgment of the Investigator. If the taper is 
stopped between 5 and 0 mg/day, the Investigator must document the reason in the source documents. 
Investigators will determine the specific incremental tapering schedule to achieve the above 
goals by the specified timepoints. The Investigator will conduct weekly follow-up visits (via 
phone, telemedicine or any site approved remote method) to ensure proper tapering of OCS and 
document in the eCRF. The subjects will record daily steroid usage in an eDiary and the 
Investigator should verify and record OCS use on a weekly basis. If the steroid dose is altered 
from the protocol defined treatment regimen, site should contact the subject to determine if an 
unscheduled visit/rescue visit is necessary. 
If a subject tapers to a dose of 5 mg/day prednisone or equivalent in the timeframes given in 
Table 7, then the subject is considered to have successfully completed the taper. The Investigator 
will then determine whether to continue the taper below 5 mg/day, although this is not required. 
If a subject substantially deteriorates during the taper period in the opinion of the Investigator, 
then a “rescue” may be performed (see Section 6.4). In this scenario, the steroid dose may be 
maintained or increased back to a prior level, and the subject is considered to have failed the 
steroid taper. Steroid taper may be recommenced after assessing clinical response to the rescue 
treatment. 
After increasing the OCS doses for an intercurrent illness, the patient should have the dose of 
OCS returned to the pre-illness dose within 14 days.  
Open-Label Extension Period 
A subject enrolling in the OLE Period of the trial may be on OCS and/or ISTs that may have 
been added for rescue treatment in the Double-blind Treatment Period. In the OLE, starting at 
Week 30, efforts should be made to taper/remove OCS and ISTs. Taper of OCS to ≤ 5 mg/day 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 107 
and removal of IST should be completed by Week 38 and if feasible, taper of OCS to 0 mg/day 
by Week 42 (Table 8). 
Table 8. 
Corticosteroid Taper Schedule Open-Label Extension Period 
* A taper below 5 mg should be initiated, depending on the subject’s status and the judgment of the Investigator. 
The taper may be stopped at any point between 5 and 0 mg/day in the judgment of the Investigator. If the taper is 
stopped between 5 and 0 mg/day, the Investigator must document the reason in the source documents. 
 
 
Week 26-30 
Week 30-38 
Week 39-42 
If on OCS, maintain current dose 
Goal OCS ≤ 5 mg/day by end of 
Week 38 if possible* 
Goal OCS 0 mg/day by 
Week 42 if possible* 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 108 
APPENDIX 8: 
PATIENT REPORTED OUTCOMES ASSESSMENTS 
Appendix 8.1: 
St. George’s Respiratory Questionnaire (SGRQ) 
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE ORIGINAL ENGLISH VERSION 
 
This questionnaire is designed to help us learn much more about how your 
breathing is troubling you and how it affects your life. We are using it to find out 
which aspects of your illness cause you the most problems, rather than what the 
doctors and nurses think your problems are. 
 
Please read the instructions carefully and ask if you do not understand anything. 
Do not spend too long deciding about your answers. 
 
 
Before completing the rest of the questionnaire: 
 
Please check one box to show how you describe 
your current health: 
Very 
good 
 
Good 
 
Fair 
 
Poor 
 
 
 
