A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy
Phase: PHASE2
Conditions: Asthma
Sponsor: RAPT Therapeutics, Inc.

Sponsor Name: RAPT Therapeutics, Inc. 
Protocol Number: RPT193-03 
Version and Date: Amendment 2, 12Sep2023 
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CLINICAL STUDY PROTOCOL 
 
Title: 
A Phase 2 study to evaluate the efficacy and safety of RPT193 in 
adults with moderate-to-severe T2-high asthma who are partially 
controlled on inhaled corticosteroid and long-acting beta 2 agonist 
therapy 
Protocol number:  
RPT193-03 
Study phase:  
Phase 2 
Test product:  
RPT193 
Regulatory agency 
identifier number(s): 
IND Number: 161880 
EU CT Number: 2022-502854-16-00  
Sponsor:  
RAPT Therapeutics, Inc. 
561 Eccles Avenue 
South San Francisco, CA 94080 
United States 
Protocol version and 
date:  
Amendment 2– 12Sep2023 
 
 
 
 
 
 
 
This study will be performed in compliance with the principles of Good Clinical Practice. 
This document is a confidential communication of RAPT Therapeutics, Inc. Acceptance of this 
document constitutes agreement by the recipient that no unpublished information contained 
herein shall be published or disclosed without prior written approval, except that this document 
will be disclosed to the appropriate Institutional Review Board(s)/Independent Ethics 
Committee(s) under the condition that they keep it confidential. 

Sponsor Name: RAPT Therapeutics, Inc. 
Protocol Number: RPT193-03 
Version and Date: Amendment 2, 12Sep2023 
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PROTOCOL SIGNATURE PAGE – COORDINATING INVESTIGATOR 
I agree to conduct this study according to this protocol and to comply with its requirements, 
subject to ethical and safety considerations and guidelines, and to conduct the study in 
accordance with the Declaration of Helsinki, International Council for Harmonisation guidelines 
on Good Clinical Practice (ICH GCP), and applicable regional regulatory requirements. 
Coordinating Investigator: 
 
 
 
 
Print Name 
 
 
Title 
 
Institution 
 
 
 
Signature 
 
Date 

Sponsor Name: RAPT Therapeutics, Inc. 
Protocol Number: RPT193-03 
Version and Date: Amendment 2, 12Sep2023 
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PROTOCOL SIGNATURE PAGE – INVESTIGATOR 
I have read this protocol, which has been agreed by RAPT Therapeutics, Inc. and given 
approval/favorable opinion by the IRB/IEC, and I agree that it contains all necessary details for my staff 
and me to conduct this study as described. I will provide copies of the protocol and any amendments to all 
study personnel under my supervision and provide access to all information provided by 
RAPT Therapeutics, Inc. or their specified designees. I will discuss the material with the study personnel 
to ensure that they are fully informed about the study. 
I understand that information contained in or pertaining to this protocol is confidential and should not be 
disclosed, other than to those directly involved in the execution or the ethical review of the study, without 
written authorization from RAPT Therapeutics, Inc. It is, however, permissible to provide information to 
a subject in order to obtain consent. 
I agree to conduct this study according to this protocol and to comply with its requirements, subject to 
ethical and safety considerations and guidelines, and to conduct the study in accordance with the 
Declaration of Helsinki, International Council for Harmonisation guidelines on Good Clinical Practice 
(ICH GCP), and applicable regional regulatory requirements. 
I agree to comply with the procedures described for data recording and reporting and to permit monitoring 
and auditing by RAPT Therapeutics, Inc., and inspection by the appropriate regulatory authorities. 
I agree to make my subjects’ study records available to RAPT Therapeutics, Inc. personnel, their 
representatives, and relevant regulatory authorities in order to verify data that I have entered into the 
electronic case report forms (eCRFs). I will retain the study-related essential documents until 
RAPT Therapeutics, Inc. indicates that they are no longer needed. I am aware of my responsibilities as an 
Investigator as provided by RAPT Therapeutics, Inc. 
I understand that RAPT Therapeutics, Inc. may decide to suspend or prematurely terminate the study at 
any time for whatever reason; such a decision will be communicated to me in writing. Conversely, should 
I decide to withdraw from execution of the study, I will communicate my intention immediately in 
writing to RAPT Therapeutics, Inc. 
Investigator: 
 
 
 
Print Name 
 
Title 
 
Institution 
 
 
 
Signature 
 
Date 

Sponsor Name: RAPT Therapeutics, Inc. 
Protocol Number: RPT193-03 
Version and Date: Amendment 2, 12Sep2023 
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ii. Female subject who has had a cessation of menses for at least 12 months prior to the Screening visit 
without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming 
nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels). 
b. Subjects must have been on a stable regimen of hormonal contraceptives for at least 4 weeks prior to 
Baseline. 
c. 
The above list of contraceptive methods does not apply to subjects who are abstinent for at least 
4 weeks before Baseline (Day 1) and will continue to be abstinent from penile-vaginal intercourse 
throughout the study. 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. 
d. For countries where double barrier methods are not accepted as highly effective contraception, then this 
option must not be considered. 
12. Female subject agrees to not have egg retrieval during the study and for 30 days after the last IP 
administration. 
13. For male subject involved in any sexual intercourse that could lead to pregnancy, subject must agree to use 
1 of the highly effective contraceptive methods listed in Inclusion Criterion #11 from Baseline (Day 1) until 
at least 90 days after the last IP administration. If the female partner of a male subject uses any of the 
hormonal contraceptive methods listed above, this contraceptive method should be used by the female 
partner from at least 4 weeks before Baseline (Day 1) until at least 90 days after the last IP administration. 
14. Male subject agrees not to donate sperm during the study and for 90 days after the last IP administration. 
15. Subject is willing to participate and is capable of giving informed consent. 
Note: Consent must be obtained prior to any study-related procedures. 
Exclusion Criteria 
1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. 
2. History of smoking per age group as follows (see also Exclusion Criterion #3): 
a. 
< 30 years old: Smoked for ≥ 5 pack-years.* 
b. 30 to 39 years old (inclusive): Smoked for ≥ 10 pack-years. 
c. 
≥ 40 years old: Smoked for ≥ 15 pack-years. 
*One pack-year of cigarettes is defined as 1 pack of cigarettes a day for 1 year and is equivalent to: 
• 
1 cigar or pipe per day for 1 year. 
• 
1 hookah or shisha smoking session per day for 1 year. 
• 
0.5 mL e-liquid per day for 1 year or 1 cartridge/tank/pod per day for 1 year of vaped e-cigarettes. 
• 
1 use of smoked marijuana per day for 1 year. 
3. Active use of any inhalant >1 time weekly in the past year including: 
a. 
Active smoking of conventional tobacco, marijuana (in any inhaled form) or other drugs, or vaping of 
e-cigarettes or e-devices. 
b. Other forms of tobacco including: 1 cigarette, 1 hookah or shisha session, 1 cigar, or 1 pipe. 
Note: Subjects must agree to refrain from using any inhalant as noted above more than 1 time weekly 
from the time they provide written informed consent until they complete all safety follow-up visits 
(ie, Day 141 / Week 20). 
4. Subject has any serious and/or uncontrolled medical condition (including cognitive impairment, 
alcohol/drug abuse, or signs/symptoms suspicious for a serious disease) or laboratory abnormality that 
would place subject’s safety at risk or interfere with study participation, as judged by the Investigator. 
5. Conditions that may mimic asthma (eg, vocal cord dysfunction, hyperventilation, panic attacks, cardiac 
asthma, uncontrolled gastroesophageal reflux disease). 
6. Subject has a history of severe COVID-19 that required intensive care unit (ICU) admission or assisted 
ventilation (including both invasive and non-invasive) in the 6 weeks before screening and did not return to 
their previous (pre-COVID-19 infection) respiratory status. 
7. Subject has any of the following serious and/or uncontrolled medical conditions: 
a. 
Chronic obstructive pulmonary disease (COPD). 
b. Idiopathic pulmonary fibrosis (IPF). 
c. 
Subjects with uncontrolled diabetes (eg, hemoglobin A1c [HbA1c] ≥ 9%). 

Sponsor Name: RAPT Therapeutics, Inc. 
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d. Stage III or IV cardiac failure according to the New York Heart Association classification. 
e. 
Acute myocardial infarction, clinically significant arrythmia, or indications of serious underlying heart 
disease)/vital signs abnormality that, in the opinion of the Investigator would be indicative of an 
underlying medical condition, puts the subject at undue risk, and/or interfere with interpretation of 
study results. 
f. 
Severe renal conditions (eg, subjects on dialysis). 
g. Active autoimmune disease (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory 
bowel disease). 
h. Subject has a history of a clinically significant systemic infection or serious respiratory infection 
requiring parenteral antibiotic treatment within 4 weeks prior to the Baseline (Day 1) visit, or oral 
therapy within 2 weeks prior to the Baseline (Day 1) visit. 
i. 
Subject has a diagnosis of, is suspected of having, or is at high risk for an endoparasitic infection unless 
clinical and laboratory assessment have ruled out active endoparasitosis prior to the Baseline (Day 1) 
visit. 
j. 
Subjects with moderate-to-severe hepatic impairment (ie, Child-Pugh score ≥ 7). 
k. Subject has a history of a life-threatening asthma exacerbation in the last 5 years including but not 
limited to requirements for intubation and ventilation. 
8. Subject has had a major surgery in the past 8 weeks prior to Screening or has a major, elective surgery 
planned during the study. 
9. Any of the following specific laboratory findings: 
a. 
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal 
(ULN). 
b. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (Modification of Diet in Renal 
Disease (MDRD) equation) unless considered normal for age.  
c. 
Platelet count < 75,000 cells/mm3. 
d. Hemoglobin < 10 g/dL. 
e. 
Absolute lymphocyte count < 800 cells per mm3. 
f. 
Absolute neutrophil count < 1500 cells per mm3. 
Note: Subjects who have abnormal laboratory values listed in this criterion may have repeat assessment 
of abnormalities once during the Screening and/or Run-In periods. 
10. Subject has a history of drug and/or alcohol abuse in the last 12 months prior to Screening. 
11. Subject has any evidence of an ongoing exacerbation of asthma at the Baseline (Day 1) visit. 
12. Requires systemic oral corticosteroids for the treatment of asthma at the Screening visit. 
13. Systemic corticosteroid use (oral or intravenous) in the 4 weeks prior to Screening. 
Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing 
corticosteroids are also allowed. 
14. Hospitalization for a severe asthma exacerbation in the 4 weeks prior to Screening. 
15. Subject has any state of immunodeficiency due to primary or secondary immunodeficiency syndromes, 
organ transplant (except corneal transplant), previous opportunistic infections, or any other state of 
immunodeficiency, as judged by the Investigator. 
16. Subject has received RPT193 in the past. 
17. Subject who is still participating in a clinical trial or who has participated in a clinical trial within 1 month 
prior to the Screening visit. 
18. Subject has received an investigational oral, systemic agent within 8 weeks or 5 half-lives (whichever is 
longer) prior to the Baseline (Day 1) visit. 
19. Subject has received any of the following marketed biological agents within the following timeframes prior 
to the Baseline (Day 1) visit: 
a. 
Omalizumab within 20 weeks. 
b. Mepolizumab within 16 weeks. 
c. 
Benralizumab within 16 weeks. 
d. Reslizumab within 16 weeks. 

