Conditions: Sarcoidosis, Cardiac
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: yes

Brief summary:
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.

Detailed description:
Study was terminated after a single participant had received 2 doses.

Arms:
arm 1: A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.

Interventions: intervention 1: Namilumab
Intervention descriptions: intervention 1: Specified dose on specified days

Protocol document:
Prot_SAP_000.pdf: 
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CLINICAL STUDY PROTOCOL 
Study Title: 
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study 
with an Open-label Cohort to Assess the Safety, Tolerability, and 
Efficacy of Namilumab in Subjects with Active Cardiac Sarcoidosis 
Protocol Number: 
KIN-1902-2002 
Protocol Name: 
RESOLVE - Heart 
Compound Name 
and/or Number: 
Namilumab 
Sponsor: 
Kinevant Sciences GmbH 
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: 
2a 
Indication: 
Cardiac Sarcoidosis 
Current Version and 
Effective Date: 
Version 2.0 (Amendment 1): 14-April-2022 
Study Director: 
 
Telephone: 
 
Email: 
 
NCT #: NCT05351554
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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The information contained in this document, particularly unpublished data, is the property or 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 studies of the investigational drug described in the protocol. 
You will not disclose any of the information to others without written authorization from the 
Sponsor, except to the extent necessary to obtain informed consent from those persons to whom 
the drug may be administered. 
 


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INVESTIGATOR SIGNATURE PAGE 
Study Title:  A Randomized, Double-blind, Placebo-controlled, Phase 2a Study with an 
Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects 
with Active Cardiac Sarcoidosis 
 
Protocol Number:  KIN-1902-2002 
 
• I confirm agreement to conduct the study in compliance with the protocol and 
International Conference on Harmonisation-Good Clinical Practice (ICH/GCP) 
guidelines; 
• 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 
 
 
 


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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
SPONSOR SIGNATURE PAGE ....................................................................................................3 
INVESTIGATOR SIGNATURE PAGE .........................................................................................4 
TABLE OF CONTENTS .................................................................................................................5 
LIST OF TABLES .........................................................................................................................10 
LIST OF FIGURES .......................................................................................................................10 
PROTOCOL SYNOPSIS...............................................................................................................11 
LIST OF ABBREVIATIONS ........................................................................................................21 
1. 
INTRODUCTION ......................................................................................................25 
1.1. 
Study Rationale ...........................................................................................................25 
1.2. 
Background .................................................................................................................25 
1.3. 
Benefit-risk Assessment .............................................................................................28 
2. 
OBJECTIVES AND ENDPOINTS ............................................................................33 
2.1. 
Objectives ...................................................................................................................33 
2.2. 
Endpoints ....................................................................................................................33 
3. 
INVESTIGATION PLAN ..........................................................................................34 
3.1. 
Overall Study Design and Plan Description ...............................................................34 
3.1.1. 
Screening Period .........................................................................................................36 
3.1.2. 
34-week Treatment Period ..........................................................................................36 
3.1.3. 
Follow-up Period ........................................................................................................36 
3.1.4. 
Unscheduled Visits .....................................................................................................37 
3.1.4.1. 
Rescue Visit ................................................................................................................37 
3.2. 
Discussion of Study Design, Including the Choice of Control Group .......................37 
3.3. 
End of Study Definition ..............................................................................................37 
3.4. 
Selection of Doses in the Study ..................................................................................37 
4. 
SELECTION OF STUDY POPULATION ................................................................38 
4.1. 
Inclusion Criteria ........................................................................................................38 
4.2. 
Exclusion Criteria .......................................................................................................39 
4.3. 
Disease Diagnostic Criteria ........................................................................................41 
4.4. 
Discontinuation Criteria ..............................................................................................41 
4.4.1. 
Screen Failures ............................................................................................................41 


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4.4.2. 
Discontinuation of Study Treatment ...........................................................................41 
4.4.2.1. 
Permanent Cessation of Study Drug ...........................................................................41 
4.4.2.2. 
Temporary Cessation of Study Drug ..........................................................................42 
4.4.2.3. 
Participant Discontinuation/Withdrawal of Consent ..................................................42 
4.4.2.4. 
Liver Injury .................................................................................................................43 
4.4.2.5. 
Cardiac Changes .........................................................................................................44 
4.4.2.6. 
Pregnancy ...................................................................................................................45 
4.4.3. 
Lost to Follow-up .......................................................................................................45 
4.4.4. 
Subject Replacement ..................................................................................................45 
4.5. 
Study Termination ......................................................................................................45 
4.5.1. 
Early Termination of the Study ..................................................................................45 
4.5.2. 
Early Termination of a Study Center ..........................................................................46 
5. 
STUDY TREATMENTS ............................................................................................46 
5.1. 
Treatments Administered ............................................................................................47 
5.2. 
Preparation, Storage, Handling, and Accountability ..................................................47 
5.2.1. 
Return of Study Drug ..................................................................................................48 
5.2.2. 
Destruction of Study Drug ..........................................................................................48 
5.3. 
Treatment Assignment and Administration ................................................................48 
5.3.1. 
Dose Modification ......................................................................................................48 
5.4. 
Blinding ......................................................................................................................49 
5.5. 
Treatment Compliance ................................................................................................49 
5.5.1. 
Study Drug Compliance .............................................................................................49 
5.5.2. 
Corticosteroid Use and Taper Compliance .................................................................49 
6. 
CONCOMITANT THERAPIES AND OTHER RESTRICTIONS ...........................49 
6.1. 
Concomitant Therapy .................................................................................................49 
6.2. 
Prohibited Medications/Therapies ..............................................................................50 
6.3. 
Contraception ..............................................................................................................50 
6.4. 
Rescue Therapy ..........................................................................................................52 
7. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................52 
7.1. 
Efficacy Assessments .................................................................................................53 
7.1.1. 
Cardiac Testing ...........................................................................................................53 
7.1.1.1. 
Transthoracic Echocardiography ................................................................................53 


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7.1.1.2. 
Wearable Device for Arrhythmia Assessment ...........................................................55 
7.1.2. 
Radiographic Assessments .........................................................................................55 
7.1.2.1. 
[18-F] Fluorodeoxyglucose-Positron Emission Tomography/Computed 
Tomography ................................................................................................................56 
7.1.3. 
Patient-reported Outcomes .........................................................................................57 
7.1.3.1. 
King’s Sarcoidosis Questionnaire ...............................................................................58 
7.1.3.2. 
Fatigue Assessment Scale ...........................................................................................58 
7.1.3.3. 
Subject Global Assessment .........................................................................................58 
7.1.4. 
Other Reported Outcomes ..........................................................................................58 
7.1.4.1. 
Modified Glucocorticoid Toxicity Index ....................................................................59 
7.2. 
Safety Assessments .....................................................................................................59 
7.2.1. 
Vital Signs, Height, and Body Weight .......................................................................59 
7.2.1.1. 
Vital Signs ..................................................................................................................59 
7.2.1.2. 
Height .........................................................................................................................59 
7.2.1.3. 
Body Weight ...............................................................................................................59 
7.2.2. 
Physical Examinations ................................................................................................60 
7.2.3. 
Electrocardiograms .....................................................................................................60 
7.2.4. 
Chest Radiography ......................................................................................................60 
7.2.5. 
Spirometry ..................................................................................................................60 
7.2.6. 
Tuberculosis Screening ...............................................................................................61 
7.2.7. 
HIV and Hepatitis Screening ......................................................................................61 
7.2.8. 
Clinical Safety Laboratory Assessments ....................................................................61 
7.2.9. 
Cytokine and Chemokine Analyses ............................................................................62 
7.2.10. 
Sarcoidosis Biomarkers ..............................................................................................62 
7.2.11. 
Sample Requirements .................................................................................................62 
7.2.12. 
Pregnancy Testing ......................................................................................................63 
7.3. 
Adverse and Serious Events .......................................................................................64 
7.3.1. 
Adverse Events ...........................................................................................................64 
7.3.2. 
Reporting Serious Adverse Events .............................................................................64 
7.3.3. 
Pregnancy ...................................................................................................................65 
7.4. 
Pharmacokinetic Analysis ..........................................................................................65 
7.5. 
Immunogenicity Assessment ......................................................................................65 


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8. 
SAMPLE SIZE AND DATA ANALYSES ...............................................................66 
8.1. 
Determination of Sample Size ....................................................................................66 
8.2. 
Analysis Populations ..................................................................................................66 
8.2.1. 
Intent-to-treat Population ............................................................................................66 
8.2.2. 
Modified Intent-to-treat Population ............................................................................66 
8.2.3. 
Per-Protocol Population ..............................................................................................66 
8.2.4. 
Safety Population ........................................................................................................66 
8.3. 
General Considerations ...............................................................................................66 
8.4. 
Handling of Missing Data ...........................................................................................66 
8.5. 
Efficacy Analyses .......................................................................................................67 
8.5.1. 
Efficacy Analysis Approaches ....................................................................................67 
8.5.2. 
Adjustment of Multiple Comparisons ........................................................................67 
8.6. 
Safety Analyses ..........................................................................................................67 
8.7. 
Population Pharmacokinetic Analysis ........................................................................68 
8.8. 
Statistical Analysis Plan .............................................................................................68 
8.9. 
Interim Analysis ..........................................................................................................68 
9. 
REFERENCES ...........................................................................................................69 
APPENDIX 1. SCHEDULE OF ASSESSMENTS ....................................................................74 
APPENDIX 2. HEART RHYTHM SOCIETY DIAGNOSTIC CRITERIA BASED ON 
2 DIAGNOSTIC PATHWAYS ..................................................................................79 
APPENDIX 3. ADVERSE EVENT DEFINITIONS AND REPORTING.................................80 
APPENDIX 4. COMPARISON OF SYSTEMIC GLUCOCORTICOID 
PREPARATIONS .......................................................................................................84 
APPENDIX 5. CLINICAL LABORATORY EVALUATIONS ................................................85 
APPENDIX 6. REGULATORY, ETHICAL, AND STUDY OVERSIGHT 
CONSIDERATIONS ..................................................................................................86 
APPENDIX 7. LIVER SAFETY SUGGESTED ACTIONS AND FOLLOW-UP 
ASSESSMENTS .........................................................................................................89 
APPENDIX 8. ORAL CORTICOSTEROID TAPERING PROTOCOL ...................................92 
APPENDIX 9. PATIENT-REPORTED OUTCOMES ASSESSMENTS ..................................93 
King’s Sarcoidosis Questionnaire ..................................................................................................94 
Fatigue Assessment Scale (FAS) ...................................................................................................97 
Subject Global Assessment ............................................................................................................98 


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APPENDIX 10. OTHER REPORTED OUTCOMES ................................................................99 
Modified Glucocorticoid Toxicity Index .......................................................................................99 
APPENDIX 11. DIET PREPARATION RECOMMENDATIONS FOR SUBJECTS 24 
HOURS PRIOR TO PET SCAN ..............................................................................100 
 
 


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LIST OF TABLES 
Table 1. 
Identified and Potential Risks .....................................................................................31 
Table 2. 
Discontinuation Criteria for Subjects with Underlying Bundle Branch Block ..........44 
Table 3. 
Description of Study Treatments ................................................................................47 
Table 4. 
Summary of Standard Echocardiographic Views .......................................................53 
Table 5. 
Additional Imaging Parameters ..................................................................................55 
Table 6. 
Estimated Sample Requirements Per Subject .............................................................63 
 
LIST OF FIGURES 
Figure 1. 
Study Design ...............................................................................................................35 
Figure 2. 
Suggested Liver Injury Stopping Criteria ...................................................................44 
 
 
 


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PROTOCOL SYNOPSIS 
Title of Study 
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study with 
an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy 
of Namilumab in Subjects with Active Cardiac Sarcoidosis 
Indication 
Treatment of cardiac sarcoidosis (CS) 
Study Centers 
Approximately 20 sites within the US 
Study Objective(s) 
Primary Objectives: 
The primary objective of this study is: 
• To determine the safety and tolerability of namilumab in subjects 
with CS based on treatment-emergent adverse events (TEAEs), 
serious adverse events (SAEs), and discontinuations. 
Secondary Objectives: 
The secondary objectives of this study include the following: 
• To evaluate other measures of safety and tolerability of namilumab; 
• To evaluate the efficacy of namilumab on cardiac inflammation 
determined by [18-F] fluorodeoxyglucose (FDG) positron emission 
tomography (PET)/computed tomography (CT) (FDG-PET/CT); 
• To assess the effect of namilumab on cardiac arrhythmia burden; 
• To assess the effect of namilumab on cardiac function; 
• To assess the effect of namilumab on cumulative oral corticosteroid 
(OCS) use and OCS toxicity; 
• To assess the effect of namilumab on use of rescue therapy; 
• To assess the effect of namilumab on patient-reported outcomes 
(PROs): 
o King’s Sarcoidosis Questionnaire (KSQ); 
o Fatigue Assessment Scale (FAS); 
o Subject Global Assessment (SGA). 
• 
To assess the population pharmacokinetics (PPK) and 
exposure-response (E-R) relationships for efficacy and safety of 
namilumab. 
Study Rationale 
Sarcoidosis is a multi-organ autoimmune 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. Patients with CS have 
non-necrotizing granulomas affecting the heart and represent 5% of the 
total sarcoidosis population (approximately 10,000 people in the US). 


