A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

NCT06073093 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: DRI17821U1111-1288-86412023-503910-60-00
• Study Type: interventional
• Target: 264
• Locations: 19 countries
• Sites: 102

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 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at 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 Outcomes (5)

• Change from baseline in Disease activity score - C-reactive protein (DAS-28 CRP) at week 12

  Baseline to Week 12

• Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12

  Baseline to week 12

• Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)

  Baseline to week 14

• Plasma pre-dose concentrations of SAR441566

  Week 2 to week 12

• Plasma post-dose concentrations of SAR441566

  Week 0 to week 12

Study Arms (5)

SAR441566 dose regimen A

EXPERIMENTAL

Participant will receive dose regimen A of SAR441566 for 12 weeks

Drug: SAR441566

SAR441566 dose regimen B

EXPERIMENTAL

Participant will receive dose regimen B of SAR441566 for 12 weeks

Drug: SAR441566

SAR441566 dose regimen C

EXPERIMENTAL

Participant will receive dose regimen C of SAR441566 for 12 weeks

Drug: SAR441566

SAR441566 dose regimen D

EXPERIMENTAL

Participant will receive dose regimen D of SAR441566 for 12 weeks

Drug: SAR441566

Placebo

PLACEBO COMPARATOR

Participant will receive SAR441566-matching placebo for 12 weeks

Drug: Placebo

Interventions

SAR441566 DRUG

Tablet

SAR441566 dose regimen A; SAR441566 dose regimen B; SAR441566 dose regimen C; SAR441566 dose regimen D

Placebo DRUG

Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (102)

Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400023

Northridge, California, 91324, United States

Location

Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004

Upland, California, 91786, United States

Location

UF Health Deerwood Park- Site Number : 8400020

Jacksonville, Florida, 32256, United States

Location

Life Clinical Trials- Site Number : 8400028

Margate, Florida, 33063, United States

Location

Future Care Solution - Miami- Site Number : 8400019

Miami, Florida, 33142, United States

Location

Innovia Research Center, Inc- Site Number : 8400026

Miramar, Florida, 33027, United States

Location

Integral Rheumatology and Immunology Specialists- Site Number : 8400010

Plantation, Florida, 33324, United States

Location

Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8400017

Tampa, Florida, 33606, United States

Location

Inspire Santa Fe Medical Group- Site Number : 8400029

Santa Fe, New Mexico, 87505, United States

Location

Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400012

Charlotte, North Carolina, 28207, United States

Location

Carolina Specialty Care- Site Number : 8400007

Statesville, North Carolina, 28625, United States

Location

Altoona Center for Clinical Research- Site Number : 8400002

Duncansville, Pennsylvania, 16635, United States

Location

Low Country Rheumatology- Site Number : 8400018

Summerville, South Carolina, 29486, United States

Location

American Indian Clinical Trials Research Network - Rapid City- Site Number : 8400022

Rapid City, South Dakota, 57701, United States

Location

Prolato Clinical Research Center- Site Number : 8400021

Houston, Texas, 77054, United States

Location

AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400031

Irving, Texas, 75039, United States

Location

Perceptive Pharma Research- Site Number : 8400009

Richmond, Texas, 77407, United States

Location

Investigational Site Number : 0320005

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, Buenos Aires F.D., 1114, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, Buenos Aires F.D., 1430, Argentina

Location

Investigational Site Number : 0320003

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320007

Buenos Aires, 1221, Argentina

Location

Investigational Site Number : 0320006

Mar del Plata, 7600, Argentina

Location

Investigational Site Number : 0320002

San Miguel de Tucumán, 4000, Argentina

Location

Investigational Site Number : 0320002

San Miguel de Tucumán, T4000AXL, Argentina

Location

Centro Mineiro de Pesquisa- Site Number : 0760003

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Centro de Estudos em Terapias Inovadoras- Site Number : 0760004

Curitiba, Paraná, 80030-110, Brazil

Location

Hospital São Lucas Copacabana- Site Number : 0760007

Rio de Janeiro, 22061-080, Brazil

Location

CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760005

Rio de Janeiro, 22241-180, Brazil

Location

Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760001

São Paulo, 04265-000, Brazil

Location

Investigational Site Number : 1240006

Calgary, Alberta, T2N 4L7, Canada

Location

Investigational Site Number : 1240001

Brampton, Ontario, L6T 0G1, Canada

Location

Investigational Site Number : 1240004

Windsor, Ontario, N8X 1T3, Canada

Location

Investigational Site Number : 1240002

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Investigational Site Number : 1520001

