A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (SPECIFI-RA)

July 10, 2025 updated by: Sanofi

A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety Study of SAR441566 Plus Methotrexate in Adults With ModeratetoSevere Rheumatoid Arthritis

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 rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive.

Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX.

Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall study duration for each participant will be approximately up to 149 days.

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1121
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentina, 1221
        • Investigational Site Number : 0320007
      • Mar Del Plata, Argentina, 7600
        • Investigational Site Number : 0320006
      • San Miguel de Tucuman, Argentina, T4000AXL
        • Investigational Site Number : 0320002
      • San Miguel de Tucumán, Argentina, 4000
        • Investigational Site Number : 0320002
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1886
        • Investigational Site Number : 0320005
    • Ciudad De Buenos Aires
      • Buenos Aires, Ciudad De Buenos Aires, Argentina, 1114
        • Investigational Site Number : 0320004
      • Buenos Aires, Ciudad De Buenos Aires, Argentina, 1430
        • Investigational Site Number : 0320001
  • Brazil
      • Rio de Janeiro, Brazil, 22061-080
        • Hospital São Lucas Copacabana- Site Number : 0760007
      • Rio de Janeiro, Brazil, 22241-180
        • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760005
      • São Paulo, Brazil, 04265-000
        • Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760001
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Centro Mineiro de Pesquisa- Site Number : 0760003
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Centro de Estudos em Terapias Inovadoras- Site Number : 0760004
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
        • Investigational Site Number : 1240006
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Investigational Site Number : 1240001
      • Windsor, Ontario, Canada, N8X 1T3
        • Investigational Site Number : 1240004
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Investigational Site Number : 1240002
  • Chile
      • Santiago, Chile, 8330032
        • Investigational Site Number : 1520009
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Investigational Site Number : 1520001
    • Los Lagos
      • Osorno, Los Lagos, Chile, 5311092
        • Investigational Site Number : 1520003
    • Los Ríos
      • Valdivia, Los Ríos, Chile, 5110683
        • Investigational Site Number : 1520005
    • Maule
      • Talca, Maule, Chile, 3465584
        • Investigational Site Number : 1520002
    • Reg Metropolitana De Santiago
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500587
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500505
        • Investigational Site Number : 1520004
      • Santiago, Reg Metropolitana De Santiago, Chile, 8320325
        • Investigational Site Number : 1520008
    • Valparaíso
      • Viña Del Mar, Valparaíso, Chile, 2520598
        • Investigational Site Number : 1520007
  • China
      • Chengdu, China, 610041
        • Investigational Site Number : 1560004
      • Hefei, China, 230001
        • Investigational Site Number : 1560003
      • Shanghai, China, 200040
        • Investigational Site Number : 1560001
  • Czechia
      • Brno, Czechia, 638 00
        • Investigational Site Number : 2030006
      • Ostrava, Czechia, 702 00
        • Investigational Site Number : 2030002
      • Pardubice, Czechia, 530 02
        • Investigational Site Number : 2030008
      • Prague, Czechia, 128 00
        • Investigational Site Number : 2030001
      • Uherské Hradiště, Czechia, 686 01
        • Investigational Site Number : 2030003
  • Georgia
      • Tbilisi, Georgia, 0112
        • Investigational Site Number : 2680001
  • Germany
      • Berlin, Germany, 12161
        • Investigational Site Number : 2760002
      • Hamburg, Germany, 20095
        • Investigational Site Number : 2760001
      • Ratingen, Germany, 40882
        • Investigational Site Number : 2760003
  • Greece
      • Athens, Greece, 124 62
        • Investigational Site Number : 3000001
      • Heraklion, Greece, 711 10
        • Investigational Site Number : 3000002
      • Thessaloniki, Greece, 546 36
        • Investigational Site Number : 3000003
  • India
      • Ahmedabad, India, 380016
        • Investigational Site Number : 3560006
      • Bengaluru, India, 560079
        • Investigational Site Number : 3560002
      • Chennai, India, 600004
        • Investigational Site Number : 3560001
      • Hyderabad, India, 500072
        • Investigational Site Number : 3560010
      • Kolkata, India, 700020
        • Investigational Site Number : 3560007
      • Nashik, India, 422101
        • Investigational Site Number : 3560011
      • Surat, India, 395002
        • Investigational Site Number : 3560005
  • Japan
      • Nagasaki, Japan, 850-0832
        • Investigational Site Number : 3920008
      • Tokorozawa, Japan, 359-1111
        • Investigational Site Number : 3920011
      • Toyota, Japan, 470-0396