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e. 
Dupilumab within 16 weeks. 
f. 
Tezepelumab within 16 weeks. 
g. Intravenous or subcutaneous immunoglobulin G (IgG) within 16 weeks. 
20. Subject has received any investigational (intravenous or subcutaneous) biological agent within 16 weeks or 
5 half-lives, whichever is longer prior to the Baseline (Day 1) visit.   
21. Subject has used a cell-depleting agent, including but not limited to rituximab, within 6 months prior to the 
screening visit, or until lymphocyte counts return to normal, whichever is longer. 
Note: If a subject has received rituximab, the subject’s lymphocyte count must be within the normal range 
at randomization even if rituximab was received more than 6 months prior to the Baseline (Day 1) visit. 
22. Subject has had bronchial thermoplasty within the last 2 years prior to Screening. 
23. Subject has received treatment with systemic immunosuppressive/immunomodulating drugs 
(eg, methotrexate, cyclosporine A, systemic Janus kinase (JAK) inhibitors, mycophenolic acid, or 
azathioprine) within 4 weeks prior to the Baseline (Day 1) visit.  
24. Subject has begun an allergen-specific immunotherapy regimen or had a clinically relevant change to their 
immunotherapy within 4 weeks prior to the Baseline (Day 1) visit. 
25. Subject has received a live or live attenuated vaccine within 4 weeks prior to the Baseline (Day 1) visit or 
plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks after the last IP 
administration. 
26. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to the Baseline (Day 1) 
visit.  
Note: Subjects with the below medical conditions can be considered, as judged by the Investigator if it 
was treated and completely resolved: 
• 
Cutaneous basal cell carcinoma. 
• 
Cutaneous squamous cell carcinoma in situ. 
• 
Cervical cancer in situ. 
• 
Melanoma in situ. 
27. Subject has a known active bacterial, viral, fungal, helminth, or mycobacterial, or any other infection at the 
Baseline (Day 1) visit (non-complicated recurrent muco-cutaneous infections such as cold sores, tinea pedis, 
or disto-lateral mild to moderate onychomycosis are not considered exclusionary). 
Note: Subjects for whom infections have resolved and otherwise meet eligibility criteria may be 
re-screened once. 
28. Subject has had a positive tuberculosis (TB) infection test at Screening. Subject will be evaluated for latent 
TB infection with a QuantiFERON-TB Gold test. Subjects who demonstrate evidence of latent TB infection 
with a positive QuantiFERON-TB Gold test, irrespective of bacille Calmette-Guérin vaccination status, will 
not be allowed to participate in the study, unless the subject has a documented history of chemoprophylaxis 
for latent TB infection or a documented history of treatment for active TB infection along with 
review/approval from the Sponsor.  
29. Subject has a positive screen for hepatitis B surface antigen (HbsAg), hepatitis C (HCV) antibodies, or 
human immunodeficiency virus (HIV) antibodies. For HBsAg or HCV antibody positive screening, subjects 
may be enrolled if reflex testing (eg, HBV-DNA or HCV RNA) is negative and indicative that there is no 
active infection. 
30. e-Diary completion compliance < 80%, or more than 2 consecutive days missing data during the run-in 
period. Less than 80% translates to less than 12 out of 14 days and this calculation can be used to assess 
eligibility of subject’s e-Diary completion compliance during the run-in period. 
Note: If e-Diary compliance is < 80 %, or a subject has more than 2 consecutive days of missing data 
during the first 2 weeks of the run-in, retraining must be organized, and compliance assessed in the 
following 2 weeks. If during this second period compliance is ≥ 80% and there are no missing data for 
2 or more consecutive days, the subject may be considered eligible related to this criterion. 
31. Subject is an employee or is known to be a relative of an employee of the study center or RAPT. 
Investigational Product: 
Name: RPT193 

Sponsor Name: RAPT Therapeutics, Inc. 
Protocol Number: RPT193-03 
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STUDY SCHEMATIC 
         Figure 1: 
Study Schematic 
 
Abbreviations: ICS = inhaled corticosteroids; LABA = long-acting beta 2 agonist; SABA = short-acting beta 2 agonist.  

Sponsor Name: RAPT Therapeutics, Inc. 
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TABLE OF CONTENTS 
  
CLINICAL STUDY PROTOCOL ...................................................................................1 
PROTOCOL SIGNATURE PAGE – SPONSOR ...........................................................2 
PROTOCOL SIGNATURE PAGE – COORDINATING INVESTIGATOR .............3 
PROTOCOL SIGNATURE PAGE – INVESTIGATOR ...............................................4 
SERIOUS ADVERSE EVENT (SAE) AND ADVERSE EVENT OF CLINICAL 
INTEREST (AECI) CONTACT INFORMATION .................................................5 
PROTOCOL SYNOPSIS ..................................................................................................6 
STUDY SCHEMATIC ....................................................................................................13 
SCHEDULE OF ASSESSMENTS .................................................................................14 
TABLE OF CONTENTS ................................................................................................19 
LIST OF FIGURES .........................................................................................................22 
LIST OF ABBREVIATIONS .........................................................................................23 
1 
INTRODUCTION AND RATIONALE .................................................................26 
1.1 
Background ............................................................................................................26 
1.2 
Nonclinical Studies ................................................................................................27 
1.3 
Clinical Studies ......................................................................................................27 
1.4 
Study Rationale ......................................................................................................28 
1.5 
Dose Justification ...................................................................................................28 
1.6 
Benefit/Risk Assessment .......................................................................................29 
2 
STUDY OBJECTIVES AND ENDPOINTS ..........................................................30 
3 
STUDY PLAN ...........................................................................................................32 
3.1 
Overall Study Design and Plan ..............................................................................32 
3.2 
Discussion of Study Design ...................................................................................33 
3.3 
End of Study ..........................................................................................................34 
3.4 
Study Committees ..................................................................................................34 
3.5 
Safety Monitoring Plan ..........................................................................................34 
4 
STUDY POPULATION ...........................................................................................35 
4.1 
Inclusion Criteria ...................................................................................................35 
4.2 
Exclusion Criteria ..................................................................................................38 
4.3 
Screen Failures .......................................................................................................43 
4.4 
Discontinuation of Investigational Product and Subject Withdrawal from the 
Study ......................................................................................................................44 
4.4.1 
Discontinuation of Investigational Product .....................................................44 
4.4.2 
Subject Withdrawal from the Study .................................................................46 
4.4.3 
Laboratory Abnormalities Requiring Discontinuation of Study Intervention .47 
4.4.4 
Possible Case of Drug-Induced Liver Injury ...................................................47 
4.4.5 
Lost to Follow-up .............................................................................................48 
5 
DESCRIPTION OF STUDY ASSESSMENTS ......................................................49 
5.1 
Demographics and Other Screening Assessments .................................................49 
5.1.1 
Medical History ...............................................................................................49 
5.1.2 
Demography .....................................................................................................49 
5.1.3 
Tuberculosis Test .............................................................................................49 
5.2 
Efficacy Assessments.............................................................................................50 
5.2.1 
Loss of Asthma Control ...................................................................................50 
5.2.2 
Fractional Exhaled Nitric Oxide ......................................................................51 

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Abbreviation 
Definition 
GINA 
Global Initiative for Asthma 
GLP 
Good Laboratory Practice 
HbA1c 
hemoglobin A1c 
HbsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
hERG 
human ether à go go gene 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
IB 
Investigator’s Brochure 
IBD 
inflammatory bowel disease 
IC50 
50% inhibitory concentration 
IC90 
90% inhibitory concentration 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
ICS 
inhaled corticosteroids 
ICU 
intensive care unit 
IEC 
Independent Ethics Committee 
Ig 
immunoglobulin 
IL 
interleukin 
INR 
international normalized ratio 
IP 
investigational product 
IPF 
idiopathic pulmonary fibrosis 
IRB 
Institutional Review Board 
ITT 
intention to treat 
IXRS 
interactive voice response system/interactive web response system 
JAK 
Janus kinase 
K-M 
Kaplan-Meier 
LABA 
long-acting beta 2 agonist 
LAMA 
long-acting muscarinic agonist 
LOAC 
loss of asthma control 
LTRA 
leukotriene receptor antagonist 
MACE 
major adverse cardiac event 
MDI 
metered dose inhaler 
MDRD 
Modified Diet in Renal Disease 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed model repeated measures 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
PD 
pharmacodynamic(s) 

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1 INTRODUCTION AND RATIONALE 
1.1 
Background 
Th2 cells express high levels of C-C motif chemokine receptor 4 (CCR4) and are clinically 
important drivers of allergic diseases which include atopic dermatitis, food allergy, asthma, and 
allergic conjunctivitis/rhinosinusitis as well as additional diseases such as chronic urticaria and 
eosinophilic esophagitis (Vestergaard 2003). Th2 cells trigger immune responses when a 
pathogen comes into contact with the skin or mucosal lining of the nose or lungs. It is believed 
that innate immune cells and antibodies that recognize the pathogen initiate a release of 
inflammatory cytokines, leading to the recruitment of other immune system components, 
including Th2 cells. Th2 cells secrete proinflammatory cytokines, such as interleukin (IL)-4, 
IL-5, and IL-13 (Koyasu 2011). Collectively, these cytokines and resultant biology have been 
coined “type 2 cytokines”. While this type 2 cytokine response may be highly effective against 
foreign pathogens, particularly parasites, sometimes the body overreacts to benign substances in 
this way, resulting in a significant influx of Th2 cells, leading to a number of conditions 
(Bosnjak 2011; Kubo 2017). 
At a cellular and molecular level, the Th2 response is initiated and sustained when Th2 cells are 
recruited to the site of inflammation by binding of C-C motif chemokine ligand (CCL)17 and 
CCL22 to CCR4 (Viney 2014). Subjects suffering from atopic dermatitis, asthma, and other 
allergic disorders have significantly elevated levels of both CCL17 and CCL22 (Hartl 2009; 
Kataoka 2014), suggesting that inhibiting the ability of these chemokines to bind to CCR4 may 
prevent migration of Th2 cells into these inflamed sites.  
RPT193 is an orally (PO) bioavailable, highly selective small molecule CCR4 antagonist that 
blocks the recruitment of inflammatory immune cells, known as Th2 cells, which are clinically 
implicated in allergic inflammatory disorders (Vestergaard 2003). RPT193 is a first-in-class 
CCR4 antagonist being developed for allergic inflammatory diseases. Preclinical pharmacology 
and toxicology results suggested (i) efficacy similar to clinically validated mechanisms in 
allergic inflammatory disease models, (ii) once daily PO dosing may be sufficient, and (iii) a 
safety profile compatible with chronic dosing in humans.  
RPT193 has demonstrated efficacy in multiple preclinical mouse models of atopic dermatitis and 
asthma. The observed efficacy was comparable to that of a commercially available anti-mouse 
IL-13 antibody, which represents the class of biologics such as dupilumab, lebrikizumab, and 
others targeting Th2-derived cytokines such as IL-4, IL-5, and IL-13. The results observed in 
these models demonstrate the clinical potential to treat a number of Th2-driven disorders in 
humans. 
As a monotherapy in subjects with moderate-to-severe atopic dermatitis, RPT193 demonstrated 
evidence of clinical effect with improvements over placebo in Eczema Area and Severity Index 
(EASI), Scoring of Atopic Dermatitis (SCORAD), extent of body surface area (BSA) affected by 
atopic dermatitis, validated Investigator Global Assessment (vIGA) and patient-reported 
outcomes (eg, daily peak pruritus numerical rating scale as well as sleep and pruritus 
assessments within the SCORAD instrument) after 28 days of dosing. Further improvements in 
EASI, SCORAD, BSA, and vIGA were observed at Day 43, 2 weeks after the cessation of 
dosing. Overall, the results of the Phase 1 trial in subjects with moderate-to-severe atopic 

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• 
To evaluate the PK of RPT193 following 
administration of 400 mg of RPT193 
administered orally once daily for 14 weeks 
to subjects with asthma 
• 
PK parameters at Days 29, 43, 71, 99, and 113 (Weeks 4, 
6, 10, 14, and 16) 
• 
To evaluate the effect of RPT193 treatment 
on serum analytes, transcription in 
peripheral blood and peripheral immune 
populations and biomarkers associated with 
asthma 
• 
Change in serum cytokines, chemokines, and other 
soluble analytes 
• 
Change in transcription in peripheral blood 
• 
Change in peripheral immune populations 
• 
To evaluate the effects of RPT193 on nasal 
biomarkers 
• 
Changes in the nasal transcriptome and nasal proteome 
 

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3 STUDY PLAN 
3.1 
Overall Study Design and Plan 
This is a Phase 2, randomized, multicenter, double-blind, POC study with RPT193 in subjects 
with moderate-to-severe T2-high asthma who are partially controlled on medium or high doses 
of ICS and long-acting beta agonists (LABA). Approximately 100 subjects will be enrolled 1:1 
into 1 of 2 arms (RPT193 versus matched placebo). 
Male or female adults aged 18 to 75 years will be included in this study. The study design is 
outlined in Figure 1, and the visit schedule and planned assessments at each visit are detailed 
inTable 1. 
The Investigator will obtain signed informed consent from the subject before any study 
procedures are performed. For further details regarding the informed consent process, see 
Section 10.3.  
After an initial screening period of up to 14 days, subjects will enter a run-in period of 28 days to 
standardize background inhaled ICS and LABA (Period 1). The standardized background 
ICS/LABA regimen must be commensurate to the subject’s ICS/LABA dose at the 
Screening visit as described in Appendix V – Section 17.5. If a subject is considered eligible at 
the Baseline (Day 1) visit, each subject (n~100) will be randomized (1:1) to receive RPT193 or 
placebo as oral tablets daily from Baseline (Day 1) to Day 98. Enrolled subjects will receive 
RPT193 or matching placebo for 14 weeks with management of background ICS and LABA 
during the following Periods:  
• Period 2) from Baseline (Day 1) through Day 42, subjects will receive RPT193 as adjunctive 
therapy to background ICS and LABA,  
• Period 3) from Day 43 (Week 6) to Day 56, subjects will have LABA withdrawn and remain 
on medium- or high-dose ICS,  
• Period 4) starting at Day 57 (Week 8), subjects will undergo a 2- to 3-week taper of ICS, and  
• Period 5) starting at Day 78 (Week 11) (or Day 71 [Week 10] for those on medium-dose ICS 
and LABA at baseline), subjects will have a 3- (or 4-) week period of monotherapy. 
Throughout the treatment period, subjects will be followed for evidence of a LOAC event. If a 
subject has a LOAC event, the subject will be immediately discontinued from investigational 
product (IP), returned to their individual, pre-screening inhaled therapy, and remain in the study 
for safety follow-up and further clinical management if necessary. 
Subjects will be administered RPT193 or a matching placebo during the treatment period. Both 
RPT193 and the matching placebo will be given orally. See Section 6.4 for further details on the 
method of assigning subjects to the treatment groups. See Section 6.6 for further details on the 
dose and administration of RPT193 and the matching placebo. 