Very 
poor 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 109 
St. George’s Respiratory Questionnaire 
PART 1 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 110 
St. George’s Respiratory Questionnaire 
PART 2 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 111 
St. George’s Respiratory Questionnaire 
PART 2 (continued) 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 112 
St. George’s Respiratory Questionnaire 
PART 2 (concluded) 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 113 
St. George’s Respiratory Questionnaire 
 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 114 
Appendix 8.2: 
Modified King’s Sarcoidosis Questionnaire (mKSQ) 
This questionnaire is designed to assess the impact of sarcoidosis on various aspects of your life. 
Read each question carefully and answer by SELECTING the response that best applies to you. 
Please answer ALL questions as honestly as you can. This questionnaire is confidential. 
All questions relate to how SARCOIDOSIS has affected your health. 
GENERAL HEALTH STATUS 
In the last 2 weeks... 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the time 
1 
I have felt frustrated 
1 
2 
3 
4 
5 
6 
7 
2 
I have had trouble concentrating 
1 
2 
3 
4 
5 
6 
7 
3 
I have lacked motivation 
1 
2 
3 
4 
5 
6 
7 
4 
I have felt tired 
1 
2 
3 
4 
5 
6 
7 
5 
I have felt anxious 
1 
2 
3 
4 
5 
6 
7 
6 
I have felt aches and pains in my muscles/joints 
1 
2 
3 
4 
5 
6 
7 
7 
I have felt embarrassed 
1 
2 
3 
4 
5 
6 
7 
8 
I have worried about my weight 
1 
2 
3 
4 
5 
6 
7 
9 
I have worried about my sarcoidosis 
1 
2 
3 
4 
5 
6 
7 
 
In the last 2 weeks... 
A huge amount 
A considerable amount 
A moderate amount 
A modest amount 
A small amount 
A tiny amount 
None at all 
10 Tiredness has interfered with my normal social 
activities such as going out with friends/family 
1 
2 
3 
4 
5 
6 
7 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 115 
LUNGS 
In the last 2 weeks... 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the time 
None of the time 
11 My cough has caused pain/discomfort 
1 
2 
3 
4 
5 
6 
7 
12 I have been breathless climbing stairs or 
walking up slight inclines 
1 
2 
3 
4 
5 
6 
7 
13 I have had to take deep breaths, also known as ‘air 
hunger’ 
1 
2 
3 
4 
5 
6 
7 
14 My chest has felt tight 
1 
2 
3 
4 
5 
6 
7 
15 I have had episodes of breathlessness 
1 
2 
3 
4 
5 
6 
7 
16 I have experienced chest pains 
1 
2 
3 
4 
5 
6 
7 
17 I have been breathless walking on level ground 
1 
2 
3 
4 
5 
6 
7 
18 I have had a wheeze or whistling sound from my 
chest 
1 
2 
3 
4 
5 
6 
7 
19 I have had trouble breathing 
1 
2 
3 
4 
5 
6 
7 
20 
I have had to clear phlegm (sputum) from my chest 
1 
2 
3 
4 
5 
6 
7 
21 My cough has been intense 
1 
2 
3 
4 
5 
6 
7 
22 My cough has disturbed my sleep 
1 
2 
3 
4 
5 
6 
7 
23 My sleep has been disturbed by breathlessness 
1 
2 
3 
4 
5 
6 
7 
24 I have had coughing bouts during the night  
1 
2 
3 
4 
5 
6 
7 
25 I have had coughing bouts during the daytime 
(awake hours only) 
1 
2 
3 
4 
5 
6 
7 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 116 
MEDICATION 
In the last 2 weeks... 
A huge amount 
A considerable amount 
A moderate amount 
A modest amount 
A small amount 
A tiny amount 
None at all 
26 I have worried about the side effects of 
my medication for sarcoidosis 
1 
2 
3 
4 
5 
6 
7 
27 I have felt worse because of my medication 
1 
2 
3 
4 
5 
6 
7 
28 I have gained weight because of my medication 
1 
2 
3 
4 
5 
6 
7 
 
SKIN 
In the last 2 weeks... 
A huge amount 
A considerable amount 
A moderate amount 
A modest amount 
A small amount 
A tiny amount 
None at all 
29 I have been bothered by my skin problems 
1 
2 
3 
4 
5 
6 
7 
30 I have been concerned about changes in the 
color of my skin lesions 
1 
2 
3 
4 
5 
6 
7 
In the last 2 weeks... 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time
None of the time 
31 I have been embarrassed about my skin 
1 
2 
3 
4 
5 
6 
7 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 117 
EYES 
In the last 2 weeks... 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the time 
None of the time 
32 I have had dry eyes 
1 
2 
3 
4 
5 
6 
7 
33 I have had difficulty with bright lights 
1 
2 
3 
4 
5 
6 
7 
34 My eyes have been red 
1 
2 
3 
4 
5 
6 
7 
35 I have had pain in/or around the eyes 
1 
2 
3 
4 
5 
6 
7 
36 I have had difficulty reading 
1 
2 
3 
4 
5 
6 
7 
 