        • Investigational Site Number : 3920001
    • Aichi
      • Nagoya, Aichi, Japan, 457-8511
        • Investigational Site Number : 3920005
    • Chiba
      • Kamogawa, Chiba, Japan, 296-0041
        • Investigational Site Number : 3920007
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0001
        • Investigational Site Number : 3920006
      • Sapporo, Hokkaido, Japan, 063-0811
        • Investigational Site Number : 3920009
    • Osaka
      • Kawachinagano, Osaka, Japan, 586-0008
        • Investigational Site Number : 3920004
      • Toyonaka, Osaka, Japan, 560-8552
        • Investigational Site Number : 3920003
    • Tokyo
      • Fuchu, Tokyo, Japan, 183-8524
        • Investigational Site Number : 3920002
  • Mauritius
      • Vacoas-phoenix, Mauritius, 72218
        • Investigational Site Number : 4800001
  • Mexico
      • Chihuahua, Mexico, 31210
        • Investigational Site Number : 4840001
      • Mérida, Mexico, 97070
        • Investigational Site Number : 4840003
    • Ciudad De Mexico
      • Mexico City, Ciudad De Mexico, Mexico, 06700
        • Investigational Site Number : 4840002
  • Poland
      • Grodzisk Mazowiecki, Poland, 05-825
        • Investigational Site Number : 6160006
    • Lubuskie
      • Lublin, Lubuskie, Poland, 20-363
        • Investigational Site Number : 6160001
      • Lublin, Lubuskie, Poland, 20-607
        • Investigational Site Number : 6160002
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-879
        • Investigational Site Number : 6160003
    • Slaskie
      • Bytom, Slaskie, Poland, 41-902
        • Investigational Site Number : 6160005
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-397
        • Investigational Site Number : 6160004
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Caribbean Medical Research Center- Site Number : 8400027
  • Slovakia
      • Nové Mesto Nad Váhom, Slovakia, 915 01
        • Investigational Site Number : 7030003
      • Piešťany, Slovakia, 921 01
        • Investigational Site Number : 7030001
  • South Africa
      • Cape Town, South Africa, 7405
        • Investigational Site Number : 7100002
      • Cape Town, South Africa, 7500
        • Investigational Site Number : 7100003
      • Pretoria, South Africa, 0002
        • Investigational Site Number : 7100001
      • Pretoria, South Africa, 0002
        • Investigational Site Number : 7100005
      • Pretoria, South Africa, 0184
        • Investigational Site Number : 7100004
      • Stellenbosch, South Africa, 7600
        • Investigational Site Number : 7100007
  • Spain
      • Chiclana de La Frontera, Spain, 11139
        • Investigational Site Number : 7240008
      • Madrid, Spain, 28003
        • Investigational Site Number : 7240007
      • Málaga, Spain, 29010
        • Investigational Site Number : 7240003
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Investigational Site Number : 7240001
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
        • Investigational Site Number : 7240002
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15705
        • Investigational Site Number : 7240006
    • Andalucia
      • Seville, Andalucia, Spain, 41010
        • Investigational Site Number : 7240005
    • Castilla Y León
      • Sabadell, Castilla Y León, Spain, 08208
        • Investigational Site Number : 7240004
  • United States
    • California
      • Northridge, California, United States, 91324
        • Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400023
      • Upland, California, United States, 91786
        • Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004
    • Florida
      • Jacksonville, Florida, United States, 32256
        • UF Health Deerwood Park- Site Number : 8400020
      • Margate, Florida, United States, 33063
        • Life Clinical Trials- Site Number : 8400028
      • Miami, Florida, United States, 33142
        • Future Care Solution - Miami- Site Number : 8400019
      • Miramar, Florida, United States, 33027
        • Innovia Research Center, Inc- Site Number : 8400026
      • Plantation, Florida, United States, 33324
        • Integral Rheumatology and Immunology Specialists- Site Number : 8400010
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8400017
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Inspire Santa Fe Medical Group- Site Number : 8400029
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400012
      • Statesville, North Carolina, United States, 28625
        • Carolina Specialty Care- Site Number : 8400007
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research- Site Number : 8400002
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Low Country Rheumatology- Site Number : 8400018
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • American Indian Clinical Trials Research Network - Rapid City- Site Number : 8400022
    • Texas
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center- Site Number : 8400021
      • Irving, Texas, United States, 75039
        • AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400031
      • Richmond, Texas, United States, 77407
        • Perceptive Pharma Research- Site Number : 8400009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration