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Granulocyte-macrophage colony-stimulating factor (GM-CSF), a 
pro-inflammatory 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 
monocytes/macrophages into tissue, and supporting the crosstalk 
between CD4+ T cells and myeloid cells. Successful late-phase clinical 
trials in rheumatoid arthritis, giant cell arteritis, and severe coronavirus 
disease 2019 (COVID-19) have solidified the pathogenic role of 
GM-CSF in aberrant immune responses. Human tissue and mouse 
model studies over the past 3 decades have implicated GM-CSF in the 
formation of normal granulomas and sarcoid granulomas. GM-CSF 
neutralization with namilumab has the potential to improve outcomes in 
CS by downregulating the granulomatous response that drives the 
disease. 
Study Population 
This study will include adult subjects with active CS. 
Number of 
Planned Subjects 
Approximately 30 total subjects are planned for this study in 2 cohorts; 
Cohort A will enroll 20 subjects; Cohort B will enroll 10 subjects. 
Study Design 
Cohort A will be 34-weeks duration, and will be double-blinded, 
randomized, and placebo-controlled. Twenty subjects will be enrolled; 
10 subjects per arm will receive either namilumab or placebo. All 
subjects will also be treated with prednisone 25-60 mg/day, or 
equivalent, in addition to other immunosuppressive therapy (IST) they 
may already be receiving. The Investigator will determine the starting 
dose of OCS. Subjects will be treated with prednisone at a dose ranging 
between 25-60 mg/day, or equivalent. Subjects should begin OCS 
treatment any time after the completion of the screening PET scan 
through completion of the Baseline Visit. Note the timing requirement 
for the OCS and PET scan pertains to the intended study dose of OCS 
(25-60 mg/day of prednisone or equivalent) and not to any pre-existing 
treatment of ≤10 mg/day of prednisone or equivalent. Subjects must 
agree to taper OCS over 22 weeks after randomization.  
Cohort B is 34 weeks in duration, open-label, and with a single arm. 
Ten subjects will be enrolled. Eligible subjects for Cohort B are those 
who otherwise qualify for Cohort A but prefer not to receive high-dose 
OCS, or, in the opinion of the Investigator, are not suitable candidates 
to take prednisone 25-60 mg/day. The reason for not providing 
high-dose OCS should be documented in the subject’s chart and source 
records. Subjects will receive open-label namilumab in addition to their 
background therapy without change to any ongoing OCS dose 
(≤10 mg/day of prednisone or equivalent) or IST medication(s) and 
dose(s). 


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Study Treatments 
Cohort A: 
• 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 30. 
• Treatment Arm 2: Placebo administered to match namilumab 
dosing. 
Subjects randomized to Treatment Arm 1 or 2 will also be treated with 
prednisone 25-60 mg/day, or equivalent, in addition to any other 
background IST they are already receiving.  
Cohort B: 
• Namilumab administered SC: 150 mg on Day 1, Day 15 (Week 2), 
and then Q4W thereafter through Week 30. 
Subjects enrolled in Cohort B must continue their background therapy 
without change to any ongoing OCS dose (≤10 mg/day of prednisone 
or equivalent) or ISTs. 
Treatment and 
Study Duration 
Participation will be approximately 44 weeks (308 days) as follows: 
• Up to 6-week (42 days) Screening Period; 
• 34-week (238 days) Treatment Period (with steroid tapering during 
the first 22 weeks for subjects participating in Cohort A); 
• Follow-up phone call approximately 4 weeks (28 days) after the 
End-of-Treatment (EOT) Visit (approximately 8 weeks [56 days] 
after the last dose of study drug at Week 30). 
Study Endpoint(s) 
Primary Endpoints: 
The primary endpoint of this study includes the following: 
• Incidence and severity of TEAEs, SAEs, and adverse events (AEs) 
leading to discontinuation.  
Secondary Endpoints: 
• Other safety endpoints including: 
o 
Incidence and magnitude of treatment-emergent laboratory 
abnormalities; 
o 
Change from baseline in vital signs; 
o 
Change from baseline in electrocardiogram (ECG) 
parameters. 


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• Mean change from baseline in PET maximum standardized update 
value (SUVmax), SUVmean, and total glycosylation;  
• Cumulative arrhythmia burden and hospitalization for cardiac 
events; 
• Mean change from baseline in left ventricular ejection fraction 
(LVEF) and global longitudinal strain (GLS) on transthoracic 
echocardiogram (TTE); 
• Cumulative oral steroid use, modified glucocorticoid toxicity index 
(mGTI), and mean change from Baseline in glycosylated 
hemoglobin (HbA1C); 
• Proportion of subjects requiring rescue therapy (either cohort) and 
proportion of subjects successfully achieving steroid taper without 
requiring rescue therapy (Cohort A); 
• Mean change from baseline in KSQ (General and sub-domains), 
Fatigue Assessment Scale (FAS), and Subject Global Assessment 
(SGA); 
• Assessments of PPK and E-R relationships for safety and efficacy if 
data permit.  
Note: For endpoints defined as mean change from baseline, the primary 
assessment will be at Week 34. 
Inclusion Criteria 
An individual will be eligible for participation in this study only if 
all the following inclusion criteria are met: 
1. Male or female age ≥18 years. 
2. Able and willing to provide written informed consent, which 
includes compliance with study requirements and restrictions 
listed in the consent form. 
3. History of documented sarcoidosis (must include histological 
confirmation, from any organ, in the subject’s medical history 
or records). 
4. Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria 
(modified). 
5. PET SUVmax ≥3 at Screening and scan consistent with active 
CS on central over-read. 
6. If receiving OCS, dose must have been ≤10 mg of prednisone or 
equivalent, and dose must have been stable for at least 4 weeks 
prior to completion of the screening PET scan.  
7. For subjects in Cohort A: subjects must agree to be treated with 
high-dose OCS and agree to taper their OCS at the time of 
randomization. 
8. If receiving methotrexate and/or other IST, dose must have been 
stable for ≥3 months prior to completion of the screening PET 
scan.  


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9. Female subjects must agree to use an approved highly effective 
birth control (BC) method (<1% failure rate per year) for at 
least 28 days prior to randomization, throughout the study, and 
for at least 8 weeks (56 days) post last dose of study drug, 
unless documented to have a reproductive status of 
nonchildbearing potential or is postmenopausal: 
• Non-childbearing potential defined as pre-menopausal 
female with medical history of bilateral tubal ligation, 
bilateral oophorectomy (removal of the ovaries), bilateral 
salpingectomy, bilateral tubal ligation, bilateral 
hysteroscopic sterilization, or total hysterectomy at least 
3 months prior to Screening. 
• Postmenopausal defined as 12 months of spontaneous 
amenorrhea; otherwise, a follicle-stimulating hormone 
(FSH) confirmation will be required. For females with 
questionable menopausal history (e.g., irregular menstrual 
periods and age >40 years), a documented serum FSH level 
must be ≥30 mIU/mL. 
• Woman of childbearing potential (WCBP) who is already 
using an established method of highly effective 
contraception or agrees to use one of the allowed BC 
methods, for at least 28 days prior to randomization, 
throughout the study, and for 8 weeks (56 days) following 
the last dose of study drug. 
10. Male subjects must agree to, and attest that, female partners of 
childbearing potential are using one of the allowed highly 
effective methods of contraception as described above for at 
least 28 days prior to randomization/enrollment, throughout the 
study, and for 8 weeks (56 days) 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 
1. Hospitalized for any respiratory or cardiac illness ≤30 days 
prior to Screening. 
2. Known pulmonary hypertension requiring therapy. 
3. Systemic (oral or parenteral) antibiotic or pulse OCS treatment 
for any indication within 42 days prior to randomization. 
4. Autoimmune disease other than sarcoidosis likely to require 
treatment during the subject’s participation in this study. 
5. Symptoms and/or signs of extracardiac sarcoidosis that are 
likely to warrant treatment in addition to that required for the 
subject’s cardiac disease. 
6. Estimated glomerular filtration rate (eGFR) 
≤30 mL/min/1.73 m2 (Modification of Diet in Renal Disease 


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[MDRD] equation) or requiring renal replacement therapy. 
7. Alanine aminotransferase (ALT), aspartate aminotransferase 
(AST), or alkaline phosphatase (ALP) >2 × upper limit of 
normal (ULN). 
8. Platelet count <100,000 per mm3. 
9. Hemoglobin ≤9.5 g/dL. 
10. Absolute neutrophil count <1,000 per mm3. 
11. Serum albumin-corrected calcium >3.5 mmol/L (14 mg/dL). 
12. Positive anti-GM-CSF autoantibody, or history of pulmonary 
alveolar proteinosis (PAP). 
13. Use of any biologic immunomodulator (approved or 
investigational) within the 6 months prior to Screening. 
Allergens for hypersensitivity desensitization or vaccines are 
not excluded per this criterion. Treatment with immunoglobulin 
within 6 months prior to Screening. Treatment with any 
investigational immunomodulator (e.g., Neuropilin 2 [NRP2] 
modulator) within 6 months prior to Screening. 
14. Treatment with any Janus kinase (JAK) inhibitor within 
3 months prior to Screening. 
15. Participation in another interventional clinical trial within 
6 months prior to Screening and throughout the duration of 
participation in this study. 
16. History of left ventricular ejection fraction (LVEF) ≤30% or 
NYHA class III or IV heart failure. 
17. 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. 
18. Systolic blood pressure (SBP) <90 or >180 mm Hg; Diastolic 
blood pressure (DBP) <60 or >110 mm Hg at Screening. 
19. Has documented laboratory-confirmed severe acute respiratory 
syndrome coronavirus-2 (SARS-CoV-2) infection as 
determined by polymerase chain reaction (PCR) or other 
approved clinical testing ≤3 months prior to randomization. 
20. Administration of any fully live virus or bacterial vaccinations 
within 3 months prior to 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. 
21. History of mycetoma or fungal respiratory infection. 
22. History of or planned solid organ or hematopoietic cell 
transplantation. 


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23. A diagnosis of, or presentation consistent with, Lofgren’s 
syndrome. 
24. Significant ischemic heart disease, including myocardial 
infarction within 6 months, unstable angina, or percutaneous 
transluminal coronary angioplasty (PTCA)/stent within 1 month 
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. 
25. Significant valvular heart disease known or anticipated to 
require surgical repair or replacement during the subjects’ 
participation in this study. 
26. Subject is indicated for a permanent implantable cardioverter 
defibrillator (ICD) or permanent pacemaker (per Investigator’s 
opinion) but not yet implanted for any reason, or not planned to 
be implanted, at least 1 week before initiating treatment with 
study drug. Subjects with temporary pacing devices or external 
defibrillator devices are excluded under this criterion even if 
planned for conversion to a permanent device if that cannot 
occur at least 1 week prior to treatment with study drug. 
27. Known or suspected active and untreated/inadequately treated 
tuberculosis (TB), human immunodeficiency virus (HIV), 
hepatitis B or C infection. Subjects with latent TB may be 
enrolled if anti-TB therapy is commenced prior to 
randomization. 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. 
28. Female subjects who are pregnant or breastfeeding or intend to 
be, during the study. 
29. Prior history of any malignancy (not including fully resected 
squamous 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. 
30. History of severe allergic or anaphylactic reactions to 
therapeutic proteins or known sensitivity to namilumab or to its 
inactive components. 
31. History of alcohol or drug abuse, in the Investigator’s opinion, 
unless in full remission for greater than 12 months prior to 
Screening. 
32. Abnormal chest radiograph findings that are inconsistent with a 
diagnosis of sarcoidosis, or are inconsistent with the subjects 
past medical history, and that warrant further evaluation in the 
opinion of the Investigator. 
33. Any other acute or chronic medical condition that, in the 
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associated with study participation or investigational product 
administration, or may interfere with the interpretation of study 
results, and would make the participant inappropriate for entry 
into this study. 
Database Lock 
A final database lock will be performed after last subject’s last visit, 
and final data will be provided for all analyses. 
Statistical Analyses Determination of Sample Size 
The sample size for this study is not based on formal statistical 
calculations of study power. The planned sample size is considered 
sufficient to meet the primary objective. 
Populations for Analysis 
• The Intent-to-Treat (ITT) Population will include all 
randomized/enrolled subjects. 
• The modified Intent-to-Treat (mITT) Population will include all 
randomized/enrolled subjects who receive any amount of study 
drug and have at least one assessment at baseline or post-baseline 
for efficacy endpoints defined as changes from baseline. The mITT 
will be analyzed according to the treatment assigned. All efficacy 
endpoint analyses will be performed using the mITT Population. 
• The Per-Protocol (PP) Population will include all subjects in the 
ITT Population who have no major protocol violations. The 
PP Population will be used for sensitivity analyses of the efficacy 
measurements. 
• The Safety Population (SP) will include all randomized/enrolled 
subjects who receive any amount of study drug. The SP will be 
analyzed according to the treatment received. The SP will be used 
for safety analyses. 
Statistical Analyses in General 
All statistical analyses will be conducted using SAS, Version 9.3 or 
later. 
All the continuous variables, including the changes from baseline, will 
be summarized by the treatment with the means, standard deviation 
(SD), medians, and the ranges. All the categorical variables will be 
summarized by the treatment with numbers and percentages of the 
subjects.  
The Data Monitoring Committee (DMC) will be responsible for closely 
reviewing the unblinded safety data and for providing their 
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Efficacy Analysis 
Efficacy analysis will be provided separately for subjects in Cohort A 
and Cohort B. 
No hypothesis testing is planned for efficacy endpoints analyses. For 
continuous efficacy endpoints, summary statistics such as means, 
medians, and SDs will be provided by treatment groups. Model-based 
LS means and confidence intervals (CIs) for within treatment estimates 
and between treatment differences (Cohort A) will also be provided.  
Categorical efficacy endpoints will be summarized by treatment with 
counts and percentages of the subjects. CIs for within treatment 
estimate and between treatment differences (Cohort A) will also be 
provided. 
Time to event endpoints will be summarized using the Kaplan-Meier 
method. 
Adjustment of Multiple Comparisons 
No hypothesis testing is planned. 
Interim Analysis 
No formal interim analysis is planned. 
Safety Analyses 
Safety analysis will be provided separately for subjects in Cohort A and 
Cohort B, as well as pooled across the 2 cohorts. 
Safety will be assessed based on the SP for AEs, ECGs, PEs, vital 
signs, and clinical laboratory tests. Full details will be described in the 
Statistical Analysis Plan (SAP).  
Population Pharmacokinetic and Biomarker Analyses 
The PPK and E-R analyses will be performed based on modeling 
analysis plan (MAP) and reported separately from the final clinical 
study report. The MAP will be submitted to the Food and Drug 
Administration (FDA) prior to unblinding subject data for analysis. 
Statistical Analysis Plan (SAP) 
A detailed SAP will be signed and submitted to the FDA prior to 
database lock. 
Current Version 
and Effective Date 
Version 2.0 (Amendment 1): 14-April-2022 
Previous 
Version(s) and 
Effective Date(s) 
Original Protocol Version 1.0: 08-Dec-2021 


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Study Director 
 
Telephone: 
 
Email: 
 