In the last 2 weeks... 
A huge amount 
A considerable amount 
A moderate amount 
A modest amount 
A small amount 
A tiny amount 
None at all 
37 I have had blurred vision 
1 
2 
3 
4 
5 
6 
7 
38 I have been worried about my eyesight 
1 
2 
3 
4 
5 
6 
7 
Dr SS Birring Copyright KSQ. V8 (2010) 
KSQ (United States-English) 01MAY2019 FINAL 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 118 
Appendix 8.3: 
Subject Global Assessment (SGA) 
Frequency 
Over the last two weeks, please rate how frequently you experienced sarcoidosis lung symptoms 
(coughing, breathlessness, and chest pain/tightness): 
 
None of the 
time 
A little of the time 
Some of the 
time 
Most of the time 
All of the time 
☐ 
☐ 
☐ 
☐ 
☐ 
 
Severity 
Over the last two weeks, please rate how severe your sarcoidosis lung symptoms (coughing, 
breathlessness and chest pain/tightness) have been: 
 
None 
Mild 
Moderate 
Severe 
Very Severe 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 119 
Appendix 8.4: 
Leicester Cough Questionnaire (LCQ) 
LEICESTER COUGH QUESTIONNAIRE 
This questionnaire is designed to assess the impact of your cough on various aspects of your life. Read each question carefully and answer by 
CIRCLING the response that best applies to you. Please answer ALL questions, as honestly as you can.  
1. 
In the last 2 weeks, have you had chest or stomach pains as a result of your cough? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
2. 
In the last 2 weeks, have you been bothered by phlegm production when you cough? 
 
1 
2 
3 
4 
5 
6 
7 
 
Every time 
Most times 
Several times 
Sometimes 
Occasionally 
Rarely 
Never 
3. 
In the last 2 weeks, have you been tired because of your cough? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
4. 
In the last 2 weeks, have you felt in control of your cough? 
 
1 
2 
3 
4 
5 
6 
7 
 
None of the time 
Hardly any of the 
A little of the time 
Some of the time 
A lot of the time 
Most of the time 
All of the time 
5. 
How often during the last 2 weeks have you felt embarrassed by your coughing? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 120 
6. 
In the last 2 weeks, my cough has made me feel anxious 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
7. 
In the last 2 weeks, my cough has interfered with my job, or other daily tasks 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
8. 
In the last 2 weeks, I felt that my cough interfered with the overall enjoyment of my life 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
9. 
In the last 2 weeks, exposure to paints or fumes has made me cough 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
10. In the last 2 weeks, has your cough disturbed your sleep? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
11. In the last 2 weeks, how many times a day have you had coughing fits? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
(continuously) 
Most times during 
the day 
Several times during 
the day 
Sometimes during 
the day 
Occasionally through 
the day 
Rarely 
None 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 121 
12. In the last 2 weeks, my cough has made me feel frustrated 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
13. In the last 2 weeks, my cough has made me feel fed up 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
14. In the last 2 weeks, have you suffered from a hoarse voice as a result of your cough? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
15. In the last 2 weeks, have you had a lot of energy? 
 
1 
2 
3 
4 
5 
6 
7 
 
None of the time 
Hardly any of the 
time 
A little of the time 
Some of the time 
A lot of the time 
Most of the time 
All of the time 
16. In the last 2 weeks, have you worried that your cough may indicate a serious illness? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
17. In the last 2 weeks, have you been concerned that other people think something is wrong with you because of your cough? 
 