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The study is randomized and double-blinded with regard to RPT193 and placebo in order to 
prevent bias in treatment allocation and in the assessment of treatment effect. The Investigator, 
site personnel, the Sponsor representatives involved in monitoring and conducting the study, and 
the subjects will be blinded to the IP administered. See Section 6.3 for details on access to the 
treatment codes in the event of emergency unblinding. 
A safety monitoring plan includes real-time monitoring of subjects, using the daily e-Diary as 
well as the internet-enabled PEF meter, for evidence indicative of LOAC so that subjects may be 
quickly evaluated, discontinued from IP, and managed clinically. Per protocol, though such 
subjects will stop IP, they will continue in the trial for clinical follow-up. In addition, a 
Data Monitoring Committee (DMC) comprised of, at a minimum, 2 independent pulmonary 
physicians and 1 biostatistician will evaluate unblinded data at regular timepoints that will be 
outlined in the DMC charter; in addition, the charter will require ad hoc meetings as appropriate 
for potential emerging safety problems, or when important new information external to the trial 
arises. 
3.2 
Discussion of Study Design 
As clinical development of systemic therapeutics in adults with moderate-to-severe asthma has 
moved toward requiring demonstration of an investigational therapeutic’s capacity to decrease 
subjects’ risk for severe exacerbations after 26 to 52 weeks of add-on therapy, designing efficient 
and informative POC studies has become more challenging. POC studies assessing lung function 
and FEV1 as a primary endpoint after add-on therapy with a novel therapeutic have been 
employed for many years. However, recent studies with novel, systemic agents suggest that 
improving FEV1 may not strongly correlate with a therapeutic’s magnitude of effect on 
exacerbations (Zhudenkov 2021; Fielding 2019). Thus, alternative POC study designs may yield 
more information related to the potential of a novel therapy in asthma.  
More recently, placebo-controlled withdrawal designs consisting of a period of add-on therapy 
followed by a period of prescribed tapering of background, inhaled therapies with assessment of 
a “loss of asthma control” as a primary endpoint have emerged as an efficient and informative 
means to assess a therapeutic’s potential to limit asthma exacerbations (Wechsler 2021; 
Wenzel 2013). Thus far, at least 6 studies, from 2011 and continuing through the present, have 
utilized this design as POC for a variety of investigational therapies evaluated in Phase 2 studies, 
including dupilumab (NCT01312961, US only), AZD1419 (NCT02898662, EudraCT 2016-
000977-19, GSK3772847 (NCT03207243; EudraCT 2017-001072-34), itepekimab 
(NCT03387852; EudraCT 2017-003289-29), TEV-48574 (NCT04545385; EudraCT 2020-
001927-15), and rilzabrutinib (NCT05104892; EudraCT 2021-002490-26). Dupilumab has now 
been approved for patients with moderate-to-severe eosinophilic asthma as well as patients with 
asthma requiring chronic oral corticosteroids. Similarly, this study will investigate whether 
RPT193 is capable of preventing LOAC in subjects with partially controlled, 
moderate--to--severe T2 asthma. The current study will be a Phase 2, randomized, double-blind, 
POC study with RPT193 in subjects with moderate-to-severe asthma who are partially controlled 
on medium or high doses of ICS and LABA. Subjects who fulfill all the inclusion criteria and 
meet none of the exclusion criteria will be accepted into the study. After a screening/run-in 
period of no more than 42 days, subjects (n~100) will be randomized (1:1) on Baseline (Day 1) 
to receive RPT193 or placebo as oral tablet(s) daily from Baseline (Day 1) to Day 98.  

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3.3 
End of Study 
A subject is considered to have completed the study if s/he has completed all study visits. 
The end of the study is defined as the date of the last visit or last procedure of the last subject in 
the study. 
3.4 
Study Committees  
A DMC will review unblinded safety and efficacy data and has a primary responsibility of 
providing the Sponsor with recommendations regarding the conduct of the study. The DMC is 
comprised of individuals with expertise in asthma from a medical and biostatistical perspective. 
The DMC members are external to the Sponsor and the conduct of the study. The DMC 
procedures and data to be reviewed are described in the DMC charter. The DMC will evaluate 
unblinded data at regular timepoints that are outlined in the DMC charter; in addition, the charter 
requires ad hoc meetings as appropriate for potential emerging safety problems, or when 
important new information external to the trial arises. 
3.5 
Safety Monitoring Plan 
Real-time monitoring of subjects for evidence indicative of LOAC is being implemented in this 
study so that subjects may be quickly evaluated and managed accordingly. Further details are 
found in the Safety Monitoring Plan and include the use of real-time alerts for evidence of 
LOAC and/or missing data. In addition, subjects are required to return to the study site weekly 
during the period of withdrawal of ICS therapy. 
Per protocol, subjects who demonstrate evidence of LOAC will be returned to their individual, 
pre-screening inhaled therapy and managed for escalation of therapy as appropriate and 
determined by the Principal Investigator (PI) at the site. While subjects will be discontinued from 
study IP, subjects will continue in the trial for clinical follow-up (see Section 5.2.1). 

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12. 
Female subject agrees to not have egg retrieval during the study and for 30 days after the 
last IP administration. 
13. 
For male subject involved in any sexual intercourse that could lead to pregnancy, subject 
must agree to use 1 of the highly effective contraceptive methods listed in Inclusion 
Criterion #11 from Baseline (Day 1) until at least 90 days after the last IP administration. If 
the female partner of a male subject uses any of the hormonal contraceptive methods listed 
above, this contraceptive method should be used by the female partner from at least 4 
weeks before Baseline (Day 1) until at least 90 days after the last IP administration. 
14. 
Male subject agrees not to donate sperm during the study and for 90 days after the last IP 
administration. 
15. 
Subject is willing to participate and is capable of giving informed consent. 
Note: Consent must be obtained prior to any study-related procedures. 

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4.2 
Exclusion Criteria 
A subject who meets any of the following exclusion criteria will not be eligible for inclusion in 
the study: 
1. 
Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant 
during the study. 
2. 
History of smoking per age group as follows (see also Exclusion Criterion #3): 
a. < 30 years old: Smoked for ≥ 5 pack-years.* 
b. 30 to 39 years old (inclusive): Smoked for ≥ 10 pack-years. 
c. ≥ 40 years old: Smoked for ≥ 15 pack-years. 
*One pack-year of cigarettes is defined as 1 pack of cigarettes a day for 1 year and is 
equivalent to: 
• 1 cigar or pipe per day for 1 year. 
• 1 hookah or shisha smoking session per day for 1 year. 
• 0.5 mL e-liquid per day for 1 year or 1 cartridge/tank/pod per day for 1 year of 
vaped e-cigarettes. 
• 1 use of smoked marijuana per day for 1 year. 
3. 
Active use of any inhalant >1 time weekly in the past year including: 
a. Active smoking of conventional tobacco, marijuana (in any inhaled form) or other 
drugs, or vaping of e-cigarettes or e-devices. 
b. Other forms of tobacco including: 1 cigarette, 1 hookah or shisha session, 1 cigar, or 
1 pipe. 
Note: Subjects must agree to refrain from using any inhalant as noted above more than 
1 time weekly from the time they provide written informed consent until they complete 
all safety follow-up visits (ie, Day 141 / Week 20). 
4. 
Subject has any serious and/or uncontrolled medical condition (including cognitive 
impairment, alcohol/drug abuse, or signs/symptoms suspicious for a serious disease) or 
laboratory abnormality that would place subject’s safety at risk or interfere with study 
participation, as judged by the Investigator. 
5. 
Conditions that may mimic asthma (eg, vocal cord dysfunction, hyperventilation, panic 
attacks, cardiac asthma, uncontrolled gastroesophageal reflux disease). 

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6. 
Subject has a history of severe COVID-19 that required intensive care unit (ICU) 
admission or assisted ventilation (including both invasive and non-invasive) in the 6 weeks 
before screening and did not return to their previous (pre-COVID-19 infection) respiratory 
status. 
7. 
Subject has any of the following serious and/or uncontrolled medical conditions: 
a. Chronic obstructive pulmonary disease (COPD). 
b. Idiopathic pulmonary fibrosis (IPF). 
c. Subjects with uncontrolled diabetes (eg, hemoglobin A1c [HbA1c] ≥ 9%). 
d. Stage III or IV cardiac failure according to the New York Heart Association 
classification. 
e. Acute myocardial infarction, clinically significant arrythmia, or indications of serious 
underlying heart disease)/vital signs abnormality that, in the opinion of the Investigator 
would be indicative of an underlying medical condition, puts the subject at undue risk, 
and/or interfere with interpretation of study results. 
f. Severe renal conditions (eg, subjects on dialysis). 
g. Active autoimmune disease (eg, systemic lupus erythematosus, rheumatoid arthritis, 
inflammatory bowel disease). 
h. Subject has a history of a clinically significant systemic infection or serious respiratory 
infection requiring parenteral antibiotic treatment within 4 weeks prior to the Baseline 
(Day 1) visit, or oral therapy within 2 weeks prior to the Baseline (Day 1) visit. 
i. Subject has a diagnosis of, is suspected of having, or is at high risk for an endoparasitic 
infection unless clinical and laboratory assessment have ruled out active 
endoparasitosis prior to the Baseline (Day 1) visit. 
j. Subjects with moderate to severe hepatic impairment (ie, Child-Pugh score ≥ 7). 
k. Subject has a history of a life-threatening asthma exacerbation in the last 5 years 
including but not limited to requirements for intubation and ventilation. 
8. 
Subject has had a major surgery in the past 8 weeks prior to Screening or has a major, 
elective surgery planned during the study. 
9. 
Any of the following specific laboratory findings: 
a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper 
limit of normal (ULN). 
b. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (Modification of Diet 
in Renal Disease [MDRD] equation) unless considered normal for age. 

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c. Platelet count < 75,000 cells/mm3. 
d. Hemoglobin < 10 g/dL. 
e. Absolute lymphocyte count < 800 cells per mm3. 
f. Absolute neutrophil count < 1500 cells per mm3. 
Note: Subjects who have abnormal laboratory values listed in this criterion may have 
repeat assessment of abnormalities once during the Screening and/or Run-In periods. 
10. 
Subject has a history of drug and/or alcohol abuse in the last 12 months prior to Screening. 
11. 
Subject has any evidence of exacerbation of asthma at the Baseline (Day 1) visit. 
12. 
Requires systemic oral corticosteroids for the treatment of asthma at the Screening visit. 
13. 
Systemic corticosteroid use (oral or intravenous) in the 4 weeks prior to Screening. 
Note: Intranasal corticosteroids and ICS are allowed. Eye and ear drops containing 
corticosteroids are also allowed. 
14. 
Hospitalization for a severe asthma exacerbation in the 4 weeks prior to Screening. 
15. 
Subject has any state of immunodeficiency due to primary or secondary immunodeficiency 
syndromes, organ transplant (except corneal transplant), previous opportunistic infections, 
or any other state of immunodeficiency, as judged by the Investigator. 
16. 
Subject has received RPT193 in the past. 
17. 
Subject who is still participating in a clinical trial or who has participated in a clinical trial 
within 1 month prior to the Screening visit. 
18. 
Subject has received an investigational oral, systemic agent within 8 weeks or 5 half-lives 
(whichever is longer) prior to the Baseline (Day 1) visit. 
19. 
Subject has received any of the following marketed biological agents within the following 
timeframes prior to the Baseline (Day 1) visit: 
a. Omalizumab within 20 weeks. 
b. Mepolizumab within 16 weeks. 
c. Benralizumab within 16 weeks. 
d. Reslizumab within 16 weeks. 
e. Dupilumab within 16 weeks. 

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f. Tezepelumab within 16 weeks. 
g. Intravenous or subcutaneous immunoglobulin G (IgG) within 16 weeks.   
20. 
Subject has received any investigational (intravenous or subcutaneous) biological agent 
within 16 weeks or 5 half-lives, whichever is longer prior to the Baseline (Day 1) visit.   
21. 
Subject has used a cell-depleting agent, including but not limited to rituximab, within 
6 months prior to the screening visit, or until lymphocyte counts return to normal, 
whichever is longer. 
Note: If a subject has received rituximab, the subject’s lymphocyte count must be within 
the normal range at randomization even if rituximab was received more than 6 months 
prior to the Baseline (Day 1) visit. 
22. 
Subject had bronchial thermoplasty within the last 2 years prior to Screening. 
23. 
Subject has received treatment with systemic immunosuppressive/immunomodulating 
drugs (eg, methotrexate, cyclosporine A, systemic Janus kinase (JAK) inhibitors, 
mycophenolic acid, or azathioprine) within 4 weeks prior to the Baseline (Day 1) visit.  
24. 
Subject has begun an allergen-specific immunotherapy regimen or had a clinically relevant 
change to their immunotherapy within 4 weeks prior to the Baseline (Day 1) visit. 
25. 
Subject has received a live or live attenuated vaccine within 4 weeks prior to the Baseline 
(Day 1) visit or plans to receive a live or live-attenuated vaccine during the study and up to 
4 weeks after the last IP administration. 
26. 
Subject has a history of cancer or lymphoproliferative disease within 5 years prior to the 
Baseline (Day 1) visit.  
Note: Subjects with the below medical conditions can be considered, as judged by the 
Investigator if it was treated and completely resolved: 
• Cutaneous basal cell carcinoma. 
• Cutaneous squamous cell carcinoma in situ  
• Cervical cancer in situ. 
• Melanoma in situ. 