 
PPD
PPD
PPD


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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 
AST 
aspartate aminotransferase 
BC 
birth control 
BP 
blood pressure 
BUN 
blood urea nitrogen 
CABG 
coronary artery bypass graft 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
COVID-19 
coronavirus disease 2019 
CRA 
clinical research associate 
CRO 
contract research organization 
CRP 
C-reactive protein 
CS 
cardiac sarcoidosis 
CT 
computed tomography 
DAS 
Disease Activity Score 
DBP 
diastolic blood pressure 
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 
EOS 
End-of-Study 
EOT 
End-of-Treatment 
E-R 
exposure-response 


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ESR 
erythrocyte sedimentation rate 
ET 
Early Termination 
FAS 
Fatigue Assessment Scale 
FDA 
Food and Drug Administration 
FDG 
fluorodeoxyglucose 
FIH 
first-in-human 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
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 
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 
ICD 
implantable cardioverter defibrillator 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
ICSRs 
Individual Case Safety Reports 
Ig 
immunoglobulin 
IgG1κ 
immunoglobulin G1 kappa 
IGRA 
interferon gamma release assay 
IL 
interleukin 
IMP 
investigational medicinal product 
INR 
international normalized ratio 


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IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IST(s) 
immunosuppressive therapy(ies) 
ITT 
Intent-to-Treat 
IV 
intravenous 
JAK 
Janus kinase 
KSQ 
King’s Sarcoidosis Questionnaire 
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 
MGC(s) 
multinucleated giant cell(s) 
mGTI 
modified glucocorticoid toxicity index 
mITT 
modified Intent-to-Treat 
mRNA 
messenger ribonucleic acid 
NT-proBNP 
N-terminal (NT)-pro hormone brain natriuretic peptide 
NYHA 
New York Heart Association 
OCS 
oral corticosteroid(s) 
OLE 
open-label extension 
PAP 
pulmonary alveolar proteinosis 
PE 
physical examination 
PET 
positron emission tomography 
PK 
Pharmacokinetic(s) 
PP 
Per-Protocol 
PPK 
population pharmacokinetics 
PRO(s) 
patient-reported outcome(s) 
PTCA 
percutaneous transluminal coronary angioplasty 
PV 
pharmacovigilance 
Q4W 
every 4 weeks 


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QTcF 
Fridericia corrected QT interval 
RA 
rheumatoid arthritis 
RBC(s) 
red blood cell(s) 
RT-PCR 
real time-polymerase chain reaction 
SAA 
serum amyloid A 
SAE(s) 
serious adverse event(s) 
SAP 
statistical analysis plan 
SC 
subcutaneous(ly) 
SD 
standard deviation 
SGA 
Subject Global Assessment 
SOA 
Schedule of Assessments 
SOC 
system organ class 
SP 
Safety Population 
SP-D 
serum surfactant protein D 
TARC 
thymus and activation-regulated chemokine 
TB 
tuberculosis 
TC 
total cholesterol 
TEAE(s) 
treatment-emergent adverse event(s) 
TG(s) 
triglyceride(s) 
TNF 
tumor necrosis factor 
TTCW 
time-to-clinical worsening 
TTE 
transthoracic echocardiography 
ULN 
upper limit of normal 
VEGF 
vascular endothelial growth factor 
WBC(s) 
white blood cell(s)  
WCBP 
woman of childbearing potential 
 
 
 


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1. 
INTRODUCTION 
Namilumab (KIN-1902, IZN-101, MT203, or AMG203) is a human immunoglobulin G1kappa 
(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 a multitude of inflammatory and autoimmune human diseases. 
Sarcoidosis is highly heterogeneous condition, with effects ranging from chest radiograph 
abnormalities during routine screening of asymptomatic subjects to severe chronic disease with 
pulmonary fibrosis. In a large portion of subjects, 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 sarcoidosis, and pulmonary hypertension, which 
occurs in at least 5% of subjects, and is a serious complication. Oral corticosteroids (OCS) are 
the mainstay of therapy, but chronic subjects require long-term dosing, which carries significant 
toxicities (Baughman, 2015; Khan, 2017; 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 -steroid 
sparing immunosuppressive therapies (ISTs). Only about two-thirds of subjects are responsive to 
these therapies, and only 25% of subjects achieve full weaning off OCS (Crommelin, 2016; 
Beegle, 2013). For subjects who are unresponsive or intolerant to DMARDs, third-line therapy 
consists of anti-tumor necrosis factor (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 use 
to treat sarcoidosis and some subjects 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 safety and preliminary evidence of efficacy of 
namilumab in subjects who have active cardiac sarcoidosis (CS). If successful, the results will 
inform the design of a further clinical trials and registration of namilumab as the first novel 
therapy for sarcoidosis in decades and the first biologic option for this disease. 
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. Normal granulomas contain central necrosis and form in 
response to foreign pathogens that cannot be eliminated. In contrast, sarcoid granulomas do not 
contain necrosis, and the cause of their formation is unknown. 


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The clinical course of sarcoidosis is highly heterogeneous, ranging from chest radiograph 
abnormalities discovered during routine screening of asymptomatic individuals to severe disease 
in patients with pulmonary fibrosis. Approximately 200,000 individuals are affected with 
sarcoidosis in the US (Baughman, 2016). About 25% to 33% of these patients have persistent 
granulomas and develop a chronic progressive disease that significantly impacts 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 immunosuppressive 
steroid-sparing agents, only 25% of patients achieve full weaning off OCS. Both OCS and ISTs 
often 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. 
Patients with CS have non-necrotizing granulomas affecting the heart and represent 5% of the 
total sarcoidosis population (approximately 10,000 people in the US). The clinical manifestations 
include conduction abnormalities, arrhythmias (ventricular tachycardia/ventricular fibrillation), 
congestive heart failure, and sudden death (Hulten, 2016). Sarcoid granulomas may involve any 
part of the heart, although the left ventricle is the most commonly affected chamber. Prognosis of 
CS is related to extent and site(s) of involvement. Most deaths are due to arrhythmia or 
conduction defects; progressive heart failure due to massive granulomatous infiltration of the 
myocardium accounts for at least 25% of deaths (Lynch, 2014).  
In addition to immunosuppressive and steroid-sparing therapies, patients with CS are treated 
with guideline-directed medical therapies for electrophysiological and heart failure 
manifestations (Gilotra, 2020). Data on immunosuppressive management is largely extrapolated 
from non-CS literature and from limited retrospective cohorts of CS patients and the role of these 
agents needs to be further defined in efforts to decrease the morbidity associated with 
corticosteroids. (Gilotra, 2020). Many CS patients are already being treated for arrythmia with a 
pacemaker or implantable cardioverter defibrillator (ICD). 
Treatment with an anti-GM-CSF agent to impact the development of CS granulomas would aim 
to suppress inflammation, minimize recurrences, and decrease incidence of arrhythmias and the 
need for pacemakers. All second- and third-line therapies are not FDA approved for use in 
sarcoidosis, supporting the need for new therapies for use in this condition. 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 


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(Hamilton, 2020), giant cell arteritis (Cid, 2020), and severe coronavirus disease 2019 
(COVID-19) (Temesgen, 2021; 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, a multitude of human tissue and mouse model studies 
have shown that GM-CSF plays a key role in the formation of granulomas, including sarcoid 
granulomas. 
GM-CSF is an important cytokine during multiple parts of the granulomatous response, 
including the fusion of macrophages into MGCs (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 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-Juarrero, 2005). Specific GM-CSF expression in 
either lung epithelial cells or T cells alone partially restored control of Mycobacterium 
tuberculosis infection in GM-CSF-/- mice (Gonzalez-Juarrero, 2005; Rothchild, 2017). 
Administration of anti-GM-CSF neutralizing antibody 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., 2019, 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).  
 
Tchernev, 2006  


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Multiple different 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 vs 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 upregulated 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). 
Taken together, GM-CSF is a key regulator of granulomatous responses, and significant 
evidence suggests that GM-CSF may drive sarcoid granuloma formation. Namilumab, an mAb 
that neutralizes GM-CSF, has the potential to improve organ function in CS 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 CS 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. To date, no 
patient 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., 2015, 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., 2016, 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. Indeed, high titers 
of autoantibodies against GM-CSF have been associated with infection (Rosen, 2013). 
Nevertheless, no anti-GM-CSF or anti-GM-CSFR trials have reported an increased infection risk 


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(Hamilton, 2020). Unlike trials of TNF-targeting agents, no increase in TB has been observed, 
despite GM-CSF’s role in granuloma formation and TB protection in mice (Bryson, 2019; 
Hamilton, 2020). This benign safety profile has been corroborated in recently reported (not yet 
peer reviewed) trials of anti-GM-CSF mAbs for severe hospitalized COVID-19 subjects who 
were expected to be particularly susceptible to opportunistic infection (Patel, 2021; 
Temesgen, 2020). One suspected unexpected serious adverse reaction of bacterial pneumonia 
was reported in the COVID-19 Investigator-initiated study (CATALYST). 
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 
subjects (0.2 mg/kg to 8 mg/kg IV), a spontaneously reversible trend in decreased white blood 
cell (WBC) and absolute neutrophil count was observed in some subjects dosed with namilumab. 
The decrease in WBC was not clinically significant, and there was no dose-dependent pattern. 
Two subjects had clinically significant low neutrophil values during the trial: 1 subject on 
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 on 3 mg/kg namilumab had a neutrophil count of 
1.1×109/L on Day 29 and recovered spontaneously 4 days later. Both subjects recovered 
spontaneously without medical intervention. In the NEXUS study, neutrophil count, and WBC 
count decrease were recorded as drug related for 1 subject in the namilumab 80 mg treatment 
group and 1 subject in the namilumab 150 mg treatment group. 
Neutralization of GM-CSF potentially may 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 and neutropenia have 
been reported with namilumab. 
In the FIH 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 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 
adverse event (AE). In a Phase 2 study in RA (NEXUS), ALT and AST increases were 
considered drug-related in 1 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 NAMASTE study, 3 non-serious reports 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.  
In the FIH study, 1 subject experienced a wide-complex tachycardia with a frequency of 
approximately 168 beats-per-minute on 3 occasions, each lasting for approximately 6 seconds, 
occurring 2 hours and 14 minutes after the end of the 1-hour IV infusion of 3 mg/kg namilumab. 
The subject only sensed a fast heartbeat when he was sitting up from a supine position. There 


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was no faintness or dizziness or any other AE during the event or at any later time. 12-lead 
electrocardiogram (ECG) showed no clinically significant abnormalities and no repeat of 
arrhythmia. The QT interval and the corrected QT interval according to Bazett’s formula values 
were normal. This event was recorded and reported as a wide-complex tachycardia SAE of mild 
intensity, likely related to infusion of investigational medicinal product (IMP). The arrhythmia 
was evaluated by 2 independent cardiologists; both judged the event as tachycardia 
supraventricular with aberrant conduction but not as a life-threatening or medically serious 
event. One cardiologist suggested that the arrhythmia could indicate a vagal response, possibly 
due to a change in body position. However, a relation with the infusion of namilumab could not 
be excluded. The subject recovered fully and immediately with no sequelae. Subsequent 
cardiology follow-up examinations did not reveal any particular finding; no therapeutic actions 
were needed. In further clinical development, no further events of cardiac arrhythmia have been 
reported. Currently, the 1 reported event is not considered evidence of increased arrhythmia risk 
with namilumab; however, subjects with active CS may be at increased risk of arrhythmia and 
hence all subjects in the clinical trial will be carefully monitored for such events. 
As with any biologic therapy, hypersensitivity reactions are considered a potential risk. Infusion 
reactions may be either type I hypersensitivity reactions (i.e., 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. 
The subcutaneous (SC) injection may cause administration site pain or inflammation; however, 
no such reactions have been recorded to date. 
Namilumab has been studied in humans in doses ranging from 0.2 mg/kg to 8 mg/kg in 
Study M1 1188 001 EM; 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, 50 mg, 80 mg, 150 mg, 
and 300 mg in Study M1 1188 203 (NEPTUNE); at 150 mg in Study IZN 101 (NAMASTE); and 
at 150 mg in an Investigator-initiated trial (CATALYST). To date, 403 subjects or healthy 
volunteers have been enrolled into the clinical development program for namilumab, with 
332 subjects estimated to have received namilumab. In addition, 57 subjects with COVID-19 
were treated with a single dose of 150 mg namilumab in an Investigator-initiated trial in the UK 
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 
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 et al, 2018). 
Given that no new therapy has been approved for sarcoidosis in decades, namilumab may prove 
to be a useful treatment for these patients with limited options. 


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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 important identified risks: 
• AST and/or ALT elevation. 
The following have been delineated as important potential risks: 
• Decreased neutrophil count/mild neutropenia; 
• PAP; 
• Hypersensitivity/allergic reactions (IgE-mediated; non-IgE-mediated); 
• Infection. 
Based on nonclinical studies and the available data from 8 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 CS. 
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. 
Table 1. 
Identified and Potential Risks 
Risk 
Source 
Key Details 
Actions 
AST/ALT elevation 
Nonclinical studies 
(single-dose and repeat-dose 
toxicity studies); clinical 
studies (FIH, PRIORA, 
NEXUS, NEPTUNE, and 
NAMASTE studies) 
Important identified risk 
Exclusion criteria; 
routine 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 and 
management 


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Table 1. 
Identified and Potential Risks 
Risk 
Source 
Key Details 
Actions 
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 


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2. 
OBJECTIVES AND ENDPOINTS 
2.1. 
Objectives 
The primary objective of this study is: 
• To determine the safety and tolerability of namilumab in subjects with CS based on 
treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and 
discontinuations. 
Secondary Objectives: 
The secondary objectives of this study include the following: 
• To evaluate other measures of safety and tolerability of namilumab; 
• To evaluate the efficacy of namilumab on cardiac inflammation determined by [18-F] 
fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography 
(CT) (FDG-PET/CT); 
• To assess the effect of namilumab on cardiac arrhythmia burden; 
• To assess the effect of namilumab on cardiac function; 
• To assess the effect of namilumab on cumulative oral corticosteroid (OCS) use and OCS 
toxicity; 
• To assess the effect of namilumab on use of rescue therapy; 
• To assess the effect of namilumab on patient-reported outcomes (PROs): 
o King’s Sarcoidosis Questionnaire (KSQ); 
o Fatigue Assessment Scale (FAS); 
o Subject Global Assessment (SGA); 
• To assess the population pharmacokinetics (PPK) and exposure-response (E-R) 
relationships for efficacy and safety of namilumab. 
2.2. 
Endpoints 
Primary Endpoints: 
The primary endpoint of this study includes the following: 
• Incidence and severity of TEAEs, SAEs, and adverse events (AEs) leading to 
discontinuation. 
Secondary Endpoints: 
• Other safety endpoints including: 
o Incidence and magnitude of treatment-emergent laboratory abnormalities; 
o Change from baseline in vital signs; 
o Change from baseline in ECG parameters. 


