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CTRI Number  CTRI/2024/05/067017 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to calculate efficacy and safety of SAR441566 in adults with rheumatoid arthritis 
Scientific Title of Study   A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety study of SAR441566 plus Methotrexate in Adults with Moderate-to-Severe Rheumatoid Arthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2023-503910-60  EudraCT 
DRI17821 Version 1 Dated 28 Jun 2023  Protocol Number 
NCT06073093  ClinicalTrials.gov 
U1111-1288-8641   Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Kumar Jeyaprakash 
Designation  Medical Advisor 
Affiliation  Sanofi India Private Limited (SIL) 
Address  Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki Vihar Road, Powai

Mumbai
MAHARASHTRA
400072
India 
Phone  9790753835  
Fax    
Email  dineshkumar.jeyaprakash@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Ms Neha Bhatia 
Designation  Clinical Project Leader 
Affiliation  Sanofi India Limited (SIL) 
Address  Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki Vihar Road, Powai, Mumbai
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki Vihar Road, Powai
Mumbai
MAHARASHTRA
400 072
India 
Phone  9769755202  
Fax    
Email  Neha.Bhatia@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi Healthcare India Pvt Limited, Sanofi House, C.T.S No.117b, L& T Business park, Saki Vihar Road, Powai, Mumbai -400072 
 
Primary Sponsor  
Name  Sanofi Healthcare India Pvt Limited (SHIPL) 
Address  Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, Maharashtra, 400 072, India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
Canada
Chile
Czech Republic
Georgia
Germany
Greece
India
Japan
Mauritius
Mexico
Poland
South Africa
Spain
United States of America
China  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen Pratap Jadhav  Assured Care plus hospital, Nashik  4th & 5th Floor, Star Plus Complex, Lam Road, Near Muktidham Temple Opp. NMC Divisional Office, Nashik Road, Nashik- 422101
Nashik
MAHARASHTRA 		 0253-950011

drpraveenjadhav@rediffmail.com 
Dr Himanshu Panchal  B. J. Medical College and Civil Hospital  B. J. Medical College and Civil Hospital, Department of Orthopedics, 2nd floor, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT 		 9825463696

drhimanshupanchal@gmail.com 
Dr Chandrashekara Shrikantiah  ChanRe Rheumatology & Immunology Center & Research  Department of Rheumatology and Immunology, 3rd floor , Research Unit. No.414/65, 20th Main, West of Chord Road, 1st Block, Rajajinagara, Bangalore-560010
Bangalore
KARNATAKA 		 918042516699

chandrashekara_s@yahoo.com 
Dr Venkataramanan Krishnamoorthy  Chennai Meenakshi multispecialty hospital  Chennai Meenakshi multispecialty hospital, Department of Rheumatology, Ground Floor,No-148, Luz church road, Mylapore, Chennai-600004
Chennai
TAMIL NADU 		 9841041717

drvk56@gmail.com 
Dr Uppuluri Ramakrishna Rao  Gleneagles Global Hospital  Clinical Research Room, 5th Floor, 6-1-1070/1 to 4, Lakdi-ka-pool, Hyderabad-500004 Telangana
Hyderabad
TELANGANA 		 9849160640

urkrao@yahoo.com 
Dr Parasar Ghosh  IPGMER and SSKM Hospital  Dept. of Clinical Immunology & Rheumatology, 5th Floor, 244 A.J.C. Bose Road Kolkata 700020
Kolkata
WEST BENGAL 		 9433988317

drparasar@gmail.com 
Dr Nishil Shah  Nirmal Hospital Private Limited  Ring Road, Department of Rheumatology, 3rd floor, Surat, Gujurat-395002
Surat
GUJARAT 		 9099925983