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27. 
Subject has a known active bacterial, viral, fungal, helminth, or mycobacterial, or any other 
infection at the Baseline (Day 1) visit (non-complicated recurrent muco-cutaneous 
infections such as cold sores, tinea pedis, or disto-lateral mild to moderate onychomycosis 
are not considered exclusionary). 
Note: Subjects for whom infections have resolved and otherwise meet eligibility criteria 
may be re-screened once. 
28. 
Subject has had a positive tuberculosis (TB) infection test at Screening. Subject will be 
evaluated for latent TB infection with a QuantiFERON-TB Gold test. Subjects who 
demonstrate evidence of latent TB infection with a positive QuantiFERON-TB Gold test, 
irrespective of bacille Calmette-Guérin vaccination status, will not be allowed to participate 
in the study, unless the subject has a documented history of chemoprophylaxis for latent 
TB infection or a documented history of treatment for active TB infection along with 
review/approval from the Sponsor. 
29. 
Subject has a positive screen for hepatitis B surface antigen (HbsAg), hepatitis C (HCV) 
antibodies, or human immunodeficiency virus (HIV) antibodies. For HBsAg or HCV 
antibody positive screening, subjects may be enrolled if reflex testing (eg, HBV-DNA or 
HCV RNA) is negative and indicative that there is no active infection. 
30. 
e-Diary completion compliance < 80%, or more than 2 consecutive days missing data 
during the run-in period. Less than 80% translates to less than 12 out of 14 days and this 
calculation can be used to assess eligibility of subject’s e-Diary completion compliance 
during the run-in period. 
Note: If e-Diary compliance is < 80 %, or a subject has more than 2 consecutive days of 
missing data during the first 2 weeks of the run-in, retraining must be organized, and 
compliance assessed in the following 2 weeks. If during this second period compliance is 
≥ 80% and there are no missing data for 2 or more consecutive days, the subject may be 
considered eligible related to this criterion. 
31. 
Subject is an employee or is known to be a relative of an employee of the study center or 
  
 

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5. The subject develops evidence of hepatocellular injury that may be caused by the IP 
consistent with Hy’s Law. Such an AE should be reported as a SAE. For the Hy’s law criteria 
and procedures for evaluating a potential Hy’s law case, see Section 4.4.4. 
6. If a subject exhibits clinical symptoms during the study that may indicate COVID-19 
infection, the subject will be tested for active COVID-19 infection. If the subject tests 
positive and exhibits evidence of moderate or severe illness (based on National Institutes of 
Health (NIH) criteria as depicted in Appendix VI), s/he will be discontinued from IP and will 
attend an EOT visit. Remote assessment of safety via teleconference and/or videoconference, 
with videoconference being the preferred method, is recommended until the subject attends 
the early termination (ET) visit.   
7. Onset of an opportunistic infection during the study. 
8. The subject develops any other illness that would interfere with continued treatment in the 
study. 
9. The subject, for any reason, requires treatment with another systemic therapeutic agent that 
has been demonstrated to be effective for treatment of the study indication (eg, oral 
corticosteroids, dupilumab, mepolizumab, reslizumab, benralizumab, or omalizumab). In this 
case, discontinuation from the study IP occurs immediately upon introduction of the new 
agent. 
10. The subject requires treatment with any other prohibited medications as defined in this 
protocol. 
11. The subject is noncompliant with study procedures or medication, in the opinion of the 
Investigator. 
Note: Compliance for the e-Diary is considered when > 80% of data are present as well as a 
lack of repeated instances of missing data for 2 or more days. For study IP, compliance 
would be considered if IP is taken > 80% of the time. 
12. The subject is confirmed to be pregnant. 
13. The Sponsor or regulatory agency requests withdrawal of the subject. 
If IP is prematurely discontinued, subjects should be strongly encouraged to remain in the study 
and complete the End of Treatment and Safety Follow-up Visits (see Table 1). The information 
pertaining to discontinuation of IP and the reasons for it must be recorded in the eCRF. Subjects 
who discontinue IP prematurely will not be replaced.  

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4.4.3 
Laboratory Abnormalities Requiring Discontinuation of Study Intervention 
Table 2:  Severe Laboratory Abnormalities Requiring Permanent Discontinuation of IP 
Laboratory Parameter 
Abnormality 
Absolute neutrophil count (ANC) 
< 500 cells per mm3 
Absolute lymphocyte count (ALC) 
< 200 cells per mm3 
Hemoglobin 
< 6.5 mg/dL 
Platelet count 
< 50,000 per mm3 
Creatinine 
> 3 × baseline value or  
> 3 × ULN 
Alanine aminotransferase (ALT) 
If abnormal baseline value, > 5 × baseline value for more than 
2 weeks; If normal baseline value, > 5 × ULN for more than 2 weeks 
Subjects should first have laboratory abnormalities verified by repeat measure, and if repeat 
measure confirms the new onset abnormality, such subjects should be discontinued from further 
IP dosing, and if applicable, followed for resolution(see Section 4.4.1). 
4.4.4 
Possible Case of Drug-Induced Liver Injury  
Subjects who present with evidence of hepatocellular injury that may be caused by drug 
ingestion consistent with Hy’s Law with all of the following criteria acutely should be 
re-evaluated: 
• ALT or AST > 3 × ULN 
• Total bilirubin > 2× ULN 
• No signs of cholestasis (alkaline phosphatase [ALP] < 2 × ULN) 
• No other assignable cause such as liver metastases, pre-existing hepatic disease, viral 
hepatitis, alcohol abuse, ischemia, etc. 
Re-evaluation should include repeat of AST, ALT, total bilirubin, and alkaline phosphatase 
along with additional laboratory assessments including albumin, creatine kinase, direct bilirubin, 
gamma-glutamyl transferase (GGT), and prothrombin time (PT)/international normalized ratio 
(INR). Additional medical and/or laboratory investigation to investigate other potential causes 
(eg, alcohol use, infectious hepatitis) should also be considered and assessed as appropriate by 
the Investigator. Potential cases satisfying Hy’s law should be reported as SAEs. If a subject 
satisfies Hy’s law, IP should be discontinued for the subject (see Section 4.4.1). 

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4.4.5 
Lost to Follow-up 
Subjects will be considered lost to follow-up if they repeatedly fail to return for scheduled visits 
and are unable to be contacted by the study site staff. 
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. 
• Before a 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 or study file of 
the subject.  
• Should the subject continue to be unreachable, s/he will be considered to have withdrawn 
from the study. 

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5.2 
Efficacy Assessments 
5.2.1 
Loss of Asthma Control  
LOAC will be measured as follows: 
• ≥ 30% reduction in morning PEF from Baseline on 2 consecutive days, 
• ≥ 6 additional reliever inhalations of SABA in a 24-hour period relative to baseline on 
2 consecutive days, 
• Increase by a factor of 4 or more in the most recent dose of ICS (or if ICS has been fully 
withdrawn, ≥ 50% of the prescribed ICS dose at baseline) 
• Exacerbation requiring systemic corticosteroids. 
• Exacerbation of asthma-related adverse events that requires a hospitalization or emergency 
room visit. 
If a subject satisfies criteria for a LOAC event during any point after randomization, the subject 
will be discontinued from study IP and undergo an End of Treatment visit. Subjects will return to 
their individual pre-screening inhaled therapy once a LOAC event has occurred. Escalation of 
therapy may also be considered at PI discretion. While subjects will discontinue study IP upon a 
LOAC event, subjects will continue in the study with safety follow-up for further clinical 
monitoring and adjustment of therapy as needed per Investigator discretion. 
5.2.1.1 
Peak Expiratory Flow 
The efficacy of 400 mg RPT193 on reducing LOAC events when administered orally once daily 
for 14 weeks to subjects with asthma will in part be measured by determining the number of 
subjects who have a ≥ 30% reduction in morning PEF from baseline on 2 consecutive days.  
• Morning PEF should be performed within 15 minutes after arising (between 5 AM upon 
arising in the morning and 12 PM). 
• Evening PEF should be performed between 5 PM And 11:59 PM. 
• Three PEF efforts will be performed by the subject with all 3 values recorded on the device 
and the highest value used for evaluation. 
During the Screening and run-in period, PEF data will be checked for compliance and 
correctness of performing the procedure in order to obtain consistent values. During 
Periods 2 through 5, PEF will be assessed for a drop in values and triggering subject contact if it 
falls below the threshold, which is ≥ 30% reduction from the Baseline value. The Baseline value 
will be considered as the mean AM measurement assessed for all available PEF measurements in 
the 7 days prior to the Day 1 visit. Per eligibility criteria, subjects must have at least 
5 measurements during the 7 days prior to randomization. 

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5.2.1.2 
e-Diary 
5.2.1.2.1 
Asthma Reliever Medication Use 
Subjects will record if they have taken 6 or more distinct inhalations/puffs of SABA/quick-relief 
inhaler in the e-diary daily. 
Note: SABA therapy used for exercise pretreatment or for reversibility testing should not be 
considered as being used for asthma relief and should not count toward the number of puffs to be 
recorded in the e-Diary. Study sites should monitor reliever medication use during the study 
visits at the time points indicated in Table 1. 
5.2.1.2.2 
Inhaled Corticosteroid Use 
Subjects will record whether they have used ICS in the e-Diary daily and the number of puffs 
used daily. This is to be verified/confirmed by Investigator or study staff during site visits. 
5.2.1.2.3 
Systemic Corticosteroid Use 
Subjects will record whether they have used systemic corticosteroid in the e-Diary daily and this 
is to be verified/confirmed by Investigator or study staff during site visits.  
5.2.1.2.4 
Emergency Room Visits Due to Asthma and Hospitalization Due to 
Asthma  
Subjects will record whether they have had any emergency room (ER) visits and/or 
hospitalizations in the e-Diary daily and this is to be verified/confirmed by Investigator or study 
staff during site visits. 
5.2.2 
Fractional Exhaled Nitric Oxide  
The change in FeNO at Day 99 (Week 14) and at each interval visit after treatment with RPT193 
compared to baseline will be determined. Additionally, the change in FeNO from Day 99 to 140 
(Weeks 14 to 20) will also be determined. 
FeNO should be performed prior to spirometry and following a fast of at least 1 hour. 
5.2.3 
Spirometry 
Pulmonary function testing will be performed using a spirometer. On-site spirometry will include 
full-flow volume loops (forced vital capacity [FVC], FEV1, FEV1/FVC, forced mid-expiratory 
flow [FEF25%-75%], and PEF) and should be done according to American Thoracic 
Society/European Respiratory Society procedural guidelines (Graham 2019), verified, and 
overread centrally. Measurements will be done according to methods described separately in the 
Spirometry Manual. A central spirometry reading facility will be used to provide standardized 
training on spirometry, qualification of the spirometry technician, and quality control of the 
spirometry throughout the study. 

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5.3.2 
Clinical Laboratory Evaluations 
Laboratory assessments will be performed by a central laboratory. Blood and urine samples will 
be collected at the times indicated in Table 1. Subjects will be required to be fasting at Baseline 
(Day 1), Day 99 (Week 14), and Day 113 (Week 16). For fasting labs, a subject should refrain 
from eating or drinking (except for water) for a period of at least 8 hours prior to the laboratory 
draw. On dosing day(s) sampling for the analysis of clinical laboratory parameters will be 
performed before the administration of IP. 
The parameters to be evaluated are shown in Table 3. 
Table 3:  
Clinical Laboratory Evaluations 
Clinical Chemistry Panel 
Albumin 
Alkaline phosphatase 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Chloride 
Cholesterol 
HDL cholesterol 
LDL cholesterol 
Creatinine, enzymatic 
Direct bilirubin 
Total bilirubin 
Potassium 
Glucose 
Sodium 
Gamma-glutamyl transferase 
Triglycerides 
Urea 
Uric Acid 
Calcium 
Total protein 
Lactate dehydrogenase (LDH) 
Bicarbonate 
Magnesium 
Phosphorus  
Hematology 
Red blood cells 
Hemoglobin 
Hematocrit 
MPV, MCV, MCH, MCHC 
Platelets 
White blood cells (WBC) 
WBC Differential (% and 
absolute) 
• 
Neutrophils 
• 
Eosinophils 
• 
Basophils 
• 
Lymphocytes 
• 
Monocytes  
 
Urinalysis 
Bilirubin 
Blood 
Glucose 
Ketones 
Nitrite 
pH 
Protein 
Microscopic examination1 
Urobilinogen 
Leukocytes 
Specific gravity 
Coagulation Panel 
aPTT (sec) 
PT (sec) 
INR 
 
Women Only Testing 
Serum βhCG 
Urine hCG 
FSH (women of non-childbearing 
potential only) 
Estradiol (women of 
non-childbearing potential only) 
 
Screening Tests 
Hepatitis B surface antigen 
Hepatitis B surface antibody 
Hepatitis B core antibody 
Hepatitis C antibody 
HIV-1/2 antibody & antigen 
QuantiFERON TB Gold TB Screen 
 