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• Mean change from baseline in PET maximum standardized update value (SUVmax), 
SUVmean, and total glycosylation;  
• Cumulative arrhythmia burden and hospitalization for cardiac events; 
• Mean change from baseline in left ventricular ejection fraction (LVEF) and global 
longitudinal strain (GLS) on transthoracic echocardiogram (TTE); 
• Cumulative oral steroid use, modified glucocorticoid toxicity index (mGTI), and mean 
change from Baseline in glycosylated hemoglobin (HbA1C); 
• Proportion of subjects requiring rescue therapy (either cohort) and proportion of subjects 
successfully achieving steroid taper without requiring rescue therapy (Cohort A); 
• Mean change from baseline in KSQ (General and sub-domains), Fatigue Assessment 
Scale (FAS), and Subject Global Assessment (SGA); 
• Assessments of PPK and E-R relationships for safety and efficacy if data permit. 
Note: For endpoints defined as mean change from baseline, the primary assessment will be at 
Week 34. 
3. 
INVESTIGATION PLAN 
3.1. 
Overall Study Design and Plan Description 
This is a Phase 2a, 2-cohort study including a randomized, double-blind, placebo-controlled 
cohort (Cohort A), and an open-label cohort (Cohort B) assessing the safety and tolerability of 
namilumab in subjects with active CS. 
Approximately 30 total subjects are planned for this study. Cohort A will include 20 subjects. 
Cohort B is open-label and will include 10 subjects. 
Participation will be approximately 44 weeks (308 days) as follows: 
• Up to 6-week (42 days) Screening Period; 
• 34-week (238 days) Treatment Period (with steroid tapering during the first 22 weeks for 
subjects participating in Cohort A); 
• Follow-up phone call approximately 4 weeks (28 days) after the End-of Treatment (EOT) 
Visit (approximately 8 weeks [56 days] after the last dose of study drug at Week 30). 
The study design is presented in Figure 1. 
 


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Figure 1. 
Study Design 
 
 
 


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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 42 days; however, subjects may be 
randomized/enrolled as soon as they are deemed eligible. 
For Cohort A, all subjects will also be treated with prednisone 25-60 mg/day, or equivalent, in 
addition to any other background IST they are already receiving. The starting dose of OCS will 
be determined by the Investigator. Subjects will be treated with prednisone 25-60 mg/day, or 
equivalent, no sooner than after completion of the Screening PET/CT scan, or by the Baseline 
Visit at the latest. Note the timing requirement for the OCS and PET/CT scan pertains to the 
intended study dose of OCS (25-60 mg/day of prednisone or equivalent) and not to any pre-
existing treatment of ≤10 mg/day of prednisone or equivalent. In addition, subjects must agree to 
taper OCS over 22 weeks after randomization. 
For the purpose of the study, the screening PET/CT scan is considered to be either the scan 
performed after informed consent or a scan performed as part of usual care of the subject 
(e.g. for clinical diagnosis of suspected CS) that meets eligibility criteria as further defined in 
Section 7.1.2.1.  
For Cohort B, subjects who, in the opinion of the Investigator, are not eligible for, or prefer not 
to receive, high dose OCS as required in Cohort A, will be enrolled in this cohort. The reason for 
not providing high dose OCS should be documented in subject’s chart. All subjects will receive 
open-label namilumab in addition to their background therapy without change to their prior OCS 
dose (≤10 mg/day of prednisone or equivalent) or ISTs. 
3.1.2. 
34-week Treatment Period 
All subjects will begin the 34-week Treatment Period after confirmation that all protocol 
eligibility criteria have been met. The Treatment Period includes up to 11 clinic visits and 
16 phone or telemed visits as described in the Schedule of Assessments (SOA; Appendix 1). 
Subjects in Cohort A will begin tapering their OCS at the time of randomization as described in 
Appendix 8. During the steroid taper period, Investigators will contact subjects weekly via phone 
or telemed visits as outlined in Appendix 1. 
If a subject needs to discontinue study drug (temporarily or permanently) or terminate study 
participation before completion of the Treatment Period, please refer to Section 4.4.2 for detailed 
instructions regarding recommended follow-up. 
3.1.3. 
Follow-up Period 
All subjects will have a contact (telephone call) approximately 8 weeks (56 days) after the last 
dose of study drug to obtain information on concomitant medication use and SAEs or any AEs 
that were ongoing at the time of the EOT/Early Termination (ET) Visit. See the SOA 
(Appendix 1) for details on what assessments are required. 


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3.1.4. 
Unscheduled Visits 
During the course of the study, additional contact by telephone 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 telephone 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 telephone contact or site visit. If an unscheduled visit 
occurs due to the need for rescue therapy the Investigator should follow the instructions in 
Section 3.1.4.1 prior to commencing rescue. 
3.1.4.1. 
Rescue Visit 
During the study, if a subject requires rescue therapy outside of a required study visit, the 
Investigator should schedule a Rescue Visit to confirm the need for rescue therapy. Prior to 
providing rescue therapy, and dependent on the subject’s clinical condition, the Investigator 
should attempt to complete all efficacy assessments that would be required during a Week 10 
(Cohort B), or Week 22 (Cohort A) in-clinic visit as outlined in Appendix 1. The Rescue Visit 
should be documented on the appropriate eCRF page. 
3.2. 
Discussion of Study Design, Including the Choice of Control Group 
This study is an exploratory trial evaluating safety and tolerability of namilumab compared to 
placebo and in an open-label cohort in subjects with active CS. A robust, double-blind, 
randomized, placebo-controlled design has been selected for Cohort A. Such a design will 
provide strong evidence concerning the use of GM-CSF inhibition for the treatment of CS in 
addition to standard of care high dose OCS. It has been designed to closely match the standard of 
care for many CS subjects who would be typically treated with high dose OCS, then followed 
using [18-F] FDG-PET/CT scanning for response. Cohort B is designed to assess subjects who 
only receive open label namilumab in addition to their background OCS and/or IST. It has been 
designed to closely match the standard of care for those who are ineligible for, or who prefer not 
to receive high dose OCS. Although not placebo controlled, this cohort will provide evidence of 
the activity of namilumab in CS when used alone in addition to stable background therapy.  
The trial is designed overall to provide strong evidence of safety and tolerability and preliminary 
evidence of the efficacy of namilumab in CS subjects and provide the evidence to support the 
further development of namilumab in this disease. 
3.3. 
End of Study Definition 
Study completion for each subject is defined as having completed the End-of-Study (EOS) 
Follow-up Phone 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 
Namilumab 150 mg SC on Days 1 and 15 followed by every 4 weeks (Q4W) through Week 30 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 


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in the Disease Activity Score (DAS) 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. Thirty weeks of 
treatment is considered the minimum duration to fully understand the kinetics of the efficacy 
response to namilumab in the CS population. There are currently no known biomarkers for 
sarcoidosis and a lower dose may be sub-optimal for efficacy. 
4. 
SELECTION OF STUDY 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 the following 
inclusion criteria are met: 
1. Male or female age ≥18 years. 
2. Able and willing to provide written informed consent, which includes compliance with 
study requirements and restrictions listed in the consent form. 
3. History of documented sarcoidosis (must include histological confirmation, from any 
organ, in the subject's medical history or records). 
4. Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria (modified). 
5. PET SUVmax ≥3 at Screening and scan consistent with active CS on central over-read. 
6. If receiving OCS, dose must have been ≤10 mg of prednisone or equivalent, and dose 
must have been stable for at least 4 weeks prior to completion of the screening PET scan. 
7. For subjects in Cohort A: subjects must agree to be treated with high-dose OCS and agree 
to taper their OCS over 22 weeks starting after the time of randomization. 
8. If receiving methotrexate and/or other IST, dose must have been stable for ≥3 months 
prior to completion of the screening PET scan. 
9. Female subjects must agree to use an approved highly effective birth control (BC) 
method (<1% failure rate per year) for at least 28 days prior to randomization, throughout 
enrollment, and for at least 8 weeks (56 days) post last dose of study drug, unless 
documented to have a reproductive status of nonchildbearing potential or is 
postmenopausal: 
• Non-childbearing potential defined as pre-menopausal female with medical history of 
bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), bilateral 
salpingectomy, bilateral tubal ligation, bilateral hysteroscopic sterilization, or total 
hysterectomy at least 3 months prior to Screening. 
• Postmenopausal defined as 12 months of spontaneous amenorrhea; otherwise, a 
follicle-stimulating hormone (FSH) confirmation will be required. For females with 
questionable menopausal history (e.g., irregular menstrual periods and age >40 
years), a documented serum FSH level must be ≥30 mIU/mL. 


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• Woman of childbearing potential (WCBP) who is already using an established 
method of highly effective contraception or agrees to use one of the allowed BC 
methods, for at least 28 days prior to randomization, throughout the study, and for 
8 weeks (56 days) following the last dose of study drug. 
10. Male subjects must agree to, and attest that, female partners of childbearing potential are 
using one of the allowed highly effective methods of contraception as described above 
for at least 28 days prior to randomization/enrollment, throughout the study, and for 8 
weeks (56 days) 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. 
4.2. 
Exclusion Criteria 
An individual will not be eligible for participation in this study if any of the following 
exclusion criteria are met: 
1. Hospitalized for any respiratory or cardiac illness ≤30 days prior to Screening. 
2. Known pulmonary hypertension requiring therapy. 
3. Systemic (oral or parenteral) antibiotic or pulse OCS treatment for any indication within 
42 days prior to randomization. 
4. Autoimmune disease other than sarcoidosis likely to require treatment during the 
subject’s participation in this study. 
5. Symptoms and/or signs of extracardiac sarcoidosis that are likely to warrant treatment in 
addition to that required for the subject’s cardiac disease. 
6. Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 (Modification of Diet in 
Renal Disease [MDRD] equation) or requiring renal replacement therapy. 
7. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline 
phosphatase (ALP) >2 × upper limit of normal (ULN). 
8. Platelet count <100,000 per mm3. 
9. Hemoglobin ≤9.5 g/dL. 
10. Absolute neutrophil count <1,000 per mm3. 
11. Serum albumin-corrected calcium >3.5 mmol/L (14 mg/dL). 
12. Positive anti-GM-CSF autoantibody, or history of pulmonary alveolar proteinosis (PAP). 
13. Use of any biologic immunomodulator (approved or investigational) within the 6 months 
prior to Screening. Allergens for hypersensitivity desensitization or vaccines are not 
excluded per this criterion. Treatment with immunoglobulin within 6 months prior to 
Screening. Treatment with any investigational immunomodulator (e.g., Neuropilin 2 
[NRP2] modulator) within 6 months prior to Screening. 
14. Treatment with any Janus kinase (JAK) inhibitor within 3 months prior to Screening. 
15. Participation in another interventional clinical trial within 6 months prior to Screening 
and throughout the duration of participation in this study. 


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16. History of left ventricular ejection fraction (LVEF) ≤30% or NYHA class III or IV heart 
failure. 
17. 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. 
18. Systolic blood pressure (SBP) <90 or >180 mm Hg; diastolic blood pressure (DBP) <60 
or >110 mm Hg at Screening. 
19. Has documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 
(SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other 
approved clinical testing ≤3 months prior to randomization. 
20. Administration of any fully live virus or bacterial vaccinations within 3 months prior to 
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. 
21. History of mycetoma or fungal respiratory infection. 
22. History of or planned solid organ or hematopoietic cell transplantation. 
23. A diagnosis of, or presentation consistent with, Lofgren’s syndrome. 
24. Significant ischemic heart disease, including myocardial infarction within 6 months, 
unstable angina, or percutaneous transluminal coronary angioplasty (PTCA)/stent within 
1 month 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. 
25. Significant valvular heart disease known or anticipated to require surgical repair or 
replacement during the subjects’ participation in this study. 
26. Subject is indicated for a permanent implantable cardioverter defibrillator (ICD) or 
permanent pacemaker (per Investigator’s opinion) but not yet implanted for any reason, 
or not planned to be implanted, at least 1 week before initiating treatment with study 
drug. Subjects with temporary pacing devices or external defibrillator devices are 
excluded under this criterion even if planned for conversion to a permanent device if that 
cannot occur at least 1 week prior to treatment with study drug. 
27.  Known or suspected active and untreated/inadequately treated tuberculosis (TB), human 
immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with latent TB may 
be enrolled if anti-TB therapy is commenced prior to randomization. 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. 
28. Female subjects who are pregnant or breastfeeding or intend to be, during the study. 
29. Prior history of any malignancy (not including fully resected squamous 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. 
30. History of severe allergic or anaphylactic reactions to therapeutic proteins or known 
sensitivity to namilumab or to its inactive components. 


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31. History of alcohol or drug abuse, in the Investigator’s opinion, unless in full remission for 
greater than 12 months prior to Screening. 
32. Abnormal chest radiographic findings that are inconsistent with a diagnosis of 
sarcoidosis, or are inconsistent with the subjects past medical history, and that warrant 
further evaluation in the opinion of the Investigator. 
33. Any other acute or chronic medical condition 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 participant inappropriate for entry into this study. 
4.3. 
Disease Diagnostic Criteria 
Subjects will require a diagnosis of CS, with histological confirmation of sarcoidosis (any site; 
any organ) in their medical record. A repeat diagnostic workup is not required. Sufficient 
documentation of histology includes a histopathological report in the medical record, or written 
confirmation (letter, email, or fax) from another provider that such a report exists. 
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/enrolled 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 re-consenting. 
No subject may be screened more than twice for inclusion into the trial. 
Note: If the reason for screen failure is related to the central read of [18-F] FDG-PET/CT scans, 
the subject cannot be rescreened. If an eligible [18-F] FDG-PET/CT scan has been completed, 
however, and the subject failed Screening for other reasons and is re-screened successfully, the 
[18-F] FDG-PET/CT scans do not need to be repeated so long as all other inclusion/exclusion 
criteria are satisfied on rescreening and the subject can be randomized/enrolled within 8 weeks of 
the original [18-F] FDG-PET/CT scan. 
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 event; 


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• Noncompliance, including refusal of the drug and/or failure to adhere to the study 
requirements 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; 
• The Sponsor decides to terminate the study. 
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. 
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, not more than one dose may be missed. If more than one dose is missed, the subject 
will be withdrawn from study drug and followed for safety. 
If the Investigator unblinds subject data for safety purposes, study drug will be permanently 
withdrawn. 
4.4.2.3. 
Participant 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 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 and study assessments through the end of the Double-blind 
Treatment Period. 
• 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 the visit schedule. 
• The subject is not willing to be contacted in accordance with the visit schedule but will 
allow the Investigator access to their medical records and EOS contact. 