  • Moderate-to-severely active RA, defined as:

    • persistently active disease >= 6 tender and >= 6 swollen joints
    • high sensitivity C-reactive protein ≥ 4 mg/L

  • 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) and folic/folinic acid (as part of MTX regimen)
  • Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards
  • BMI within the range [18 - 35] kg/m^2 (inclusive)

Exclusion Criteria:

  • Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgement
  • Any condition (other than RA) requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy
  • Uncontrolled polymyalgia rheumatica or fibromyalgia
  • 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 anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
  • 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
  • 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
  • History of solid organ transplant
  • History of alcohol or drug abuse within the past 2 years

  • History of diagnosis of demyelinating disease such as but not limited to:

    • Multiple Sclerosis
    • Acute Disseminated Encephalomyelitis
    • Balo's Disease (Concentric Sclerosis)
    • Charcot-Marie-Tooth Disease
    • Guillain-Barre Syndrome
    • human T-lymphotropic virus 1 Associated Myelopathy
    • Neuromyelitis Optica (Devic's Disease)
  • Planned surgery during the treatment period
  • Participants who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
  • Vaccination with live or live-attenuated virus vaccine within 3 months prior to screening or plan to receive one during the trial including at least 3 months after the last dose of study drug
  • Any non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trial
  • Participant with personal or family history of long QT syndrome
  • Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin
  • Previous or current use of biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD - such as JAK inhibitors) for RA
  • Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to screening. The dose of oral glucocorticoid must remain stable.
  • Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening
  • Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR441566 dose regimen A
Participant will receive dose regimen A of SAR441566 for 12 weeks
Drug: SAR441566
Tablet
Experimental: SAR441566 dose regimen B
Participant will receive dose regimen B of SAR441566 for 12 weeks
Drug: SAR441566
Tablet
Experimental: SAR441566 dose regimen C
Participant will receive dose regimen C of SAR441566 for 12 weeks
Drug: SAR441566
Tablet
Experimental: SAR441566 dose regimen D
Participant will receive dose regimen D of SAR441566 for 12 weeks
Drug: SAR441566
Tablet
Placebo Comparator: Placebo
Participant will receive SAR441566-matching placebo for 12 weeks
Drug: Placebo
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12
Time Frame: Baseline to Week 12
ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and acute phase reactants (ESR or CRP mg/dl; in this study CRP will be used). ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR20 is ≥ 20% improvement.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma pre-dose concentrations of SAR441566
Time Frame: Week 2 to week 12
Week 2 to week 12
Plasma post-dose concentrations of SAR441566
Time Frame: Week 0 to week 12
Week 0 to week 12
Change from baseline in Disease activity score - C-reactive protein (DAS-28 CRP) at week 12
Time Frame: Baseline to Week 12

The DAS28-CRP is a composite endpoint. DAS28-CRP is comprised of clinical assessment of 28 swollen joint count (SJC)/ tender joint count (TJC), patient assessment of global disease activity and CRP mg/dL. It is a continuous measure allowing for measurement of absolute change in disease burden and percentage improvement.

The DAS28 can be calculated using the following formula:

DAS28 = 0.56 x 28TJC + 0.28 x 28SJC + 0.36 x Log(CRP+1) + 0.014 x GH + 0.96 The DAS28 provides a number indicating the current activity of the RA. A DAS28 above 5.1 means high disease activity, whereas a DAS28 below 3.2 indicates low disease activity and a DAS28 below 2.6 means disease remission.
Baseline to Week 12
Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12
Time Frame: Baseline to week 12
ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR50 is ≥ 50% improvement. ACR50 responders include ACR20 responders
Baseline to week 12
Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Time Frame: Baseline to week 14
Incidence of TEAEs, SAEs, and AESIs
Baseline to week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI17821 (Sanofi Identifier)
  • 2023-503910-60-00 (Registry Identifier: CTIS)
  • U1111-1288-8641 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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