Other Tests 
Reticulocytes 
eGFR 
Hemoglobin A1C 
 
Abbreviations: aPTT = activated partial prothrombin time; βhCG = β-subunit of human chorionic gonadotropin 
(pregnancy test); eGFR = estimated glomerular filtration rate; hCG = human chorionic gonadotropin; HIV = human 
immunodeficiency virus; INR = international normalized ratio; MCH = mean corpuscular hemoglobin; 
MCHC = mean corpuscular hemoglobin concentration; MCV = mean corpuscular volume; MPV = mean platelet 
volume; PT = prothrombin time.  
1. Will be performed on abnormal findings unless otherwise specified. 
Refer to the Laboratory Manual for details regarding the collection, processing, and shipping of 
the blood and urine samples. 
The Investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the eCRF. The 
laboratory reports must be filed with the source documents. Clinically significant abnormal 

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laboratory findings are those that are not associated with the underlying disease, unless judged 
by the Investigator to be more severe than expected for the subject’s condition. 
All laboratory tests with values considered clinically significantly abnormal during the subject’s 
participation in the study or within 42 days after the last dose of IP 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 such values do not return to normal/baseline within a period of time judged reasonable by the 
Investigator, then the etiology should be identified, and the Sponsor notified. 
5.3.3 
Loss of Asthma Control 
Refer to Section 5.2.1 for further guidance related to LOAC events. 
5.3.4 
12-lead Electrocardiogram 
Twelve-lead ECGs will be obtained as outlined in Table 1 using an ECG machine that 
automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. 
The ECG tracing should include the date and time of the assessment and the signature of the 
person who made the interpretation; the tracing will be archived at the study site. Triplicate ECG 
should be performed prior to spirometry or FeNO measurements to prevent potential effects of 
beta agonist use on ECG measurements. 
5.3.5 
Vital Signs 
Vital signs will be measured in a semi-supine position after 5 minutes’ rest and will include 
temperature, systolic and diastolic blood pressure, pulse, and respiratory rate. 
5.3.6 
Physical Examination 
Subjects will undergo complete physical examination as indicated in the schedule of 
assessments. 
The complete physical examination will include assessments of the standard physical 
examination items, including general appearance, skin, eyes, ears, nose, throat, head and neck, 
heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological, and 
other body systems, if applicable, for describing the status of the subject’s health. 
Body weight and height will also be measured and recorded. The subject should be dressed in 
light clothing, without shoes. Subject height and weight will be recorded at Screening and weight 
will be recorded on Day 141 (Week 20). 
After the initial, complete physical examination, a target physical examination will include, at a 
minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and 
spleen). 

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• 
 
 
 
 
 
5.6.2 
Nasal Sampling for Biomarker Analysis  
Changes in nasal biomarkers will be assessed at the time points indicated in Table 1. 
5.7 
Pharmacogenetics 
A blood sample for DNA isolation will be collected from subjects who have consented to 
participate in the genetic analysis component of the study. Participation is optional. Subjects who 
do not wish to participate in the genetic research may still participate in the study. 
In the event of DNA extraction failure, a replacement genetic blood sample may be requested 
from the subject. Signed informed consent will be required to obtain a replacement sample 
unless it was included in the original consent. 
Details on processes for collection and shipment and destruction of these samples can be found 
in the central laboratory manual. 

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RPT193 and placebo will be shipped and stored under controlled conditions according to the 
storage requirements. 
Refer to the pharmacy manual for full details for packaging, labelling, and shipment of the IP. 
6.3 
Blinding 
The study is double-blinded; therefore, the Investigators, study personnel, and the study subjects 
will remain blinded to treatment allocation. 
Randomization data will be kept strictly confidential, accessible only to authorized staff and the 
DMC until the time of unblinding. Authorized staff may include the randomization statistician, 
who will store the master randomization list in a secure system, an unblinded statistician, and 
unblinded programmers. All authorized unblinded staff must be documented. 
RPT193 and placebo will be coded and labelled in a manner that protects blinding. The coding 
system will permit rapid identification of the IP (in case of medical emergencies). 
The Investigator is responsible for study-related medical decisions and may break the blind, if 
knowledge of the IP is essential for the clinical management of the subject. The Investigator 
should make every effort to contact the Sponsor’s Medical Monitor prior to breaking the blind 
and must contact the Sponsor within 1 working day after the blind is broken, without revealing to 
the Sponsor (or clinical research organization [CRO]) the results of the code break, except to the 
designated global subject safety representative. Subjects whose treatment assignments are 
unblinded will not receive any further IP.  
Emergency unblinding will be organized through interactive voice response system/interactive 
web response system (IXRS) system. The Investigator must record the date of unblinding and the 
reason. All breaks of the blind must be adequately documented. 
If an SAE is reported, the designated global subject safety representative may unblind the 
treatment assignment for the individual subject through IXRS in order to meet regulatory 
reporting requirements. 
6.4 
Method of Assigning Treatment 
Each subject will have a unique subject number obtained from a centralized IXRS. This will be 
assigned at the Screening visit. The Investigator will keep a record (the subject screening log) of 
subjects who entered Screening. 
The unique subject identifier number will contain the site number (YYYY) and the subject 
number (SSSS) and will be assigned at the Screening visit (eg, 0401-5001). 
Randomization will be performed via the IXRS at the Baseline (Day 1) visit prior to dosing. On 
Baseline (Day 1), eligible subjects will be assigned to RPT193 or placebo in a 1:1 ratio. Each 
subject will receive a unique subject number when he/she is assigned treatment. Subjects will be 
allocated to treatment according to the randomization code. 

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Prior to Baseline (Day 1), eligibility will be monitored by Study Personnel with permission 
required prior to randomizing any subject. 
On Baseline (Day 1), subjects will be assigned a unique subject number by the IXRS. The 
subject number will encode the subject’s assignment to either RPT193 or placebo, according to 
the randomization code generated prior to the study. Once a subject number has been assigned, it 
cannot be reassigned to a different subject. 
Subjects will be stratified by pre-screening inhaled ICS + LABA (medium- or high-dose ICS) as 
well as by location of the Study Site (North America versus Europe). 
If a subject withdraws from the study, his/her unique identification number(s) cannot be re-used 
for another subject. 
6.5 
Reliever Bronchodilator 
A metered-dose inhaler (MDI) reliever with a SABA (eg, salbutamol, albuterol, levosalbutamol, 
or levoalbuterol) bronchodilator will be supplied by the site to all subjects in this study. Subjects 
may administer the SABA reliever bronchodilator as needed for asthma symptoms. Subjects will 
record if they have taken 6 or more distinct inhalations/puffs of SABA/quick-relief inhaler in the 
e-Diary daily. 
SABA therapy used for exercise pretreatment or for reversibility testing should not be considered 
as being used for asthma relief and should not count toward the number of puffs to be recorded 
in the e-Diary. Study sites should monitor reliever medication use during the study visits at the 
time points indicated in Table 1. 
If a subject were to receive a nebulized form of the SABA reliever, the following table converts 
nebulized salbutamol/albuterol to equivalent MDI puffs for use as part of the LOAC definition. 
Salbutamol/Albuterol Nebulizer Solution - 
Total Daily Dose (mg)  
Number of Puffs 
2.5 mg 
4 
5 mg 
8 
7.5 mg 
12 
10 
16 
6.6 
Dose and Administration 
RPT193-03 will investigate the efficacy and safety of RPT193 in subjects with T2-high 
moderate-to-severe asthma. The study will assess 1 dose level of RPT193 (400 mg) (or matching 
placebo) taken orally once daily for 14 weeks (98 days).  
6.6.1 
Dose Modification 
No IP dose modifications will be permitted during the study. 

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6.7.1 
Withdrawal of Background Inhaled Therapies 
Run-in and Adjunctive Therapy Periods: From the initiation of the Run-in period (Week -4) 
up to Day 42 (Week 6), clinically comparable doses of the study-specific ICS/LABA 
combination therapy with fluticasone/salmeterol, as approved per region. There is no withdrawal 
of background therapy during this period. 
Background Therapy Withdrawal Period: Salmeterol will be withdrawn at Day 43 (Week 6) 
post-randomization. Subjects will be switched from their twice daily fluticasone/salmeterol 
combination therapy to a clinically comparable ICS dose of fluticasone twice daily monotherapy, 
as approved for region. 
The ICS component (fluticasone) will then be subsequently withdrawn by a step-wise dose 
reduction starting at Day 57 (Week 8) based on inhaler therapy at the Screening Visit. The tables 
below summarize the management of background inhaled therapies for each subject class. 
For subjects initially taking medium-dose ICS + LABA: 
Period 
Visit(s) 
Inhaler to be Initiated (or Continued) at Visit 
1) Run-in 
Day -28 (Week – 4) through 
Day -1 (Week -1) 
Fluticasone/Salmeterol  250/50 mcg 1 puff twice 
daily  
2) Adjunctive 
Therapy 
Baseline (Day 1) through 
Day 42 (Week 6) 
3), 4), and 5) 
Background Therapy 
Withdrawal 
Day 43 (Week 6) through 
Day 56 (Week 8) 
Fluticasone 1 puff 250 mcg twice daily 
Days 57-63 (Week 8-9) 
Fluticasone 1 puff 100 mcg twice daily 
Days 64-70 (Week 9-10) 
Fluticasone 1 puff 50 mcg twice daily 
Day 71 (Week 10) through 
Day 98 (Week 14) 
Discontinue Fluticasone inhaler 
For subjects initially taking high-dose ICS + LABA: 
Period 
Visit(s) 
Inhaler to be Initiated (or Continued) at Visit 
1) Run-in 
Day -28 (Week -4) through 
Day -1 (Week -1) 
Fluticasone/Salmeterol  500/50 mcg 1 puff twice 
daily  
2) Adjunctive 
Therapy 
Baseline (Day 1) through 
Day 42 (Week 6) 
3), 4), and 5) 
Background Therapy 
Withdrawal 
Day 43 (Week 6) through 
Day 56 (Week 8) 
Fluticasone 2 puffs 250 mcg twice daily 
Days 57-63 (Week 8-9) 
Fluticasone 1 puff 250 mcg twice daily 
Days 64-70 (Week 9-10) 
Fluticasone 1 puff 100 mcg twice daily 
Days 71-77 (Week 10-11) 
Fluticasone 1 puff 50 mcg twice daily 
Day 78 (Week 11) through 
Day 98 (Week 14) 
Discontinue Fluticasone inhaler 
Subjects are to undergo each step in the withdrawal provided that subjects have not experienced 
a LOAC event. If a LOAC even occurs, subjects are to be withdrawn from study IP and managed 
as described in Section 5.2.1.   
Sites are to source the ICS/LABA during the Run-in and Adjunctive Therapy Periods as well as 
the ICS inhalers during the Background Therapy Withdrawal Period. If sites are not able to 
source inhalers, they should work with their CRO study team to obtain. If a supply interruption 
occurs, the study site should contact CRO study personnel immediately. 

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6.7.2 
Reliever Bronchodilator 
Details on the description, use, and management of reliever bronchodilator are found in 
Section 6.5. 
6.7.3 
Identifying a Loss of Asthma Control Event 
Subjects will be monitored for LOAC events using the internet-enabled e-Diary/PEF device 
which will allow real-time monitoring of subjects who meet the LOAC definition. In addition, 
subjects will be required to be seen at the study site and evaluated 2 weeks after the withdrawal 
of LABA and weekly during the ICS withdrawal and monotherapy periods. Site staff and 
Investigator will thoroughly evaluate whether the subject has met the criteria for LOAC based on 
review of e-Diary, PEF, medication usage, and medical history.  
6.7.4 
Managing a Loss of Asthma Control Event 
If a subject satisfies criteria for a LOAC event during any point after randomization, the subject 
will be discontinued from study IP and undergo an End of Treatment visit. Subjects will return to 
the background inhaled therapy used at Screening once a LOAC event has occurred. Escalation 
of therapy may also be considered at Investigator discretion. While subjects will discontinue 
study IP upon a LOAC event, subjects will continue in the study with safety follow-up for 
further clinical monitoring and adjustment of therapy as needed per Investigator discretion.   
6.8 
Prior Medication and Procedures 
Refer to the Inclusion and Exclusion criteria (Section 4) for a list of prior medications and 
procedures that may affect participation in this study. 
6.9 
Concomitant Medication and Procedures 
All medication (including vaccines, over-the-counter or prescription medicines, vitamins, and/or 
herbal supplements) taken from 30 days before start of screening until the end of the follow-up 
period will be recorded in the appropriate section of the eCRF. The following details must be 
recorded in the eCRF: 
• Medication name, ideally the generic name 
• Reason for use 
• Start and end date of administration 
• The dose and frequency of administration 
The Medical Monitor should be contacted if there are any questions regarding prior or 
concomitant medication or procedures. 
Please note that for any biologic medications (eg, dupilumab, mepolizumab, benralizumab, 
reslizumab, or omalizumab), documentation of prior exposure and duration of treatment should 
be provided even if more than 30 days prior to the start of screening. 