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• The subject is not willing to allow any direct contact, access to medical records, or 
contact with care provider. In this case, public records may be used to confirm vital status 
at the end of the study. 
For the purpose of this protocol, only subjects who are not willing to allow any direct contact, 
access to medical records, or contact with care provider will be deemed as subjects who have 
withdrawn consent. 
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 above. In accordance with International Conference on 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 as described in the SOA (Appendix 1). 
If the subject or the subject’s representative 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. 
4.4.2.4. 
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. 


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Figure 2. 
Suggested Liver Injury Stopping Criteria 
 
Suggested actions and follow-up assessments can be found in Appendix 7. 
4.4.2.5. 
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. 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 QTcF with Bundle Branch 
Block 
Discontinuation QTcF Threshold with Bundle Branch 
Block 
<450 msec 
>500 msec 
450 to 500 msec 
≥530 msec 


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4.4.2.6. 
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 7.3.3 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 telephone 
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 assessment. 
• 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. 
4.4.4. 
Subject Replacement 
Subjects who are withdrawn from the study may not re-enter the study but may be replaced at the 
Sponsor’s discretion.  
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 Steering Committee, 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 the Steering Committee, Sponsor, and the DMC. Full details on 
the roles of the Steering committee and DMC will be provided in each committee’s respective 
charter. Conditions that may warrant termination of the study include, but are not limited to, the 
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• 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. 
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/GCP guidelines; 
• Inadequate recruitment of participants 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, 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 authorities. 
5. 
STUDY TREATMENTS 
For Cohort A after randomization, subjects will be administered namilumab 150 mg or placebo 
via SC injection on Day 1 (Baseline) and then at Weeks 2, 6, 10, 14, 18, 22, 26, and 30. In 
addition, these subjects will begin tapering their prednisone or equivalent per the guidelines in 
Appendix 8.  


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Subjects in Cohort B will be administered namilumab 150 mg via SC injection on Day 1 
(Baseline) and then at Weeks 2, 6, 10, 14, 18, 22, 26, and 30, in addition to their prior low-dose 
prednisone or equivalent.  
The study drug eCRF will be completed each time study drug is dispensed. 
5.1. 
Treatments Administered 
The identity, potency/strength, and appearance of the study drug 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 in Cohort A.  
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: 
SC injection, which may be 
administered in the thigh, 
abdomen, or upper arm 
SC injection, which may be 
administered in the thigh, 
abdomen, or upper arm 
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. 
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.  
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. 
Namilumab and placebo must be stored at 2°C to 8°C (36°F to 46°F). 
All study drugs 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 
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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 approval 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 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 
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 confirmed as eligible for study participation, the subject will be randomized (if 
in Cohort A) using the Interactive Response Technology (IRT) system. The IRT system will also 
be used for subjects in Cohort B in order to assign the appropriate vial/kit number at each clinic 
visit. Study drug will be dispensed at the study visits summarized in the SOA (Appendix 1). 
Study drug will be administered via SC injection, which may be administered in the thigh, 
abdomen, or upper arm. 
Returned study drug should not be re-dispensed to the subjects. 
5.3.1. 
Dose Modification 
Dose reductions will not be allowed. If a dose reduction is needed, the subject should be 
discontinued from study drug and all EOT assessments completed. See Section 4.4.2.2 for 
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5.4. 
Blinding 
Namilumab 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 in Cohort A will be randomized 1:1 to namilumab or placebo using the IRT. At the time 
of randomization, subjects will be assigned a randomization number by the IRT. Subjects in 
Cohort B will receive unblinded study drug. 
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. 
Treatment compliance will be calculated based on number of used vials returned for each 
subject. 
5.5.2. 
Corticosteroid Use and Taper Compliance 
Corticosteroids (OCS) will be self-administered by the subjects during the study. At each study 
visit, Investigators must review and document a subject’s compliance with OCS use and taper 
during the corticosteroid tapering period and throughout the study until the subject completes 
their EOT/ET Visit. In order to verify corticosteroid dose on a daily basis, subjects will be 
required to complete an eDiary to document their steroid intake. 
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. 


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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 during the study:  
• Recombinant GM-CSF (e.g., sargramostim, molgramostim); 
• Recombinant granulocyte colony-stimulating factor (e.g., filgrastim, lenograstim, 
pegfilgrastim, lipegfilgrastim); 
• 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., anakinra, 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 mAbs against CD20 (e.g., rituximab) and CD3 
(e.g., otelixizumab, teplizumab, visilizumab); 
• Agents targeting the complement pathway (e.g., eculizumab, berinert, cinryze); 
• IV (or SC) Ig; 
• Any other investigational agent not approved by the FDA; 
• Vaccines in general are not permitted with the exception of COVID-19 booster shots and 
routine Flu 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 of a 
subject, the medication will be counted as a rescue medication.  
New use of ISTs, including methotrexate, azathioprine, or mycophenolate mofetil, is subject to 
the rescue requirements discussed in Section 6.4. 
6.3. 
Contraception 
Females of childbearing potential who participate in this study must use highly effective 
contraceptive methods from at least 28 days prior to randomization, throughout the study, and for 
at least 8 weeks (56 days) post last dose of study drug. For this study, females are of childbearing 
potential following menarche and until becoming postmenopausal 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. A high serum FSH level in the postmenopausal range 


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(FSH ≥30 mIU/mL) may be used to confirm a post-menopausal state in women not using 
hormonal contraception or hormonal replacement therapy. 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 considered to be acceptable 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; 
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 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 28 days prior to 
randomization/enrollment, throughout the study and, for 8 weeks (56 days) following the 
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 subject is still practicing 
sexual abstinence and document the discussion in the subject’s source documents. 
Male subjects must agree to, and attest that, female partners of childbearing potential are using 
one of the allowed highly effective methods of contraception as described above for at least 
28 days prior to randomization/enrollment, throughout the study, and for 8 weeks (56 days) 
following the last dose of study drug. 
Urine pregnancy testing for all females of childbearing potential will be performed as specified 
in the SOA (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. 


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6.4. 
Rescue Therapy 
The clinical status of a subject in either Cohort may deteriorate. The Investigator should instruct 
subjects to contact study staff immediately if they feel their symptoms or signs of sarcoidosis, 
particularly of their cardiac disease, are worsening. 
The Investigator may assess that the clinical deterioration is due to progression of CS and may 
wish to provide rescue therapy. In this circumstance, increased OCS dosing at the lowest 
effective increment with the shortest duration is the preferred option so that integrity of the study 
may be preserved. Alternatively, the change in regimen may be increased dosing of a current IST 
or the addition of a new one. 
In this protocol rescue therapy is defined as any of the following: 
• (Cohort A) Failure of the OCS taper, i.e., the subject requires an increase in OCS dose 
during the protocol-specified taper (Appendix 8); 
• (Cohort A) Protocol-specified dose levels cannot be reached by the pre-specified 
timepoints (Appendix 8); 
• (Cohort A) Increase in OCS dose above 10 mg/day prednisone, or equivalent, after the 
taper is complete; 
• (Cohort B) Increase in OCS dose above 10 mg/day prednisone, or equivalent, at any time; 
• (Either Cohort) Start of a new IST or change in dose or frequency of a current IST; 
• (Either Cohort) Use of a prohibited medication to treat sarcoidosis-related signs or 
symptoms. 
The following do not constitute rescue therapy: 
• Use of OCS for up to 14 days or less for treatment of an event not related to sarcoidosis, 
e.g., an acute allergic reaction, acute contact dermatitis; 
• Use of inhaled OCS or bronchodilators, e.g., long-acting beta agonists or long-acting 
muscarinic agonists. 
Prior to initiating rescue therapy in a subject who is not hospitalized, an unscheduled visit should 
be performed; see Sections 3.1.4 and 3.1.4.1 for details. 
If it would not adversely affect a subject’s safety or wellbeing, PET/CT and TTE should be 
performed before initiation of rescue therapy. 
Cohort A subjects should resume the protocol-specified steroid taper (Appendix 8) at the earliest 
opportunity based on the Investigator’s clinical judgement. 
The Medical Monitor must be contacted if rescue therapy is initiated, and the reason(s) should be 
captured in source records and in the CRF. 
7. 
STUDY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarized in the SOA (Appendix 1). As protocol 
waivers or exemptions are not allowed, except for immediate safety concerns, these should be 


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discussed with the Sponsor immediately upon occurrence or awareness to determine if the 
subject should continue or discontinue the study drug. Adherence to the study design 
requirements, including those specified in the SOA, is essential and required for study conduct. 
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 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. 
7.1. 
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, and study drug administration is performed last. 
The study visits should follow the schedule as much as possible and should occur on the same 
day of the week. 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. 
7.1.1. 
Cardiac Testing 
7.1.1.1. 
Transthoracic Echocardiography  
Transthoracic echocardiography (TTE) will be performed at the sites by qualified 
echocardiographic personnel (technicians or physicians) in accordance with standard 
echocardiographic clinical practice and with the Mitchell et al, 2019 Guidelines on TTE in adults 
from the American Society of Echocardiography. The baseline echocardiogram should be 
performed before administration of study medication. The TTE required will be a standard 
echocardiographic examination and will include the majority of standard echocardiographic 
views normally obtained for clinical practice (Table 4). 
Echocardiograms will be recorded to digital media. All digital images should be stored in a 
DICOM format and sent to the core laboratory for analysis. Detailed image acquisition and 
transmission will be provided in Echocardiography Participant Scanning Guide and forwarded to 
all sites. 
All echocardiographic measurements will be made at the core laboratory, with initial evaluation 
performed by experienced ECHO technician, and the overread performed by experienced ECHO 
cardiologist. Detailed echocardiographic parameters, and their definitions will be provided in 
Imaging Review Charter (IRC) and reviewed and approved by the sponsor. 
Table 4. 
Summary of Standard Echocardiographic Views 
Echocardiographic view 
Images 
Parasternal long axis view 
2-D image for septal and posterior wall thickness, volume, and 
ejection fraction measures, LA size/volume 
M-mode images 


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Table 4. 
Summary of Standard Echocardiographic Views 
Echocardiographic view 
Images 
Color flow Doppler 
Parasternal short axis view, 
papillary muscle 
2-D image for septal and posterior wall thickness 
Apical 4-chamber view  
2-D images for volume and ejection fraction measures, LA 
size/volume, and RV function 
Color flow Doppler for assessment of mitral regurgitation 
Global longitudinal strain 
Doppler Tissue Imaging of mitral annular velocities 
Mitral inflow pulsed Doppler 
 
 
 


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Additional images may be acquired if the anatomy is not well visualized on the required views 
(Table 5). 
Table 5. 
Additional Imaging Parameters 
Echo Views 
Parameters 
Parasternal Long Axis View 
● 2D at normal depth 
● Color Doppler of MR and AR 
Parasternal Short Axis View 
● 2D of the LV at Mid-Papillary Muscle level 
Apical 4 Chamber View 
● 2D Standard 4 Chamber view 
● 2D optimize view of the LV 
● 2D with optimize view of the RV, Reduce the depth and focus 
only on the RV 
● Color Doppler of MR 
● Color Doppler of TR 
● CW Doppler of TR jet 
● M-Mode of Tricuspid Annular Motion or TAPSE 
● Tissue Doppler of Tricuspid lateral annulus 
Apical Long Axis View 
● 2D of LA and LV, LVOT 
● Color Doppler for MR 
Apical 2 Chamber View 
● 2D with LV and LA optimized 
● Color Doppler of MR 
7.1.1.2. 
Wearable Device for Arrhythmia Assessment 
An ambulatory ECG monitor (ePatch) will be placed on the subject at each visit (from Screening 
through Week 30). The device is made up of a sensor which is placed in an electrode patch. 
Together, they are placed on the subject. The ePatch will continuously record a 1-channel ECG. 
Subjects will be monitored via ePatch for 10 consecutive days; one patch will be worn for 
5 days, then the patch will be replaced by the subject, and the second patch will be worn for an 
additional 5 days. After 10 days of wearing the device, the Subject should remove it and return it 
to the investigational site at their next clinic visit. The site will upload the data as described in 
the ePatch acquisition guide and give the subject a new device. The initial recording period 
during screening provides an opportunity for the software system that will be used to interpret 
the data during treatment to learn the Subjects usual physiology prior to commencing study drug. 
A detailed manual (ePatch Acquisition Guide) describing affixation and removal of the device, 
and requirements for upload of recorded data will be provided and all site staff will be trained on 
the use of the ePatch device. 
7.1.2. 
Radiographic Assessments 
Details for the [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. 