arnish002@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
CMMHEC, Chennai Meenakshi Multispeciality Hospital Limited  Submittted/Under Review 
IEC, Assured Care Plus hospital, Nashik  Approved 
Institutional Ethics Committee – CRICR, ChanRe Rheumatology Immunology Center Research  Submittted/Under Review 
Institutional Ethics Committee B.J. Medical College and Civil Hospital  Submittted/Under Review 
Institutional Ethics Committee Gleneagles Global Hospitals  Submittted/Under Review 
IPGMEandR Research Oversight Committee IPGMEandR,  Submittted/Under Review 
NIRMAL HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M068||Other specified rheumatoid arthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MTX  According to local recommendation in the country where the study is conducted. 
Intervention  SAR441566 100 mg or SAR441566 50 mg  For each dose arm, the participant will take 2 tablets in the morning and 2 in the evening (4 tablets total per day). Duration of IMP treatment is 12 weeks 
Comparator Agent  SAR441566 matching placebo  For each dose arm, the participant will take 2 tablets in the morning and 2 in the evening (4 tablets total per day).Duration of IMP treatment is 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. At least 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent.
2. Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA (28) of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration.
3. Moderate-to-severely active RA, defined as:
-- Persistently active disease more than equal to 6 tender and more than equal to 6 swollen joints.
-- High sensitivity C-reactive protein more than 5 mg/L.
4. Participants who stopped biologic treatment due to non-response, partial response, loss of efficacy (e.g., failure to achieve or maintain remission (IGA 0, clear skin to 2, mild disease)) must have been previously treated with biologic (at labelled dose level) for at least 4 months, as confirmed by investigator judgment.
5. Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit.
--MTX – 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs, eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) and folic/folinic acid (as part of MTX regimen).
6. BMI within the range (18 - 35) kg/m2 (inclusive).
7. All contraceptive methods used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
8. Male participants Male participants are eligible to participate if they agree to the following during the study treatment period and for at least 3 months after the last administration of study IMP: - Refrain from donating or cryopreserving sperm; PLUS, either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR - Must agree to use contraception as detailed below: A male condom and an additional highly effective contraceptive method (as described in Section 10.4), when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
9. Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:- Is a woman of nonchildbearing potential (WONCBP) as defined in the protocol; OR - Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of less than 1percent per year), preferably with low user dependency (as described in Section 10.4) during the study intervention period (to be effective before starting the intervention) and for at least 3 months after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations%2 
 
ExclusionCriteria 
Details  1. Immunologic disorder other than RA, with the exception of secondary Sjogrens syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigators judgement.
2. Any condition requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy.
3. Uncontrolled polymyalgia rheumatica or fibromyalgia
4. History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
5. Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
6. History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.
7. History of solid organ transplant. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Response to ACR20 (proportion of participants
achieving at least 20% improvement from baseline
in the ACR score) at Week 12 		 at Week 12
 
 
Secondary Outcome  
Outcome  TimePoints 
- To assess the efficacy of SAR441566, with respect to placebo, plus MTX, on change from baseline to week 12 in DAS28-CRP and response to ACR50 in the treatment of RA
- To evaluate the safety and tolerability of SAR441566
- To assess PK of SAR441566 in participants with RA
- Change from baseline in DAS28-CRP at Week 12
- Response to ACR50 (proportion of participants achieving at least 50% improvement from baseline in the ACR score) at Week 12
- Incidence of TEAEs, SAEs, and AESIs
- Incidence of study IMP permanent discontinuations and study withdrawals due to TEAEs
- Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
- Plasma pre-dose and post-dose concentrations of SAR441566 		 at week 12 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe RA not adequately controlled on MTX and biologic/targeted synthetic DMARD naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include: • Run-in period (6 weeks ±3 days), with blood draw (2 weeks ±3 days) before randomization to determine eligibility. Treatment period (12 weeks ±3 days). • Post-treatment period (safety follow-up) (2 weeks ±3 days). • The total number of scheduled study visits will be 8. At least 6 weeks prior to screening, participants must be using a stable dose of MTX, between 10-25 mg (or per local labelling requirements for the treatment of RA if dose range differs). They must continue this stable dose during run-in and throughout the study. Participants who satisfy the inclusion and exclusion criteria will be randomized (2:2:1:1:2 ratio) to either SAR441566 (200 mg BID, 200 mg QD, 100 mg QD, 50 mg QD) or matching placebo, administered orally BID on top of MTX for 12 weeks. Visits during the 12-week treatment period will occur at week 0 (baseline/randomization), 2, 4, 8 and 12. Followed by a 2-week post-treatment period (safety follow-up). 
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