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Any instance of overdose (suspected or confirmed and irrespective of whether or not it involved 
RPT193) must be communicated to the Sponsor (or a specified designee) using the overdose 
eCRF page(s) within 24 hours of its occurrence. 
Any overdose associated with clinical symptoms will be recorded as an AE or SAE, as 
appropriate. Details of any signs or symptoms and their management should be recorded, 
including details of any treatments administered for the overdose. All overdoses with clinical 
symptoms meeting the SAE criteria must be reported as described in Appendix I. 
6.10.1 
Treatment of Overdose 
IP overdose is any accidental or intentional use of IP in an amount at least 2 times higher than 
the dose indicated per-protocol for a given subject. IP compliance (see Section 6.11) should be 
reviewed to detect potential instances of overdose (intentional or accidental). 
The Sponsor must be immediately notified of any instances of overdose and a protocol deviation 
must be thoroughly documented and reported per local regulations. Any IP overdose during the 
study should be recorded on the source document and eCRF. The excess quantity and duration of 
the overdose should be recorded. 
In the event of overdose, the subject should be closely monitored for any potential AEs. All AEs 
associated with an overdose should be entered on the Adverse Event eCRF. If the associated AE 
fulfills serious criteria, the event should be reported to the Sponsor or designee within 24 hours 
of awareness of the event. Any AEs or SAEs associated with an overdose will be reported using 
the procedures detailed in Appendix I.  
6.11 
Compliance 
The Investigator (or designee) will explain the correct use of the IP to each subject and will 
check that each subject is following the instructions properly. Compliance will be assessed at 
each visit by direct questioning and will be documented in the source documents and eCRF. Any 
deviation from the correct use of the IP will be recorded in the eCRF.  
A record of the number of IP tablets dispensed to and taken by each subject will be maintained 
and reconciled with IP and compliance records. The IP start and stop dates, including dates for IP 
delays and/or dose reductions, will also be recorded in the eCRF. 
At study visits, subjects will be administered IP by the Investigator or site personnel, under 
medical supervision. The date and time of each dose administered in the clinic will be recorded 
in the source documents and in the eCRF. In addition, subjects will capture the date and time of 
dosing in a daily e-Diary when the IP is taken at the site or at home.  
Treatment compliance will be assured by site reconciliation of all IP supplies and comparing the 
number of tablets taken with the number planned to be taken.  
The Investigator (or designee) will explain the correct use of the Non-Investigational Medicinal 
Products (fluticasone, fluticasone/salmeterol, salmeterol) to each subject and will check that each 
subject is following the instructions properly. Compliance will be assessed at each visit by direct 

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questioning and if available, the mechanical counter present on the inhaler device, and will be 
documented in the source documents. 
Subjects who are significantly noncompliant with IP or Non-Investigational Medicinal Product 
treatment (ie, missing > 20% of doses) will be counseled and could be discontinued from the 
study, at the discretion of the Investigator, following consultation with the Sponsor. A subject 
will also be considered significantly noncompliant if he or she intentionally or repeatedly takes 
more than the prescribed amount of IP in the same time frame, as judged by the Investigator. 
6.12 
Accountability 
The IP must not be used for any purpose other than that defined in this protocol. All supplies of 
IP will be accounted for in accordance with Good Clinical Practice (GCP). 
The Investigator, a member of the study staff, institution, or a hospital pharmacist (where 
applicable) must maintain accurate records of all IP supplies received during the study. These 
records should include the dates and amounts of IP that were received at the site, dispensed, and 
destroyed or returned to the Sponsor (or designee). The records should include dates, quantities, 
batch numbers, expiration dates (if applicable), and the unique code (kit) numbers assigned to the 
IP and study subjects. If errors or damage in the IP shipments occur, the Investigator should 
contact the Sponsor (or its designee) immediately. Copies of the IP accountability records will be 
provided by each Investigator for inclusion in the trial master file (TMF). The study monitor will 
periodically check the supplies of IP held by the Investigator, member of the study staff, or 
pharmacist to verify accountability of the IP used. 
The Investigator (or designee) will administer the IP only to the identified subjects in this study, 
according to the procedures described in this study protocol. Details of IP administered to 
subjects will be recorded in the eCRF. Investigators should maintain records that document 
adequately that the subjects were provided the doses specified by the protocol and reconcile all 
IP received from the Sponsor (or designee). 
After the end of the study, all unused IP and all medication containers should be destroyed at the 
study center or returned to the Sponsor (or designee) for destruction. In either instance, complete 
documentation will be returned to the Sponsor. The IP initial and resupply will be managed by 
the IXRS. 

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7 STUDY PROCEDURES 
• Study procedures and their timing are summarized in Table 1. 
• Protocol waivers or exemptions are not allowed. 
• Immediate safety concerns should be discussed with the Medical Monitor and Sponsor 
immediately upon occurrence or awareness to determine if the subject should continue or 
discontinue IP. 
• Adherence to the study design requirements, including those specified in Table 1, 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, as 
applicable.  
• The maximum amount of blood collected from each subject over the duration of the study, 
not including any extra assessments that may be required, will be specified in the ICF. 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with 
the samples. 
• Demographic information related to age and ethnicity will be collected at screening. 
• The clinical trial consists of 5 distinct periods during the treatment portion of the study: 
• Period 1) Screening (up to 2 weeks)/Run-in (4 weeks): Subjects will be enrolled and 
assessed for initial eligibility. At Day -28, subjects will begin standardized background 
inhaled therapy commensurate with each subject’s inhaled therapy at Screening (See 
Appendix V – Section 17.5). In addition to continued assessment of eligibility, subjects 
will be assessed for compliance with medication and e-Diary entries. Eligibility will be 
monitored by the study team with permission for randomization required beforehand. 
• Period 2) Randomization and adjunctive therapy with study IP (Baseline [Day 1] to 
Day 42): Subjects will self-administer study IP once daily in conjunction with 
medium- or high-dose ICS + LABA. 
• Periods 3) and 4) Background Therapy Withdrawal (Day 43 to Day 71 or Day 78 
[Week 6 to Week 10 or Week 11]): Provided that a subject has not had a LOAC event, 
each subject will undergo withdrawal of background therapy starting at the Day 43 
(Week 6) visit. At Day 43 (Week 6), LABA will be withdrawn for 2 weeks. Beginning 
at the Day 57 (Week 8) visit, ICS withdrawal will be initiated in a step-wise fashion.  
For subjects on medium-dose ICS + LABA at Screening, the withdrawal will be 
completed at the Week 10 visit. For subjects on high-dose ICS + LABA at Screening, 
the withdrawal will be completed at the Day 78 (Week 11) visit. 
If a subject satisfies criteria for a LOAC event during any point after randomization, the 
subject will be discontinued from study IP and undergo an End of Treatment visit. 

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8 ADVERSE EVENTS 
8.1 
Definitions 
8.1.1 
Adverse Events 
The definition of an AE can be found in Appendix I. 
AEs will be reported by the subject (or, when appropriate, by a caregiver, surrogate, or the 
subject’s legally authorized representative). 
The Investigator and any designees are responsible for detecting, documenting, and recording 
events that meet the definition of an AE or SAE and remain responsible for following up AEs 
that are serious, considered related to the IP or study procedures, or that caused the subject to 
discontinue the IP or withdraw from the study (see Section 4.4).  
8.1.2 
Serious Adverse Events 
The definition of an SAE can be found in Appendix I. 
8.1.3 
Suspected Unexpected Serious Adverse Reactions 
A suspected unexpected serious adverse reaction (SUSAR) is defined as an untoward and 
unintended response to an IP, which is not listed in the IB as an expected AE, and meets one of 
the following serious criteria: results in death, is life threatening, requires hospitalization or 
prolongation of an existing hospitalization, results in persistent or significant disability or 
incapacity, or is a congenital anomaly or birth defect; and is assessed as causally related to 
the IP. 
8.2 
Time Period and Frequency for Collecting AE and SAE Information  
Adverse events and SAEs will be collected from the signing of the ICF until Extended 
Follow-up/Visit 14 or 42 days after the last dose of IP if a subject withdraws from the study.  
All SAEs will be recorded and reported to the Sponsor or designee within 24 hours of the 
Investigator’s awareness of the event, as indicated in Appendix I. The Investigator will submit 
any updated SAE data to the Sponsor within 24 hours of receipt of the information. 
Investigators are not obligated to actively seek AE or SAE after conclusion of the study 
participation. However, if the Investigator learns of any SAE, including a death, at any time after 
a subject has withdrawn from the study, and he/she considers the event to be reasonably related 
to the IP or study participation, the Investigator must promptly notify the Sponsor. 
The method of recording, evaluating, and assessing causality of AE and SAE and the procedures 
for completing and transmitting SAE reports are provided in Appendix I. 

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8.3 
Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the subject is the preferred method to inquire about 
AE occurrences. 
8.4 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the Investigator is required to proactively follow each subject at 
subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, the event is 
otherwise explained, or the subject is lost to follow-up (as defined in Section 4.4.5. Further 
information on follow-up procedures is given in Appendix I. 
8.5 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the Investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects and the safety of the IP 
under clinical investigation are met.  
• The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of the IP under clinical investigation. The Sponsor will 
comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRBs/IECs, and Investigators. 
• Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and Sponsor policy and forwarded to Investigators as necessary. The approved 
IB reference safety information (RSI) will be used by Sponsor or Sponsor designee for 
determining the expectedness of a serious, related AE. If the event is not included in the RSI, 
the case will be considered a SUSAR and submitted as required to applicable the competent 
authorities (i.e. EMA, FDA). 
• In the US and EU, SUSARs are to be reported to the regulatory authorities within 15 
calendar days of initial notification to Sponsor or its designee. If the suspected adverse 
reaction is serious, unexpected, and is fatal or life threatening, the event will also be reported 
per required mode of communication to the regulatory authorities within 7 calendar days. 
• In the EU, SUSARs will be reported to all participating Member States through the 
Eudravigilance database and local regulatory authorities if applicable. 
• An Investigator who receives an Investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will review 
and then file it along with the Investigator’s Brochure and will notify the IRB/IEC, if 
appropriate according to local requirements. 
8.6 
Adverse Events of Clinical Interest 
 

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9 STATISTICS 
9.1 
General Procedures 
This section is a summary of the planned statistical analyses of the most important endpoints 
including primary and key secondary endpoints. 
The SAP will provide a detailed description of the statistical methods and expand on the details 
provided in the protocol. The SAP will be approved prior to any lock of the study database and 
unblinding of the study data.  
All personnel involved with the analysis of the study will remain blinded until database lock and 
identification of protocol deviations. Analyses will be performed using SAS® (SAS Institute, 
Cary, NC, US) by the Sponsor or its representatives. 
All data will be presented by treatment group. Descriptive statistics (number of observations, 
mean, standard deviation [SD], median, minimum, and maximum) will be provided for 
continuous variables, and counts and percentages will be presented for categorical variables. 
Baseline is defined as the last non-missing measurement before or on the date of first 
administration of IP. 
9.2 
Analysis Populations 
The Enrolled Analysis Set (EAS) will include all subjects who provide informed consent. This 
analysis set will be used to report disposition and screening failures. 
The Full Analysis Set (FAS) will include all randomized subjects and will be analyzed according 
to randomized treatment following the intention to treat (ITT) approach, regardless of which 
treatment they actually received (RPT193 or placebo). This analysis set will be the primary set 
used for analyses/summaries of the primary efficacy endpoint, as well as for all secondary and 
other efficacy endpoints. 
The Safety Analysis Set (SAS) will include all subjects who receive at least 1 dose of IP and will 
be analyzed according to actual treatment. This analysis set will be used for summaries of safety 
data.  
The Per-Protocol Analysis Set (PPAS) will include all subjects in the FAS who do not have an 
important protocol deviation that could affect the primary endpoint. Important protocol 
deviations that could affect the primary endpoint will be defined and agreed upon before 
unblinding. This analysis set will be used for sensitivity analyses. 
The PK Analysis Set (PKAS) will include all subjects who receive at least 1 dose of IP and 
enough bioanalytical assessments to calculate reliable estimates of the PK parameters. 
The Pharmacodynamic (PD) Analysis Set (PDAS) will include all subjects in the Safety Set for 
whom the PD data are sufficient and interpretable. 

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9.4.3 
Exploratory Endpoints 
Refer to Section 2. 
Exploratory endpoints will be analyzed using descriptive statistics. 
9.4.4 
Safety Endpoints 
The SAS will be used for the analysis of safety data (AEs, exposure to IP, clinical laboratory, 
vital signs, and ECGs). 
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).  
TEAEs are defined as AEs with an onset date on or after the date of first administration of IP and 
before the date of last administration of IP. TEAEs will be presented by system organ class 
(SOC) and preferred term in frequency tables. Subjects with multiple AEs will be counted only 
once within each preferred term and SOC.  
Key subject information for subjects with an AE with an outcome of death, subjects with SAEs, 
and subjects with AEs leading to discontinuation of IP will be listed. 
Laboratory data (hematology, serum chemistry, and urinalysis) will be converted to 
Système International units for reporting and processing purposes. Absolute values and changes 
from baseline will be presented descriptively. For continuous variables, descriptive statistics 
(n, mean, standard deviation, median, minimum, and maximum) will be provided for actual 
values and changes from baseline to each time point. For categorical variables, subject counts 
and percentages will be provided. Descriptive summaries of SAEs, AEs leading to treatment 
discontinuation, and potentially clinically significant abnormal values (clinical laboratory or vital 
signs) based on predefined criteria will be provided as well. 
Vital signs and ECG parameters will be presented descriptively. 
9.4.5 
Demographic and Baseline Characteristics 
Demographic characteristics (including age, sex, ethnicity, and race) and baseline characteristics 
(including height, weight, BMI, and disease characteristics) will be presented descriptively. 
9.4.6 
Pharmacokinetic Endpoints 
Individual and mean plasma concentrations at each sampling time point for RPT193 will be 
listed and summarized in a tabular format including means, geometric means, ranges, SDs, and 
coefficients of variation (CVs). Mean and/or median concentrations will be plotted versus time 
on semilogarithmic scales. 
PK parameters will be calculated using noncompartmental analysis. Summary statistics of PK 
parameters including means, geometric means, medians, ranges, SDs, and CVs will be presented. 