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To avoid unnecessary radiation, it is recommended all other Screening activities need to be 
completed prior to PET scans for eligibility. In all cases, the lowest radiation dose approach for 
imaging should be used. Subjects will undergo up to 3 [18-F] FDG-PET/CT scans; cumulative 
radiation exposure from these scans will range from 22.2 mSv to 41.7 mSv, depending primarily 
on CT technique used. 
7.1.2.1. 
[18-F] Fluorodeoxyglucose-Positron Emission Tomography/Computed 
Tomography  
All subjects will undergo whole-body head to mid-thigh [18-F] FDG-PET/CT imaging with a 
reconstructed resolution of ≤5mm during Screening and at Week 34. Subjects in Cohort A will 
receive an additional scan at Week 22, and subjects in Cohort B will receive an additional scan at 
Week 10. Timepoints for imaging are specified in the SOA (Appendix 1). All subjects must 
adhere to a low carbohydrate/low calorie diet 24 hours prior to the PET scan; the treating 
Investigator should discuss the appropriate diet options with subjects, see Appendix 11 for diet 
recommendations. Details of the scan requirements and procedures are contained in the 
Participant Scanning Guide. At Screening, the scan may be interpreted locally to confirm 
evidence of disease activity consistent with active CS; however, all scans are subject to central 
read for the purposes of eligibility. Only central imaging interpretation will be accepted for 
eligibility determination.  
A PET/CT scan conducted as part of the usual clinical management of the subject 
(e.g. assessment for suspected CS) within 2 weeks prior to informed consent may be 
considered/assessed for use in place of the Screening PET/CT exam if the scan can be uploaded 
to the central imaging vendor for central read and the OCS dose has not changed in the 4 weeks 
prior to the scan. If this PET/CT scan is deemed unable to be assessed, is of insufficient quality 
on central read, or was performed more than 2 weeks prior to informed consent, the PET/ CT 
scan must be repeated and performed as part of screening, per protocol. The central read will 
determine final study eligibility compared to local interpretation. For subjects considered for 
inclusion into Cohort A, high-dose OCS may be commenced at any time after a potentially 
eligible PET/ CT scan has been performed including before informed consent (e.g. after 
diagnosis of CS, it may be likely to start high dose OCS as part of the usual care of CS, before 
entering into Screening and signing informed consent); however, if the OCS dose is changed to 
>10 mg/ day of prednisone (or equivalent), and the PET/CT scan needs to be repeated 
(i.e. performed as part of usual management and unable to be assessed or insufficient quality on 
central read) then the subject will be ineligible for inclusion. If the OCS dose commenced as part 
of usual care, before informed consent, is not within the protocol-defined range of 25-60 mg/ day 
prednisone (or equivalent), it should be adjusted to be within the protocol-defined range as soon 
as is practical after the subject has signed informed consent and no later than the time the subject 
is randomized/enrolled. 
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.  


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Screening, Week 10 (Cohort B only), Week 22 (Cohort A only), and Week 34 scans will be 
assessed as follows.   
• Change in the SUVmax – mean change from Baseline; 
• Mean change in SUVmean from Baseline; 
• Mean change in Total Glycosylation vs Baseline; 
• Mean change in SUVmax in extracardiac regions of interest; 
• Percentage lesion resolution rate in the cardiac and extracardiac regions of interest, to an 
SUV of 1.2 or less. For exploratory purposes, different sensitivity thresholds will be 
applied to define resolution. 
Total radiation exposure for study subjects will be minimized as far as possible as follows: 
•  [18-F] FDG-PET/CT scans should ideally be performed after subjects have completed 
other Screening requirement successfully; 
• Lowest dose of injectable radioisotope should be used per the guidance in the Participant 
Scanning Guide; 
• Poor quality scans will not be repeated for study purposes, unless indeterminate for study 
inclusion. 
Subjects will undergo up to 3 [18-F] FDG-PET/CT scans; cumulative radiation exposure from 
these scans will range from 22.2 mSv to 41.7 mSv, depending primarily on CT technique used. 
7.1.3. 
Patient-reported Outcomes 
The effect of namilumab on select PROs will be evaluated, see Appendix 9 for examples. The 
PROs used in this study include: 
• KSQ General Score and Sub-scores; 
• FAS; 
• SGA. 
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, study 
staff will collect the data and check for completeness only. 


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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. 
7.1.3.1. 
King’s Sarcoidosis Questionnaire 
The King’s Sarcoidosis Questionnaire (KSQ) is a modular, multi-organ health status measure for 
subjects with sarcoidosis for use in the clinic and the evaluation of therapies. The KSQ consists 
of 5 modules: General health status (10 items), Lung (6 items), Medication (3 items), Skin 
(3 items), and Eye (7 items). The General health status module is intended to be administered to 
all subjects with sarcoidosis. In addition to this, all subjects will also complete organ-specific 
modules if relevant to their condition. All subjects will complete General health, and Medication 
modules and self-select the Lung, Skin and Eye modules if they have relevant symptoms for 
these assessments (Patel, 2013). 
7.1.3.2. 
Fatigue Assessment Scale 
The Fatigue Assessment Scale (FAS) is a 10-item self-reported fatigue questionnaire. The 
reliability and validity of the FAS have been demonstrated in sarcoidosis subjects. Subjects 
indicate their responses on a 5-point scale (from 1 never to 5 always). Total scores on the FAS 
can therefore range from 10 to 50, with high scores indicating more fatigue. Changes from 
baseline can range therefore from -40 to +40 on follow-up (Michielsen, 2004). 
7.1.3.3. 
Subject Global Assessment 
The Subject Global Assessment (SGA) 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 is similar to the pain VAS scale, which 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). 
7.1.4. 
Other Reported Outcomes 
The effect of namilumab on other physician-reported outcomes (Appendix 10) will be evaluated. 
These physician-reported assessments will include: 
• Modified Glucocorticoid Toxicity Index (mGTI). 
A representative example of this assessment is included in Appendix 10. Subjects will complete 
these assessments via electronic tablet as per the times specified in the SOA (Appendix 1). 


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7.1.4.1. 
Modified Glucocorticoid Toxicity Index  
The mGTI is a composite measure of the changes in OCS toxicity measured at 3-month intervals 
across 11 domains and 23 items. For the purposes of this study, radiographic assessment of bone 
mineral density is not being performed; therefore, this item is not being assessed in the tool and 
the tool is termed “modified” for this study. The change in the total score is from −35 to +410 
with the exclusion of bone mineral density.  
The mGTI measures changes in OCS toxicity rather than the absolute GC toxicity in order to 
account for the effects of prior OCS therapy and the background rate of AEs. The mGTI will be 
completed at the timepoints specified in the SOA (Appendix 1) (Miloslavsky, 2017). 
7.2. 
Safety Assessments 
Planned timepoints for all safety assessments are provided in the SOA (Appendix 1). 
Assessments for safety include vital signs, height, and weight, PEs, ECGs, clinical laboratory 
assessments, and AEs. 
7.2.1. 
Vital Signs, Height, and Body Weight 
7.2.1.1. 
Vital Signs 
Vital signs (BP, heart rate, respirations, and temperature) will be measured after 5 minutes of 
rest, with the participant 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. 
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.  
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 participant. 
7.2.1.2. 
Height 
Standing height will be measured without shoes. 
7.2.1.3. 
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. 


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7.2.2. 
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. 
7.2.3. 
Electrocardiograms 
A single 12-lead ECG(s) will be obtained as outlined in the SOA (Appendix 1) using the 
study-specific ECG machine that automatically calculates the heart rate and measures PR, QRS, 
QT, and QTc intervals, and QRS complex. All scheduled ECGs should be performed after the 
participant has rested quietly for at least 10 minutes in a supine position and prior to any blood 
collections.  
When triplicate ECGs are required (e.g., at Screening only if the initial QTcF is >480 msec or as 
outlined in Section 4.4.2.5 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, and averaged together to make a determination. 
7.2.4. 
Chest Radiography 
A standard posterior-anterior and lateral chest x-ray should be performed at Screening as 
outlined in the SOA (Appendix 1). No study specific requirements based on x-ray are required 
for inclusion; however, subjects with abnormal radiographic findings inconsistent with the 
diagnosis of sarcoidosis or the subject’s past medical history and that warrant further 
investigation should be excluded.  
7.2.5. 
Spirometry 
Spirometry will be performed to determine the subject’s FEV1, ppFEV1, FVC, ppFVC, 
FEV1/FVC, and pFEV1/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 the SOA (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 


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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. 
7.2.6. 
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. A positive test 
on repeat requires that a subject commence appropriate anti-TB therapy prior to randomization 
as noted in Section 4.2. 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 as such a specialist) 
who determines that risk of infection is low (i.e., participant would be acceptable for 
immunosuppressant treatment without additional action or therapy). Such determination should 
be documented in the subject’s source record. 
7.2.7. 
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 an undetectable viral load by RT-PCR 
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.  
7.2.8. 
Clinical Safety Laboratory Assessments 
See Appendix 5 for the list of clinical laboratory tests to be performed for Screening and safety 
monitoring; see 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. New York State investigators will be blinded to the 
screening anti-GM-CSF auto-antibody laboratory results due to New York State regulations. 
These results will be made available to the New York State sites at the end of the trial. 


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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 
participant’s condition. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study or within approximately 4 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 participant management or are considered clinically 
significant by the Investigator (e.g., SAE or AE or dose interruption/discontinuation), then the 
results must be recorded. 
7.2.9. 
Cytokine and Chemokine Analyses 
The following will be tested according to the SOA (Appendix 1) using a commercially available 
testing panel: GM-CSF; IL-1α; IL-5; IL-7; IL-12/IL-23p40; IL-15; IL-16; IL-17A; TNF-β; 
vascular endothelial growth factor; Interferon gamma (IFN-γ); IL-10; IL-12(p70); IL-13; IL-1β; 
IL-2; IL-4; IL-6; IL-8; TNF-α; Eotaxin, MIP-1β, Eotaxin-3, thymus activation regulated 
chemokine (TARC), MIP-1α, Monocyte Chemoattractant Protein (MCP)-1, Macrophage Derived 
Chemokine (MDC), MCP-4, and 2 CXC (homeostatic) chemokine assays (IP-10, IL-8) (see 
Appendix 5).  
7.2.10. 
 Sarcoidosis Biomarkers 
The following will be tested according to the SOA (Appendix 1): soluble IL-2 receptor, and 
serum amyloid A with the inflammatory markers high-sensitivity CRP and erythrocyte 
sedimentation rate (ESR). A sample will be taken on the same sampling schedule for storage to 
assess at a future timepoint for additional biomarkers.  
7.2.11. 
Sample Requirements 
The maximum amount of blood (Table 6) collected from each subject over the duration of the 
study, including any extra assessments that may be required, will be approximately 250 mL. 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
 
 


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7.2.12. 
Pregnancy Testing 
WCBP 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 4.4.2.6 and Section 6.3, a 
negative pregnancy test result will be required at Day 1 (Baseline) prior to the subject receiving 
study drug and at subsequent visits where pregnancy testing is specified. Additionally, if the site 
staff become aware of a participant having a missed menstrual cycle between visits, the 
participant 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.  
Urine pregnancy tests (supplied by the central laboratory) will be performed at the site. 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. A positive urine β-hCG test during the 
study after randomization requires immediate interruption of study drug until a serum β-hCG is 
Table 6. 
Estimated Sample Requirements Per Subject 
 
Approximate sample 
volume per collection 
(mL) 
Number of collection 
timepoints 
Approximate total 
volume collected (mL) 
Clinical laboratory 
tests 
16.5 
11 
181.5 
QuantiFERON® 
Gold/IGRA 
11 
1 
11 
Anti-GM-CSF 
autoantibody 
2 
1 
2 
PK  
4 
5 
20 
ADA 
4 
3 
12 
Cytokine and 
chemokine panel 
8.5 
5 
42.5 
SP-D, SAA, and 
biomarkers 
5 
5 
25 
FSH (if necessary) 
3.5 
1 
3.5 
Virology labs 
(hepatitis B, 
hepatitis C, and 
HIV) 
5 
1 
5 
Total: 
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performed and found to be negative. The participant must be discontinued from the study and 
followed if pregnancy is confirmed by a positive serum β-hCG. 
7.3. 
Adverse and Serious Events 
7.3.1. 
Adverse Events 
AE definitions and assignment of severity and causality are detailed in Appendix 3. 
Non-serious AE collection will be initiated after the subject has been randomized/enrolled and 
continue to be collected through the follow up phone call visit. 
Any sign, symptom, or illness occurring prior to first dose of double-blind study drug will be 
captured in the medical history. TEAEs are defined as any AE reported after the first dose of 
study drug and continue to be collected through the follow up phone call visit. AE definitions 
and assignment of severity and causality are detailed in Appendix 3. 
AEs will be elicited from the subject (or, when appropriate, from a caregiver, delegate, 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 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). 
7.3.2. 
Reporting Serious Adverse Events 
All SAEs, occurring after the signing of the ICF until 56 days after the last dose of study drug, 
and regardless of study drug relationship, must be reported within 24 hours of becoming aware 
of the event to appropriate Sponsor/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. SAE definitions and assignment of severity 
and causality are detailed in Appendix 3. 
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.  
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: 


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SAEintake@labcorp.com. If email access is not available, the SAE may be reported via fax using 
the below regional numbers or by telephone hotline: 
US Fax# 1-888 887 8097 
Safety Hotline# 1-888-724-4908  
7.3.3. 
Pregnancy 
Although not considered an SAE (unless the event occurs with a serious outcome), pregnancy 
(Section 4.4.2.6) 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) within 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. 
7.4. 
Pharmacokinetic Analysis 
Predose blood samples will be collected into appropriately labeled tubes for measurement of 
namilumab plasma concentrations as specified in the SOA (Appendix 1) from all subjects who 
receive at least 1 dose of namilumab. 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 BA sample analysis plan) will be used to measure 
plasma concentrations of namilumab. 
7.5. 
Immunogenicity Assessment 
Blood samples will be collected based on the SOA (Appendix 1) from all subjects who receive at 
least 1 dose of namilumab. A specific bioassay to determine development of ADA will be 
performed using a tier approach, i.e., Screening, confirmatory, and titer assessment. The impact 
of ADA on the PK of namilumab will be assessed. 


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8. 
SAMPLE SIZE AND DATA ANALYSES 
This section outlines the statistical analysis strategy and procedures for the study.  
8.1. 
Determination of Sample Size 
The sample size for this study is not based on formal statistical calculations of study power. The 
planned sample size is considered sufficient to meet the primary objective. 
8.2. 
Analysis Populations 
The following analysis populations will be included for this study: 
8.2.1. 
Intent-to-treat Population 
The Intent-to-Treat (ITT) Population will include all randomized/enrolled subjects. 
8.2.2. 
Modified Intent-to-treat Population 
The modified ITT (mITT) Population will include all randomized/enrolled subjects who receive 
any amount of study drug. For analysis of endpoints defined as changes from baseline, subjects 
must also have at least 1 Baseline or post-baseline assessment. The mITT will be analyzed 
according to the treatment assigned. All efficacy analyses will be performed using the mITT 
Population. 
8.2.3. 
Per-Protocol Population 
The Per-Protocol (PP) Population will include all subjects in the ITT Population who have no 
major protocol violations. The PP Population will be used for sensitivity analyses of the efficacy 
measurements. 
8.2.4. 
Safety Population 
The Safety Population (SP) will include all randomized/enrolled subjects who receive any 
amount of study drug. The SP will be analyzed according to the treatment received. This set will 
be used for safety analyses. 
8.3. 
General Considerations 
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 standard deviation (SD) will be summarized. Categorical variables will be described 
by the count and proportion in each category. 
8.4. 
Handling of Missing Data 
Missing data will not be imputed for safety or efficacy assessment. The reasons of missing data, 
including lost to follow-up, SAEs/AEs, and any other causes, will be identified, and the 
percentage of these subjects will be summarized by treatment. Large proportions of missing data 
may introduce bias, particularly if they are imbalanced between treatment groups. Possible bias 
due to missing data will be explored with sensitivity analysis. 