1 
2 
3 
4 
5 
6 
7 
 
All of the time 
Most of the time 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 122 
18. In the last 2 weeks, my cough has interrupted conversations or telephone calls 
 
1 
2 
3 
4 
5 
6 
7 
 
Every time 
Most times 
A lot of the time 
Some of the time 
A little of the time 
Hardly any of the 
time 
None of the 
time 
19. In the last 2 weeks, I feel that my cough has annoyed my partner, family or friends 
 
1 
2 
3 
4 
5 
6 
7 
 
Every time I cough Most times when 
I cough 
Several times when 
I cough 
Sometimes when 
I cough 
Occasionally when 
I cough 
Rarely 
Never 
Thank you for completing this questionnaire. 
 
 
 
 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 123 
Appendix 8.5: 
Bothersomeness and Subject Global Impression of Change (BSGIC) 
The assessment of Bothersomeness and Subject Global Impression of Change is a tool to assess 
of the qualitative impact of your sarcoidosis on your worst, or most bothersome symptoms that 
you have, and the perceived overall impact of the randomized treatment allocation to your 
disease after 26 weeks of therapy. 
At baseline, please identify which symptom is the most bothersome in your daily life: 
1. Breathlessness. 
2. Fatigue, tiredness, or lack of energy. 
3. Disturbed Sleep. 
4. Cough. 
5. Pain (any location). 
Please rate your worst symptom on a 100 mm linear VAS from 0 mm - not bothersome at all (no 
impact at all to activities of your daily life), to 100 mm being the most bothersome imaginable 
(severely impacting all aspects of your daily life). 
 
At the final assessment at Week 26 (or withdrawal/ early termination); you will be reminded of 
your most bothersome symptom (but not your Baseline score); please re-rate based on your end 
of study symptoms. 
Your Baseline Most Bothersome Symptom was __________________________. 
Please re-rate from 0 mm - not bothersome at all (no impact at all to activities of your daily life), 
to 100 mm being the most bothersome imaginable (severely impacting all aspects of your daily 
life). 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 124 
Please rate your overall impression based on the totality of the treatment you received (i.e., the 
total effect of the blinded study medication plus the effect of oral steroids and the steroid taper, 
stopping other immune therapies, and any rescue medication for sarcoidosis you received. 
Since you started your study medication, how have your sarcoidosis lung symptoms (coughing, 
breathlessness and/or chest pain/tightness) changed? 
 
Much 
Improved 
Moderately 
Improved 
Minimally 
Improved 
No Change Minimally 
Worse 
Moderately 
Worse 
Much Worse 
☐ 
☐ 
☐ 
☐ 
☐ 
☐ 
☐ 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 125 
APPENDIX 9: 
CLINICIAN REPORTED OUTCOME 
Appendix 9.1: 
Extrapulmonary Physician Organ Severity Tool (EPOST) 
 
 

Clinical Protocol KIN-1902-2001 
Kinevant Sciences GmbH 
Version 3.0 (Amendment 2) 
13-May-2024 
Confidential 
Page 126 
APPENDIX 10: 
THE MEDICAL RESEARCH COUNCIL 
BREATHLESSNESS SCALE 
The MRC Breathlessness Scale is to be used to ensure at least minimal dyspnea in the subjects 
taking part in the study (see inclusion #8, Section 4.1). The scale consists of 5 levels of perceived 
breathlessness based on different physical activity: its categories range from 1-5 as shown below 
(Stenton, 2008). 
Subjects must report 2 or above at screening to be eligible. 
1 
Not troubled by breathlessness except on strenuous exercise 
2 
Short of breath when hurrying on the level or walking up a slight hill 
3 
Walks slower than most people on the level, stops after a mile or so, or stops after 15 minutes 
walking at own pace 
4 
Stops for breath after walking about 100 yards or after a few minutes on level ground 
5 
Too breathless to leave the house, or breathless when undressing 
 

Signature Page for KIN-1902-2001 Protocol Amendment 2 1.0
Signature Page for VV-CLIN-001518 v1.0
Approval Task
16-May-2024 12:58:23 GMT+0000
PPD