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9.4.7 
Pharmacodynamic Endpoints 
All PD data will be summarized using descriptive statistics and will be listed and summarized in 
tabular and/or graphical format. Statistical analysis will be performed on PD parameters to 
compare the treatment groups. 
9.4.8 
Subgroup Analyses 
To explore the uniformity of the detected overall treatment effect on the primary, and when 
applicable, key secondary efficacy endpoints, subgroup analyses may be performed. The 
following subgroup analyses are planned to be performed using a repeat of the analysis method 
used for the primary endpoint: 
• Age group: based on the median age of the Full Analysis Set 
• Sex: female vs. male 
• Background ICS + LABA at Screening: Medium- or high-dose ICS 
• Study Site: North America vs Europe 
Full details of the subgroup analyses will be prespecified in the SAP. 
9.4.9 
Handling of Missing Values 
Rules for imputation of missing data will be detailed in the SAP. 
Subjects who withdraw from the study will be evaluated based on the data collected at each visit 
attended. Data collected during the withdrawal visit will be used as an end of study assessment 
for these subjects. If the withdrawal visit was performed > 1 day after the last dose was 
administered, then the previous visit will be used as the end of study assessment. 
9.5 
Interim Analysis 
No interim analysis is planned. 

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10 ETHICS AND RESPONSIBILITIES 
10.1 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the Note for Guidance on GCP International 
Council for Harmonisation (ICH) Harmonised Tripartite Guideline E6 (R1)/Integrated 
Addendum E6 (R2); US FDA CFR (Title 21 Parts 50, 56, 312); the general guidelines indicated 
in the Declaration of Helsinki; and all applicable regulatory requirements including, with respect 
to the conduct of the study in the EU, Regulation (EU) No. 536/2014 of the European Parliament 
and the Council of the European Union. 
In accordance with the requirements of the Regulation No. 536/2014 of the European Parliament 
and the Council of the European Union, the Sponsor will obtain approval from the Competent 
Authorities of the EU Member States and/or Ethics Committees, as applicable, for any 
amendments to the study that are deemed as “substantial” (i.e., changes which are likely to have 
a significant impact on the safety or physical or mental integrity of the study participants or on 
the scientific value of the study) prior to their implementation at European sites. 
10.2 
Institutional Review Board/Independent Ethics Committee 
Before initiating a study, the Investigator/institution must have written and dated 
approval/favorable opinion from the IRBs/IECs for the study protocol/amendment(s), written 
ICF, any ICF updates, subject recruitment procedures (eg, advertisements), and any written 
information to be provided to subjects and a statement from the IRBs/IECs that these comply 
with GCP requirements (if applicable). A current copy of the IB should be included as part of the 
written application to the IRB/IEC. 
The IRB/IEC approval(s) must identify the protocol version as well as the documents reviewed. 
Any amendments to the protocol will require IRB/IEC approval before the implementation of the 
changes made to the study, except for changes necessary to eliminate an immediate hazard to the 
study subjects. 
The Investigator will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by the 
IRB/IEC 
• Notifying the IRB/IEC of SAEs or other significant safety findings, including adverse drug 
reactions (ADRs) that are both serious and unexpected, as required by IRB/IEC procedures 
• Providing oversight of the conduct of the study at the site and adherence to the requirements 
of 21 CFR, ICH guidelines, the applicable IRB/IEC, and all other applicable regulations 
including, for European sites, Regulation (EU) No. 536/2014. 
• Promptly reporting deviations from, or changes to, the protocol to eliminate immediate 
hazards to the study subjects 

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10.3 
Informed Consent 
In obtaining and documenting informed consent, the Investigator should comply with the 
applicable regulatory requirement(s) and should adhere to GCP and to the ethical principles that 
have their origin in the Declaration of Helsinki. Prior to the beginning of the study, the 
Investigator should have the IRB/IEC’s written approval/favorable opinion of the written ICF 
and any other written information to be provided to subjects. 
• The Investigator or his/her representative will explain the purpose and nature of the study as 
well as possible adverse effects to the subject or his/her legally acceptable representative and 
answer all questions regarding the study. 
• Subjects must be informed that their participation is voluntary, and consent can be withdrawn 
at any point. 
• Subjects or their legally acceptable representatives will be required to sign a statement of 
informed consent that meets the requirements of US FDA CFR Title 21 Part 50, local 
regulations, ICH guidelines, the Health Insurance Portability and Accountability Act 
(HIPAA) in the US, Regulation (EU) No. 536/2014 in Europe, and the applicable IRB/IEC 
for the study site.  
• Prior to a subject’s participation in the study, the written ICF should be signed and personally 
dated by the subject or by the subject’s legally acceptable representative, and by the person 
who conducted the informed consent discussion. 
• The medical record must include a statement that written informed consent was obtained 
before the subject was enrolled in the study and the date the written consent was obtained. 
• The original copy of the signed ICF will be retained at the study site. 
• A copy of the ICF and any other written information must be provided to the subject or the 
subject’s legally acceptable representative. 
• If the ICF is revised, the revised ICF must have received the IRB/IEC’s approval/favorable 
opinion in advance of its use. Subjects must be informed of the changes to the ICF and must 
re-consent to the most current version during their participation in the study. The subject or 
the subject’s legally acceptable representative should be informed in a timely manner if new 
information becomes available that may be relevant to the subject’s willingness to continue 
participation in the study. The communication of this information should be documented. 
Subjects who are rescreened are required to sign a new ICF. 
Provision of separate informed consent is mandatory for the genetic research. The subjects will 
be informed about its purpose and confidentiality of test results, and will be asked for their 
authorization to perform the test. If the subject does not consent to the blood sample for genetic 
testing, they may still participate in the study but will not have a sample taken for the genetic 
testing.  

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The ICF will contain a separate section that addresses the use of remaining mandatory samples 
for optional exploratory research. The Investigator (or authorized designee) will explain to each 
subject the objectives of the exploratory research. Subjects will be told that they are free to 
refuse to participate and may withdraw their consent at any time and for any reason during the 
storage period. A separate signature will be required to document a subject’s agreement to allow 
any remaining specimens to be used for exploratory research. Subjects who decline to participate 
in this optional research will not provide this separate signature. 
By signing the ICF, the witness attests that the information in the ICF and any other written 
information was accurately explained to, and apparently understood by, the subject or the 
subject’s legally acceptable representative, and that informed consent was freely given by the 
subject or the subject’s legally acceptable representative. 
When a clinical study (therapeutic or non-therapeutic) includes subjects who can only be 
enrolled in the study with the consent of the subject’s legally acceptable representative 
(e.g., minors or subjects with severe dementia), the subject should be informed about the study to 
the extent compatible with the subject’s understanding and, if capable, the subject should sign 
and personally date the written informed consent. 
10.4 
Data Protection 
All subject data will be recorded, processed, stored, and handled in such a way that it can be 
accurately reported, interpreted, and verified, while preserving the confidentiality of the records 
and protecting the information and personal data of all subjects in accordance with applicable 
data protection laws including, for subjects located in the EU, the General Data Protection 
Regulation (GDPR) and applicable Member State laws. The subject personal data that will be 
collected in the study includes health information, date of birth, age, sex, race, and ethnicity.  
Appropriate technical and organizational measures shall be implemented and maintained to 
protect information and personal data of subjects processed against unauthorized or unlawful 
access, disclosure, dissemination, alteration, destruction or accidental loss, including the 
following: 
• Study subjects will be assigned a unique subject identification number.  Any study 
records or datasets that are transferred by the investigative site will contain the subject 
identification number only; subject names and any information that would make the 
subject personally identifiable (e.g., phone number, address) will be redacted in all 
records and data before they are transferred by the investigative site.  
• Information technology systems used to collect, process, and store study-related data will 
be secured by technical and organizational security measures designed to protect such 
data against accidental or unlawful loss, alteration, or unauthorized disclosure or access 
• The Sponsor will implement data security controls which include, at a minimum, logical 
segregation of data, restricted (e.g. role-based) access and monitoring, password controls, 
and utilization of commercially available industry standard encryption technologies for 
subject personal data that is transmitted over public networks (i.e. the Internet) or when 
transmitted wirelessly or stored on portable or removable media (i.e. laptop computers, 
CD/DVD, USB drives, back-up tapes). 

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• The contract between the Sponsor, Investigators, and study sites will specify the 
responsibilities of the parties related to the handling of data security breaches and the 
respective communication and cooperation of the parties. The Investigators and the study 
sites will be required to notify the Sponsor without undue delay of becoming aware of 
any data security breaches in relation to subject personal data and detail in the 
notification the nature of the breach and other information to allow the Sponsor to assess 
the personal data breach in accordance with applicable data protection laws.   
• The Investigators and study sites will be obligated to provide reasonable assistance to the 
Sponsor in ensuring the Sponsor’s fulfilment of its obligations in respect of personal data 
breaches under applicable data protection laws, including reporting the personal data 
breach to study subjects and/or regulatory authorities if and as required by applicable data 
protection laws. The Sponsor will work with Investigators and study sites to investigate 
any data breach incidents involving subject personal data, take appropriate actions to 
remedy and mitigate such incidents and, as applicable, take measures to prevent similar 
data security breaches in the future. 
• The Investigator or his/her designee must explain to each subject, before enrollment into 
the study, that, for evaluation of study results, the subject’s confidential medical 
information obtained during the study and medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities. The 
Investigator (or designee) is responsible for obtaining written permission from subjects 
for the use and disclosure of their confidential medical information as described in the 
informed consent and/or data privacy authorization in accordance with country-specific 
regulations (such as the Health Insurance Portability and Accountability Act in the US 
and the GDPR in the EU) before they are allowed to participate in the study. If 
permission to use and disclose confidential medical information is withdrawn by a 
subject, the Investigator is responsible for documenting that no further personal data from 
the subject will be collected unless required by applicable law. 
10.5 
Financing and Insurance  
10.5.1 
Contractual and Financial Details 
The Investigator (and/or, as appropriate, the hospital administrative representative) and the 
Sponsor will sign a clinical study agreement prior to the start of the study, outlining overall 
Sponsor and Investigator responsibilities in relation to the study. The contract should describe 
whether costs for pharmacy, laboratory, and other protocol-required services are being paid 
directly or indirectly. 
10.5.2 
Insurance, Indemnity, and Compensation 
The Sponsor will maintain an appropriate clinical study insurance policy. 

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10.5.3 
Financial Disclosure 
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information as requested to allow the Sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. 

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11 RECORDS MANAGEMENT 
All clinical study information should be recorded, handled, and stored in a way that allows its 
accurate reporting, interpretation, and verification. This principle applies to all records 
referenced in this protocol, irrespective of the type of media used. 
An eCRF will be used to store and transmit subject information. The eCRF must be reviewed 
and electronically signed and dated by the Investigator. The Investigator is responsible for 
verifying that the data entries are accurate and correct by signing the eCRF. 
Access to the eCRF will be strictly password protected and limited to personnel directly 
participating in the study. Data should be entered into the eCRF completely by authorized site 
personnel (eg, Investigators and the study coordinator). The eCRF must be completed as soon as 
possible after any subject evaluation or communication. If data are to be changed due to 
erroneous input or other reason, an electronic audit trail will track these changes. The eCRFs and 
computers that store them must be accessible to study monitors and other regulatory auditors. 
During each study visit, a physician participating in the study will maintain progress notes in the 
subject’s medical records to document all significant observations. At a minimum, these notes 
are to contain: 
• The date of the visit and the corresponding day or visit in the study schedule 
• General condition and status remarks by the subject, including any significant medical 
findings. The severity, frequency, duration, and resolution of any reported AE, and the 
Investigator’s assessment as to whether or not the reported AE is related to IP 
• Changes (including dosages) in concomitant medications/therapies (including medical foods) 
or procedures 
• A general reference to the procedures completed 
• The signature or initials of all physicians making an entry in the medical record (progress 
notes) 
In addition, any contact with the subject via telephone or other means that provides significant 
clinical information is to also be documented in the medical record (progress notes), as described 
above. 
Information from the medical records (progress notes) and other source documents is to be 
promptly entered into the appropriate section of the eCRF. 
Changes to information in the medical record (progress notes) and other source documents are to 
be initialed and dated on the day the change is made by the Investigator (or designee). If the 
reason for the change is not apparent, a brief explanation for the change is to be written adjacent 
to the change. Changes to the eCRF will be electronically tracked. 