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More details will be pre-specified in the statistical analysis plan (SAP). 
8.5. 
Efficacy Analyses 
Efficacy analysis will be performed separately for subjects in Cohort A and subjects in Cohort B. 
No hypothesis testing is planned for efficacy endpoints analyses. Nominal p values for treatment 
comparisons in efficacy analysis (Cohort A) will be provided as descriptive measures and should 
not be interpreted as conclusive evidence. 
8.5.1. 
Efficacy Analysis Approaches  
For continuous efficacy endpoints, summary statistics such as means, medians, and SDs will be 
provided by treatment groups. Model-based LS means and confidence intervals (CIs) for within 
treatment estimates and between treatment differences (Cohort A) will also be provided.  
Categorical efficacy endpoints will be summarized by treatment with counts and percentages of 
the subjects. CIs for within treatment estimate and between treatment differences (Cohort A) will 
also be provided. 
Time to event endpoints will be summarized using the Kaplan-Meier method. 
Details for efficacy analysis methodologies will be provided in the SAP. 
8.5.2. 
Adjustment of Multiple Comparisons 
No hypothesis testing is planned for the study; therefore, adjustment for multiple comparisons 
will not be needed.  
8.6. 
Safety Analyses 
Safety analysis will be performed separately for subjects in Cohort A and Cohort B, as well as 
pooled across Cohorts A and B. 
Safety variables include incidence of AEs or TEAEs, laboratory test results, vital signs, ECG 
results, and PE findings. 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 analysis of the safety data will be performed. 
Summary tables will be provided for all AEs by treatment group. The incidence of AEs, 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 1 episode of a particular AE, the subject will be counted only once for that event. Similarly, 
if a subject has more than 1 AE within an 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). Shift tables (low, normal, high) 
between Baseline and post-baseline timepoints will be presented by laboratory test and treatment 


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group. Laboratory tests with categorical results that cannot be analyzed by change from baseline 
or shift table analysis will not be included in these summaries but will be listed. 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 treatment 
groups. PE findings will be listed for each subject. 
Full details will be described in the Statistical Analysis Plan (SAP.) 
8.7. 
Population Pharmacokinetic Analysis 
The PPK and E-R analyses will be performed based on modeling analysis plan (MAP) and 
reported separately from the final clinical study report. The MAP will be submitted to the Food 
and Drug Administration (FDA) prior to unblinding subject data for analysis. 
8.8. 
Statistical Analysis Plan 
A detailed SAP will be signed and submitted to the FDA prior to database lock. 
8.9. 
Interim Analysis 
No formal interim analysis is planned. The DMC will be responsible for closely reviewing the 
unblinded safety data and for providing their recommendations. The detailed objectives and 
procedures will be described in the DMC Charter. 


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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):453-462.  
Baughman RP, Grutters JC. 2015. New treatment strategies for pulmonary sarcoidosis: 
antimetabolites, biological drugs, and other treatment approaches. Lancet Respir Med. 
3(10):813-822.  
Baughman RP, Field S, Costabel U, Crystal RG, Culver DA, et al. 2016. Sarcoidosis in America: 
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BMC Pulm Med. 15:11 
 


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APPENDIX 1. SCHEDULE OF ASSESSMENTS 
Schedule of Assessments 
Study Period 
Screen 
Treatment Period 
 FUa 
Visit # (V) 
V1 
Baseline 
V2 
V3 
 
V4-6 a 
V7 
 
V8-10 a 
V11 
 
V12-14 a 
V15 
 
V16-18 a 
V19 
 
V20-22 a 
V23 
V24 
V25 
EOT/ 
ET b 
V26 
EOS 
FU c 
V27 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7-9 
W10 
W11-13 
W14 
W15-17 
W18 
W19-21 
W22 
W26 
W30 
W34 
W38 
Study Day (D) 
[Window based 
on Day 1 Visit] 
D -42 
to -1 
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] 
D134, 
D141, & 
D148 
[±3] 
D155 
[±3] 
D183 
[±3] 
D211 
[±3] 
D238 
[±3] 
295 
[±7] 
Informed 
consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic 
information 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior 
medicationsd 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
examinatione 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
Height and 
weightf 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Vital signs 
(blood pressure 
[sitting], heart 
rate, respiration 
rate, and body 
temperature)g 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
Heart rhythm 
monitoring 
(wearable)h 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
 


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Schedule of Assessments 
Study Period 
Screen 
Treatment Period 
 FUa 
Visit # (V) 
V1 
Baseline 
V2 
V3 
 
V4-6 a 
V7 
 
V8-10 a 
V11 
 
V12-14 a 
V15 
 
V16-18 a 
V19 
 
V20-22 a 
V23 
V24 
V25 
EOT/ 
ET b 
V26 
EOS 
FU c 
V27 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7-9 
W10 
W11-13 
W14 
W15-17 
W18 
W19-21 
W22 
W26 
W30 
W34 
W38 
Study Day (D) 
[Window based 
on Day 1 Visit] 
D -42 
to -1 
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] 
D134, 
D141, & 
D148 
[±3] 
D155 
[±3] 
D183 
[±3] 
D211 
[±3] 
D238 
[±3] 
295 
[±7] 
12-lead ECGi 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
Chest X-ray 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FDG-PET CT 
scanj 
X 
 
 
 
 
 
X 
(Cohort 
B only) 
 
 
 
 
 
X (Cohort 
A only) 
 
 
X 
 
ECHO 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
Pulmonary 
function tests 
(FEV1, 
FEV1/FVC, and 
FVC) 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
PROs (KSQ, 
FAS, and SGA) 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
mGTI 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
Recording of 
steroid dose and 
rescue therapy 
usek 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant 
medication/ 
concurrent 
proceduresl 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serious adverse 
event 
monitoringm 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 


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Schedule of Assessments 
Study Period 
Screen 
Treatment Period 
 FUa 
Visit # (V) 
V1 
Baseline 
V2 
V3 
 
V4-6 a 
V7 
 
V8-10 a 
V11 
 
V12-14 a 
V15 
 
V16-18 a 
V19 
 
V20-22 a 
V23 
V24 
V25 
EOT/ 
ET b 
V26 
EOS 
FU c 
V27 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7-9 
W10 
W11-13 
W14 
W15-17 
W18 
W19-21 
W22 
W26 
W30 
W34 
W38 
Study Day (D) 
[Window based 
on Day 1 Visit] 
D -42 
to -1 
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] 
D134, 
D141, & 
D148 
[±3] 
D155 
[±3] 
D183 
[±3] 
D211 
[±3] 
D238 
[±3] 
295 
[±7] 
Adverse event 
monitoringm 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
TB test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Viral screen 
(Hep B, Hep C, 
HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH (women 
only & if 
indicated)n 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample for anti 
GM-CSF 
autoAbq 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample for 
ADA 
(antibodies to 
namilumab)o 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Cytokine and 
chemokine 
samples 
 
X 
 
 
 
 
X 
 
X 
 
 
 
 
X 
 
X 
 
Samples for 
hsCRP, SAA, 
sarcoid 
biomarkers, and 
SP-D 
measurement 
 
X 
 
 
 
 
X 
 
X 
 
 
 
 
X 
 
X 
 


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Schedule of Assessments 
Study Period 
Screen 
Treatment Period 
 FUa 
Visit # (V) 
V1 
Baseline 
V2 
V3 
 
V4-6 a 
V7 
 
V8-10 a 
V11 
 
V12-14 a 
V15 
 
V16-18 a 
V19 
 
V20-22 a 
V23 
V24 
V25 
EOT/ 
ET b 
V26 
EOS 
FU c 
V27 
Week (W) 
W -6 
W0 
W2 
W3-5 
W6 
W7-9 
W10 
W11-13 
W14 
W15-17 
W18 
W19-21 
W22 
W26 
W30 
W34 
W38 
Study Day (D) 
[Window based 
on Day 1 Visit] 
D -42 
to -1 
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] 
D134, 
D141, & 
D148 
[±3] 
D155 
[±3] 
D183 
[±3] 
D211 
[±3] 
D238 
[±3] 
295 
[±7] 
Clinical 
laboratory: 
hematology 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
Clinical 
laboratory: 
blood chemistry 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
Clinical 
laboratory: 
urinalysis 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
HbA1C 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
Vitamin D 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
NT-proBNP 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
Troponin 
 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
Urine pregnancy 
test β-hCG 
(WCBP only) 
X 
X 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
X 
 
PK samplep 
 
 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
X 
 
Randomization 
and/or treatment 
assignment 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Administration 
of study drug 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
Abbreviations: β-hCG = beta human chorionic gonadotropin, ADA = anti-drug antibodies, CT = computed tomography, ECG = electrocardiogram, ECHO = echocardiogram, 
EOS = End-of-Study, EOT = End-of-Treatment, ET = early termination, FAS = Fatigue Assessment Scale, FDG = fluorodeoxyglucose, FSH = follicle-stimulating hormone, 
FU = Follow-up Visit, GM-CSF autoAb = granulocyte macrophage colony-stimulating factor autoantibody, HbA1C = glycosylated hemoglobin, Hep = hepatitis, HIV = human 
immunodeficiency virus, hsCRP = high-sensitivity C-reactive protein, KSQ = King’s Sarcoidosis Questionnaire, mGTI = modified glucocorticoid toxicity index, 


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NT-proBNP = N-terminal (NT)-proB-type natriuretic peptide, PET = positron emission tomography, PK = pharmacokinetic, PRO = patient-reported outcome, SAA = serum 
amyloid A, SGA = Subject Global Assessment, SP-D = serum surfactant protein D, TB = tuberculosis, WCBP = woman of childbearing potential. 
a. 
The Investigator will conduct weekly FU (via phone, telemed, or any site-approved remote method). 
b. Subjects who withdraw or are withdrawn from the study early will undergo all Week 34 ET/EOT Visit procedures whenever possible. 
c. 
The FU will be a phone call approximately 8 weeks (56 days) following the last dose of study drug. 
d. 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. 
e. 
A full physical examination will be performed at Screening and the EOT/ET Visit; an abbreviated targeted physical examination will be performed at all other clinic 
Visits. 
f. 
Height will be measured at Screening only; weight will be measured at all indicated timepoints. 
g. Vital signs will be assessed at all timepoints specified above. On study drug administration days, vital signs will be assessed predose (within 15 minutes) and ±30 minutes 
post-dose. 
h. Subjects will be monitored via ePatch for 10 consecutive days; one patch will be worn for 5 days, then the patch will be replaced by the subject, and the second patch will 
be worn for an additional 5 days.  
i. 
A single 12-lead standard ECG will be recorded at all timepoints specified above. 
j. 
Only central imaging interpretation will be accepted for eligibility determination. Scans conducted as part of the usual clinical management of the subject within 2 weeks 
prior to informed consent may be considered/assessed for use in place of the Screening PET/CT scan if the scans can be uploaded to central imaging vendor for central 
read and the OCS dose has not changed in the 4 weeks prior to the scan. Refer to Section 7.1.2.1 for details 
k. Document whether the patient has completed taper by the specified timepoints described in Appendix 8 or whether a dose increase/maintenance was needed. See 
Section 6.4 for more details regarding rescue therapy. Patients should record OCS dose daily on provided eDiary. 
l. 
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. All medications and procedures prior to randomization should be listed in the subject’s medical history. 
m. All serious adverse events will be monitored and collected from the time of informed consent through the 8 weeks (56 day) post last dose of study drug FU. All adverse 
events will be monitored and collected from the time of randomization through the 8 weeks (56 day) post last dose of study drug FU. Treatment-emergent adverse events 
will be those that start or change in severity after the first dose of study drug. 
n. If necessary, follicle-stimulating hormone will be measured at Screening to confirm postmenopausal status. 
o. The ADA samples will be collected at Baseline (prior to the first dose) of Day 1 (Week 0), at Week 14, and at EOT. For subjects who terminate the study early, one ADA 
sample will be collected before discharging, when possible. Actual sampling time will be recorded. 
p. The PK samples will be collected prior to study drug administration at the appropriate timepoints and actual sampling time will be recorded. 
q. Investigators in the state of New York will remain blinded to the anti-GMCSF auto-antibody assay results until the end of the trial due to regulations within the state of 
New York. 
 


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APPENDIX 2. HEART RHYTHM SOCIETY DIAGNOSTIC CRITERIA 
BASED ON 2 DIAGNOSTIC PATHWAYS 
1. Histological diagnosis from myocardial tissue - cardiac sarcoidosis (CS) is diagnosed in 
the presence of non-caseating granuloma on histologic examination of myocardial tissue 
with no alternative cause identified (including negative stain for microorganisms, as 
applicable). Note this criterion is not required for this trial. 
2. Clinical diagnosis from invasive and/or non-invasive studies: it is probable that there is 
CS if (a) through (c) are satisfied: 
a) Histological diagnosis of extracardiac sarcoidosis 
b) One or more of the following: 
• 
Steroid ± immunosuppressant responsive cardiomyopathy or heart block 
• 
Unexplained reduction in LVEF (<40%) 
• 
Unexplained sustained (spontaneous or induced) ventricular tachycardia 
• 
Mobitz type II 2nd degree or 3rd degree AV block 
• 
Patchy uptake on dedicated cardiac PET in a pattern consistent with CS (PET 
SUVmax ≥3, as required in the inclusion criteria) 
• 
Late gadolinium enhancement on cardiac magnetic resonance (in a pattern 
consistent with CS) 
• 
Positive gallium uptake (in a pattern consistent with CS) 
c) Other causes for the cardiac manifestation(s) have been reasonably excluded. 