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Records must be retained in accordance with the current ICH Guidelines on GCP. All essential 
study documents, including records of subjects, source documents, eCRFs, and the IP inventory, 
must be kept on file. 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated marketing 
applications in an ICH region, or until at least 2 years have elapsed since the formal 
discontinuation of clinical development of RPT193. However, essential documents may be 
retained for a longer period if required by the applicable regulatory requirements or by 
agreement with the Sponsor. The Sponsor is responsible for informing the Investigator when 
these documents need no longer be retained. 
The Investigator is not to dispose of any records relevant to this study without written permission 
from the Sponsor and is to provide the Sponsor the opportunity to collect such records. The 
Investigator shall take responsibility for maintaining adequate and accurate hard copy source 
documents of all observations and data generated during this study. Such documentation is 
subject to inspection by the Sponsor, its representatives, and regulatory authorities. 
If an Investigator moves, withdraws from a study, or retires, the responsibility for maintaining 
the records may be transferred to another person who will accept responsibility. Notice of 
transfer must be made to and agreed by the Sponsor. 

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12 AUDITING AND MONITORING 
Sponsor-assigned monitors will conduct regular site visits to the investigational facilities for the 
purpose of monitoring various aspects of the study, such as assessing subject enrollment, 
compliance with protocol procedures, completeness and accuracy of data entered into the eCRFs, 
verification of eCRF data against original source documents, and occurrence of AEs. The 
Investigator must agree to Sponsor-authorized personnel having direct access to the clinical (or 
associated) files and clinical study supplies (dispensing and storage areas) to ensure compliance 
with applicable regulations, and the Investigator will assist with the Sponsor’s monitoring 
activities. 
Quality control will occur at each stage of data handling to ensure that all data are reliable and 
have been processed correctly. The Sponsor should ensure oversight of any study-related duties 
and functions carried out on its behalf, including study-related duties and functions that are 
subcontracted to another party by the Sponsor’s contracted CRO(s). 
The eCRFs should be completed in a timely manner and on an ongoing basis to allow regular 
review by the study monitor. 
Details describing the strategy, responsibilities, and requirements of the study monitoring are 
provided in the study monitoring plan. 
The purpose of an audit is to assess whether ethics, regulatory, and quality requirements are 
being fulfilled. The Sponsor or its representative may conduct audits at the investigative sites 
including, but not limited to, IP supply, presence of required documents, the informed consent 
process, and comparison of eCRFs with source documents. Government regulatory authorities 
may also inspect the Investigator during or after the study. The Investigator (or designee) should 
contact the Sponsor/CRO immediately if this occurs. All medical records (progress notes) must 
be available for audit. The Investigator must agree to participate with audits conducted at a 
convenient time in a reasonable manner. 
12.1 
Risk and Quality Tolerance Limits 
Perceived risks and quality tolerance limits (QTLs) will be identified and documented before the 
start of the study. 
The Sponsor will review risk control measures periodically to ascertain whether the implemented 
quality management activities remain effective and relevant. The quality management approach 
and any important deviations from the predefined QTLs (and remedial actions adopted) will be 
described in the Clinical Study Report (CSR). 
12.2 
Protocol Adherence and Deviations 
The Investigator and site personnel should conduct the study in compliance with the protocol and 
should use continuous vigilance to identify and report protocol deviations. 
A protocol deviation is any change, divergence, or departure from the study design or procedures 
defined in the protocol that may be on the part of the Investigator, site personnel, or the subject. 

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Important protocol deviations are a subset of protocol deviations that may significantly impact 
the completeness, accuracy, and/or reliability of the study data or that may significantly affect a 
subject’s rights, safety, or well-being. For example, important protocol deviations may include 
enrolling subjects in violation of key eligibility criteria designed to ensure a specific subject 
population or failing to collect data necessary to interpret primary endpoints, as this may 
compromise the scientific value of the study. 
The Investigator should not implement any deviation from the protocol. In the event of an 
important protocol deviation, the Investigator will discuss the deviation with the Sponsor’s 
Medical Monitor and will come to an agreement as to whether the subject should be withdrawn 
from the study due to the important protocol deviation. 

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13 STUDY REPORT AND PUBLICATIONS 
This study will be registered on ClinicalTrials.gov in accordance with applicable laws or 
publication policy and may also be registered on other publicly accessible websites as necessary. 
The Sponsor is responsible for preparing and providing the appropriate regulatory authorities 
with the CSR according to the applicable regulatory requirements. The Sponsor will ensure that 
the CSR meets the standards of the ICH Guideline for Structure and Content of Clinical Study 
Reports (ICH E3). 
The publication policy of the Sponsor is discussed in the Investigator’s clinical research 
agreement.  
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. 
This allows the Sponsor to protect proprietary information and to provide comments. 
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating Investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee of 
Medical Journal Editors authorship requirements. 

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14 STUDY START AND TERMINATION 
The study start date is the date on which the first subject provides informed consent.  
The end of the study is defined as the last subject’s last assessment.  
Both the Sponsor and the Investigator reserve the right to terminate the study or the participation 
in the study at an Investigator’s site at any time. In terminating the study, the Sponsor and the 
Investigator will assure that adequate consideration is given to the protection of the subjects’ 
interests. 
If the study is prematurely terminated or suspended for any reason, the Sponsor/Investigator/site 
personnel should promptly inform the study subjects and should ensure appropriate therapy and 
follow-up for the subjects. Where required by the applicable regulatory requirements, the 
IRB/IEC should be informed promptly and be provided with a detailed written explanation of the 
termination or suspension. 
If the Investigator terminates or suspends a study without prior agreement of the Sponsor, the 
Investigator should inform the site personnel. The Investigator/site personnel should promptly 
inform the Sponsor and the IRB/IEC. The Investigator/site personnel should also provide the 
Sponsor and the IRB/IEC a detailed written explanation of the termination or suspension. 

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Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil 
levels. N Engl J Med. 2013;368:2455-66.  
Woodruff PG, Modrek B, Choy DF, et al. T-helper type 2-driven inflammation defines major 
subphenotypes of asthma. Am J Respir Crit Care Med. 2009;180:388-95. Erratum in: Am J 
Respir Crit Care Med. 2009;180:796.  
Zhudenkov K, Palmér R, Jauhiainen A, et al. Longitudinal FEV1 and exacerbation risk in COPD: 
quantifying the association using joint modelling. Int J Chron Obstruct Pulmon Dis. 
2021;16:101-11. 

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17 APPENDICES 
17.1 
Appendix I - Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting 
Definition of AE 
AE Definition 
• 
An AE is any untoward medical occurrence in a subject administered an IP and which does not necessarily have a causal 
relationship with that IP.  
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease (new or exacerbated) temporally associated with the use of IP, whether or not considered 
related to the IP. 
 
Events Meeting the AE Definition  
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, 
radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the Investigator (ie, not related to progression of underlying disease). 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity 
of the condition. 
• 
New condition detected or diagnosed after IP administration even though it may have been present before the start of the 
study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either IP or a concomitant medication. Overdose per 
se will not be reported as an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming intent. 
Such overdoses should be reported regardless of sequelae. 
• 
“Lack of efficacy” or “failure of expected pharmacological action” per se will not be reported as an AE or SAE. Such 
instances will be captured in the efficacy assessments. However, the signs, symptoms, and/or clinical sequelae resulting 
from lack of efficacy will be reported as AE or SAE if they fulfil the definition of an AE or SAE.  
 
Events NOT Meeting the AE Definition  
• 
Any clinically significant abnormal laboratory findings or other abnormal safety assessments which are associated with 
the underlying disease, unless judged by the Investigator to be more severe than expected for the subject’s condition. 
• 
Because worsening of asthma is captured by efficacy assessments, it will not be recorded as an AE, unless more severe 
than expected for the subject’s condition. 
• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to the procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study 
that do not worsen. 
 
Definition of TEAE 
TEAE Definition 
• 
A TEAE is any condition that was not present prior to treatment with the IP but appeared following treatment, was 
present at IP initiation but worsened during treatment, or was present at IP initiation but resolved and then reappeared 
while the individual was on treatment (regardless of the intensity of the AE when the IP was initiated). 
 

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Recording and Follow-up of AE and/or SAE 
AE and SAE Recording 
• 
When an AE/SAE occurs, it is the responsibility of the Investigator to review all documentation (eg, hospital progress 
notes, laboratory reports, and diagnostics reports) related to the event. 
• 
The Investigator will then record all relevant AE/SAE information in the CRF. Each event must be recorded separately. 
• 
It is not acceptable for the Investigator to send photocopies of the subject’s medical records to the Sponsor and/or 
designee in lieu of completion of the applicable AE/SAE CRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by the Sponsor and/or designee. 
In this case, all subject identifiers, with the exception of the subject number, will be redacted on the copies of the medical 
records before submission to the Sponsor and/or designee. 
• 
The Investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or other clinical 
information. Whenever possible, the diagnosis (not the individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
The Investigator will make an assessment of severity for each AE reported during the study. AEs should be assessed and 
graded for severity based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
v5.0 (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf).  
Toxicities that are not specified in the NCI-CTCAE will be graded for severity as follows: 
• 
Grade 1 (Mild): Asymptomatic or mild symptoms; clinical or diagnostic observation only; intervention not indicated 
• 
Grade 2 (Moderate): Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental 
activities of daily living (ADL) 
• 
Grade 3 (Severe): Medically significant but not immediately life-threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care ADL 
• 
Grade 4 (Life-threatening): Urgent intervention indicated required to remove or abrogate risk of death 
• 
Grade 5: Death related to AE 
Note: The terms “severe” and “serious” are not synonymous. Severity is a measure of intensity (as characterized above) 
whereas seriousness as defined above, defines the requirements for reporting obligations from the Sponsor to applicable 
regulatory authorities. 
Assessment of Causality 
The Investigator will establish causality of the AE to the IP. The Investigator should take into account the history of the 
subject, most recent physical examination findings, and concomitant medications.  
The following definitions will be used to determine causality of an AE:  
• 
Definitely Related: There is clear evidence to suggest a causal relationship, and other possible contributing factors can be 
ruled out. The clinical event, including an abnormal laboratory test result, occurs in a plausible time relationship to IP 
administration and cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of 
the IP (dechallenge) should be clinically plausible. The event must be pharmacologically or phenomenologically 
definitive, with use of a satisfactory rechallenge procedure if necessary. 
• 
Probably Related: There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. The 
clinical event, including an abnormal laboratory test result, occurs within a reasonable time after administration of the IP, 
is unlikely to be attributed to concurrent disease or other drugs or chemicals, and follows a clinically reasonable response 
on withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition. 
• 
Potentially Related: There is some evidence to suggest a causal relationship (eg, the event occurred within a reasonable 
time after administration of the IP). However, other factors may have contributed to the event (eg, the subject’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it can be 
flagged as requiring more information and later be upgraded to “probably related” or “definitely related”, as appropriate. 
• 
Unlikely to be Related: A clinical event, including an abnormal laboratory test result, whose temporal relationship to IP 
administration makes a causal relationship improbable (eg, the event did not occur within a reasonable time after 

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17.6 
Appendix VI – COVID-19 Severity Criteria 
Asymptomatic or Presymptomatic Infection 
Asymptomatic SARS-CoV-2 infection can occur, although the percentage of patients who remain truly 
asymptomatic throughout the course of infection is variable and incompletely defined. It is unclear what 
percentage of individuals who present with asymptomatic infection progress to clinical disease. Some 
asymptomatic individuals have been reported to have objective radiographic findings consistent with 
COVID-19 pneumonia. 
Mild Illness 
Patients with mild illness may exhibit a variety of signs and symptoms (eg, fever, cough, sore throat, 
malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell). They do not have 
shortness of breath, dyspnea on exertion, or abnormal imaging. Most patients who are mildly ill can be 
managed in an ambulatory setting or at home through telemedicine or telephone visits. No imaging or 
specific laboratory evaluations are routinely indicated in otherwise healthy patients with mild COVID-19. 
Older patients and those with underlying comorbidities are at higher risk of disease progression; 
therefore, health care providers should monitor these patients closely until clinical recovery is achieved.  
Moderate Illness 
Moderate illness is defined as evidence of lower respiratory disease during clinical assessment or 
imaging, with SpO2 ≥ 94% on room air at sea level. Given that pulmonary disease can progress rapidly in 
patients with COVID-19, patients with moderate disease should be closely monitored. If bacterial 
pneumonia is suspected, administer empiric antibiotic treatment, re-evaluate the patient daily, and 
de-escalate or stop antibiotics if further testing indicates the patient does not have a bacterial infection. 
Severe Illness 
Patients with COVID-19 are considered to have severe illness if they have SpO2 < 94% on room air at sea 
level, PaO2/FiO2 < 300 mm Hg, a respiratory rate > 30 breaths/min, or lung infiltrates > 50%. These 
patients may experience rapid clinical deterioration. Oxygen therapy should be administered immediately 
using a nasal cannula or a high-flow oxygen device. If bacterial pneumonia or sepsis is suspected, 
administer empiric antibiotics, re-evaluate the patient daily, and de-escalate or stop antibiotics if further 
testing indicates the patient does not have a bacterial infection. 
Critical Illness 
SARS-CoV-2 infection can cause acute respiratory distress syndrome, virus-induced distributive (septic) 
shock, cardiac shock, an exaggerated inflammatory response, thrombotic disease, and exacerbation of 
underlying comorbidities. 
Successful clinical management of a patient with COVID-19, as with any patient in the intensive care unit 
(ICU), includes treating both the medical condition that initially resulted in ICU admission as well as 
other comorbidities and nosocomial complications.  
 
Source: NIH 2022