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APPENDIX 3. ADVERSE EVENT DEFINITIONS AND REPORTING 
Adverse event (AE) reporting begins from the time the first dose of study drug has been taken 
and ends 8 weeks (56 days) after the last dose of study drug. 
Definitions: 
An AE is any untoward medical occurrence temporally 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 ICF 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: 
At each visit, the Investigator, or delegate, will determine whether or not 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: 


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SAE reporting begins from the time of informed consent and ends 8 weeks (56 days) after the 
last dose of study drug. 
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 AE 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. 
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 
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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 4-category system according to the following guidelines: 
• Not Related: when the AE/SAE 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. 
Action Taken for Adverse Events: 
The Investigator or designee will record the action taken for the AE in the eCRF. Actions taken 
will include: 


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• Dose increased: The medication schedule was modified by addition, either by changing 
the frequency, strength, or amount; 
• Dose not changed: The medication schedule was not changed; 
• Dose reduced: The medication schedule was modified by subtraction, either by changing 
the frequency, strength, or amount; 
• 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; 
• Not applicable; 
• Unknown. 
Follow-up of Adverse Events: 
All (S)AEs that are ongoing at the time of discontinuation, or that develop prior to the final 
follow-up telephone call, will be followed for 56 days, 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). 


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APPENDIX 4. COMPARISON OF SYSTEMIC GLUCOCORTICOID 
PREPARATIONS 
Glucocorticoids 
Equivalent doses (mg) 
Duration of action (hours) 
Short Acting 
 
 
• Cortisone 
25 
8 to 12 
• Hydrocortisone 
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, 2021) 


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APPENDIX 5. CLINICAL LABORATORY EVALUATIONS 
The following clinical laboratory analytes will be assessed as timepoints specified in the SOA 
(Appendix 1). 
Blood Chemistry 
 
Serology 
-Albumin 
-ALP 
-ALT 
-AST 
-BUN 
-Calcium (absolute, 
corrected) 
-Creatinine 
-eGFR 
-GGT 
-Glucose 
-High-sensitivity CRP  
 
-LDH 
-Phosphorus 
-Potassium 
-Sodium 
-SP-D (Surfactant Protein D) 
-Total Bilirubin (total and 
direct) 
-Total CO2 (measured as 
bicarbonate) 
-Total Protein 
-Uric Acid 
 
-anti-GM-CSF  
-ADAs (to namilumab) 
-HBcAb 
-HBsAb 
-HBsAg 
-HCVab 
-Hep B (reflex testing if applicable) 
-Hep C (reflex testing if applicable) 
-HIVAb 
-RT-PCR (if applicable, based on serology results) 
Hematology 
 
Urinalysis 
-ESR 
-Hematocrit 
-Hemoglobin 
-MCH 
-MCHC 
-MCV 
-Platelet count 
-Red blood cell (RBC) 
count 
-Reticulocytes  
(%, absolute) 
-White blood cell (WBC) 
count 
-WBC Differential  
(%, absolute) including:  
   -Basophils 
   -Eosinophils 
   -Monocytes 
   -Neutrophils 
   -Lymphocytes 
 
 
-Bilirubin 
-Color and appearance 
-Urine pregnancy test (for WCBP only) 
-Glucose 
-Ketones 
-Leukocyte esterase 
-Microscopic (including RBCs and WBCs) 
-Nitrate 
-Occult blood 
-pH and specific gravity 
-Protein 
Lipid Profile 
 
Other Assessments & Biomarkers 
-Total cholesterol (TC) 
-Triglycerides (TGs) 
-High-density lipoprotein cholesterol (HDL-C) 
-Low-density lipoprotein cholesterol (LDL-C) 
 
-FSH (as indicated to confirm postmenopausal status) 
-HbA1C 
-IGRA (QFT-G) 
-SAA 
-Soluble IL2 Receptor (SIL2R) 
-25-hydroxyvitamin D (serum)  
-1,25-dihydroxyvitamin D (serum) 
-NT-proBNP 
-Troponin I  
 
Cytokine and Chemokine Analyses 
-GM-CSF 
-IL-1α 
-IL-1β 
-IL-2 
-IL-4 
-IL-5 
-IL-6 
-IL-7 
-IL-8 
-IL-12/IL-23p40 
-IL-15 
-IL-16 
-IL-17A 
-IL-10 
-IL-12(p70) 
-IL-13 
-IP-10 
-TNF-α 
-TARC 
-TNF-β 
-VEGF 
-IFN-γ 
-Eotaxin, MIP-1β 
-Eotaxin-3 
-MCP-1 
-MCP-4 
-MDC 
-MIP-1α 
-CXC (homeostatic) 


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APPENDIX 6. 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 ICH GCP Guidelines; 
• Applicable laws and regulations. 
The protocol, protocol amendments, ICF, Investigator’s Brochure, and other relevant documents 
(e.g., advertisements) must be submitted to an IRB by the Investigator and reviewed and 
approved by the IRB before the study is initiated. 
• Any amendments to the protocol will require IRB 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 annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB; 
• Notifying the IRB of SAEs or other significant safety findings as required by IRB 
procedures; 
• Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 CFR, ICH guidelines, the IRB, and all other applicable local regulations. 
Finances and Insurance 
Financing and insurance will be addressed in a separate agreement. 
Informed Consent 
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 or their legally authorized representative will be required to sign a statement of 
informed consent that meets the requirements of local regulations, ICH guidelines, and the IRB 
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. 


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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 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. The subject must also be informed that his/her medical records may be 
examined by Sponsor or CRO auditors or other authorized personnel appointed by the Sponsor, 
by appropriate IRB members, and by inspectors from regulatory authorities. 
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. 
Data Quality Assurance 
The following data quality steps will be implemented: 
• 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 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; 


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• 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). 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, PK, pharmacodynamics, ECG 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. 
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. Unless otherwise specified in the clinical study agreement, 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. 
 


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APPENDIX 7. LIVER SAFETY SUGGESTED ACTIONS AND 
FOLLOW-UP ASSESSMENTS 
Phase 2 liver function stopping criteria are designed to ensure subject safety and to evaluate liver 
event etiology. 
Phase 2 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 international normalized ratio (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 within 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. 
• 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 PK analysis obtained after 
the most recent dose.5 
• Serum creatine phosphokinase and lactate 
dehydrogenase.  
• 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. 


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MONITORING: 
For bilirubin or INR criteria: 
Repeat liver function tests (include ALT, AST, ALP, 
bilirubin) and perform liver function follow-up 
assessments within 24 hours. 
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, ALP, 
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 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 CT) 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; HBsAg and HBcAb; hepatitis C ribonucleic acid; 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. 
 
 
 


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Phase II Liver Function Increased Monitoring Criteria with Continued Therapy 
 
Liver Function Increased Monitoring Criterion and Follow-up 
Criterion 
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 within 24 hours of 
learning of the abnormality to discuss subject safety. 
• Subject can continue study treatment. 
• Subject must return weekly for repeat liver function tests 
(ALT, AST, ALP, 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. 
• 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. 
 
 


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APPENDIX 8. ORAL CORTICOSTEROID TAPERING PROTOCOL 
Only Subjects enrolled in Cohort A will receive high dose OCS and undertake and follow the 
steroid taper. All subjects will be commenced at a dose of 25 to 60 mg of prednisone daily or its 
equivalent. The high dose steroid treatment may start as soon as the screening PET scan has been 
completed or up until the Baseline visit/ day of randomization. The investigator will determine 
the starting dose of OCS. 
Prednisone or equivalent tapering schedule 
Weeks 1-4 
Maintain 25 mg/day or reduce from up to 60 mg/day to 25 mg/day by Week 4 (per Investigator’s 
determination). 
In all cases by the Week 4 Visit, the subject should be receiving 25 mg of prednisone or 
equivalent daily. For subjects receiving >25 mg daily of prednisone or its equivalent initially, the 
investigator must agree the doses to be received between commencing high-dose OCS treatment 
and the Week 4 visit and confirm via the planned phone visits (Appendix 1) that the subject is 
taking their OCS as intended. Irrespective of the dose of OCS received all subjects should have 
phone visits to ensure their adherence to the intended OCS dose and to assess for (S)AEs. 
Weeks 5-10 
Maintain 25 mg/day 
Following the Week 4 Visit through the Week 10 Visit, all subjects should receive 25 mg per day 
of prednisone or its equivalent. 
Weeks 11-22 
Taper to 10 mg/day by Week 22 
Following the Week 10 Visit, subjects should commence the steroid taper with the goal of 
receiving no more than 10 mg of prednisone daily (or equivalent) by the Week 22 Visit. The 
precise dose on a day by day and week by week basis will be determined by the Investigator and 
Subject compliance is to be assured at the phone follow up visits. 
Weeks 22-34 
Following the Week 22 Visit, subjects will receive 10 mg or less of prednisone daily (or its 
equivalent); based on the opinion of the Investigator. Further dose reduction below 10 mg of 
prednisone daily or its equivalent is encouraged if the clinical situation allows but 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 3.1.4.1). 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 rescue based 
on clinical judgement. 


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APPENDIX 9. PATIENT-REPORTED OUTCOMES ASSESSMENTS 
Examples of the following patient-reported outcomes (PROs) are provided in this appendix: 
• Kings Sarcoidosis Questionnaire 
• Fatigue Assessment Scale 
• Subject Global Assessment 
 
 
 


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King’s Sarcoidosis Questionnaire 
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 
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 
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 
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 


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Medication 
In the last 2 weeks... 
A huge 
amount 
A 
considerable 
A moderate 
amount 
A modest 
amount 
A small 
amount 
A tiny 
amount 
None at all 
17 
I have worried about the side effects of my 
medication for sarcoidosis 
1 
2 
3 
4 
5 
6 
7 
18 
I have felt worse because of my medication 
1 
2 
3 
4 
5 
6 
7 
19 
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 
A moderate 
amount 
A modest 
amount 
A small 
amount 
A tiny 
amount 
None at all 
20 
I have been bothered by my skin problems 
1 
2 
3 
4 
5 
6 
7 
21 
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 
22 
I have been embarrassed about my skin 
1 
2 
3 
4 
5 
6 
7 
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 
23 
I have had dry eyes 
1 
2 
3 
4 
5 
6 
7 
24 
I have had difficulty with bright lights 
1 
2 
3 
4 
5 
6 
7 
25 
My eyes have been red 
1 
2 
3 
4 
5 
6 
7 
26 
I have had pain in/or around the eyes 
1 
2 
3 
4 
5 
6 
7 
27 
I have had difficulty reading 
1 
2 
3 
4 
5 
6 
7 
 


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In the last 2 weeks... 
A huge 
amount 
A 
considerable 
A moderate 
amount 
A modest 
amount 
A small 
amount 
A tiny 
amount 
None at all 
28 
I have had blurred vision 
1 
2 
3 
4 
5 
6 
7 
29 
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 
 


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Fatigue Assessment Scale (FAS) 
 
References: 
1. Drent M, Lower EE, De Vries J. Sarcoidosis-associated fatigue. Eur Respir J 2012; 40: 255–263. http://www.ncbi.nlm. 
nih.gov/pubmed/22441750 
2. Kleijn WPE, De Vries J, Wijnen PAHM, Drent M. Minimal (clinically) important differences for the Fatigue Assessment 
Scale in sarcoidosis. Respir Med 2011; 105: 1388-95. http://www.ncbi.nlm.nih.gov/pubmed/21700440 
3. De Vries, Michielsen H, Van Heck GL, Drent M. Measuring fatigue in sarcoidosis: the Fatigue Assessment Scale (FAS). 
Br J Health Psychol 2004; 9: 279-91. http://www.ncbi.nlm.nih.gov/pubmed/15296678 
4. Hendriks C, Drent M, Elfferich M, De Vries J. The Fatigue Assessment Scale (FAS): quality and availability in sarcoidosis 
and other diseases. Curr Opin Pulm Med 2018; 24 (5): 495-503. https://pubmed.ncbi.nlm.nih.gov/29889115 
 
© ild care foundation; www.ildcare.nl; usage is only allowed with the permission of the ild care foundation: info@ildcare.nl. 
 
 


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Subject Global Assessment 
Over the last two weeks, please rate how frequently you experienced sarcoidosis symptoms 
(coughing, breathlessness, dizziness, palpitations, chest pain/tightness or other ways your 
sarcoidosis affects you): 
 
None of the 
time 
A little of the time 
Some of the 
time 
Most of the time 
All of the time 
☐ 
☐ 
☐ 
☐ 
☐ 
 
Over the last two weeks, please rate how severe your sarcoidosis symptoms (coughing, 
breathlessness, dizziness, palpitations, chest pain/tightness or other ways your sarcoidosis affects 
you) have been: 
 
None 
Mild 
Moderate 
Severe 
Very Severe 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
 


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APPENDIX 10. OTHER REPORTED OUTCOMES 
Modified Glucocorticoid Toxicity Index  
 
 
 
 


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APPENDIX 11. DIET PREPARATION RECOMMENDATIONS FOR 
SUBJECTS 24 HOURS PRIOR TO PET SCAN 
 
PET/CT Preparation – For 24 hours before the scan 
 
• 
Do not exercise 
• If you are diabetic, get instructions from your physician 
• Follow a low carbohydrate diet (no pasta, bread, rice, potatoes, beans, cereal, desserts, 
candy, fruits, jam/jelly, honey, shakes/smoothies, etc.) 
• Do not consume dairy products (milk, yogurt, sour cream, soft cheeses) 
• Do not consume sugar or artificial sweeteners 
• Do not drink alcohol 
 
Foods you CAN eat: 
 
• Eggs 
• Leafy-green vegetables 
o Oil and lemon or vinegar dressing (nothing sweet) 
• Fried or broiled fish or meats seasoned with salt and pepper (nothing sweet) 
• Hard cheeses 
• Nuts, nut milk (e.g. almond milk), and UNSWEETENED nut butter 
 
PET/CT Preparation – Day of the scan 
 
• 
Medications 
o Take routine medications with PLAIN, UNFLAVORED WATER 
o If you need pain or anxiety medication, take it at least 1 hour before the scan 
• If you are diabetic, let your doctor and the staff at the scanner know 
o Your blood sugar will be checked 
• DO NOT EAT ANYTHING, including gum, breath mints, cough drops, or candy, FOR 6 
HOURS BEFORE THE SCAN 
o Drink only water 
• Do not wear metal zippers or jewelry of any kind 
 
• When your scan is completed, you will be able to go home and resume normal activities 
and diet 
Note: These are the minimum required recommendations, if the Investigator or site guidelines 
are more stringent or detailed, they supersede these recommendations.