La Serena, Coquimbo Region, 1720430, Chile

Location

Investigational Site Number : 1520003

Osorno, Los Lagos Region, 5311092, Chile

Location

Investigational Site Number : 1520005

Valdivia, Los Ríos Region, 5110683, Chile

Location

Investigational Site Number : 1520002

Talca, Maule Region, 3465584, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 7500505, Chile

Location

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, 7500587, Chile

Location

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, 8320325, Chile

Location

Investigational Site Number : 1520007

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Investigational Site Number : 1520009

Santiago, 8330032, Chile

Location

Investigational Site Number : 1560004

Chengdu, 610041, China

Location

Investigational Site Number : 1560003

Hefei, 230001, China

Location

Investigational Site Number : 1560001

Shanghai, 200040, China

Location

Investigational Site Number : 2030006

Brno, 638 00, Czechia

Location

Investigational Site Number : 2030002

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2030008

Pardubice, 530 02, Czechia

Location

Investigational Site Number : 2030001

Prague, 128 00, Czechia

Location

Investigational Site Number : 2030003

Uherské Hradiště, 686 01, Czechia

Location

Investigational Site Number : 2680001

Tbilisi, 0112, Georgia

Location

Investigational Site Number : 2760002

Berlin, 12161, Germany

Location

Investigational Site Number : 2760001

Hamburg, 20095, Germany

Location

Investigational Site Number : 2760003

Ratingen, 40882, Germany

Location

Investigational Site Number : 3000001

Athens, 124 62, Greece

Location

Investigational Site Number : 3000002

Heraklion, 711 10, Greece

Location

Investigational Site Number : 3000003

Thessaloniki, 546 36, Greece

Location

Investigational Site Number : 3560006

Ahmedabad, 380016, India

Location

Investigational Site Number : 3560002

Bengaluru, 560079, India

Location

Investigational Site Number : 3560001

Chennai, 600004, India

Location

Investigational Site Number : 3560010

Hyderabad, 500072, India

Location

Investigational Site Number : 3560007

Kolkata, 700020, India

Location

Investigational Site Number : 3560011

Nashik, 422101, India

Location

Investigational Site Number : 3560005

Surat, 395002, India

Location

Investigational Site Number : 3920005

Nagoya, Aichi-ken, 457-8511, Japan

Location

Investigational Site Number : 3920007

Kamogawa, Chiba, 296-0041, Japan

Location

Investigational Site Number : 3920006

Sapporo, Hokkaido, 060-0001, Japan

Location

Investigational Site Number : 3920009

Sapporo, Hokkaido, 063-0811, Japan

Location

Investigational Site Number : 3920004

Kawachi-Nagano, Osaka, 586-0008, Japan

Location

Investigational Site Number : 3920003

Toyonaka, Osaka, 560-8552, Japan

Location

Investigational Site Number : 3920002

Fuchū, Tokyo, 183-8524, Japan

Location

Investigational Site Number : 3920008

Nagasaki, 850-0832, Japan

Location

Investigational Site Number : 3920011

Tokorozawa, 359-1111, Japan

Location

Investigational Site Number : 3920001

Toyota, 470-0396, Japan

Location

Investigational Site Number : 4800001

Vacoas, 72218, Mauritius

Location

Investigational Site Number : 4840002

Mexico City, Mexico City, 06700, Mexico

Location

Investigational Site Number : 4840001

Chihuahua City, 31210, Mexico

Location

Investigational Site Number : 4840003

Mérida, 97070, Mexico

Location

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship, 61-397, Poland

Location

Investigational Site Number : 6160001

Lublin, Lubusz Voivodeship, 20-363, Poland

Location

Investigational Site Number : 6160002

Lublin, Lubusz Voivodeship, 20-607, Poland

Location

Investigational Site Number : 6160003

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Investigational Site Number : 6160005

Bytom, Silesian Voivodeship, 41-902, Poland

Location

Investigational Site Number : 6160006

Grodzisk Mazowiecki, 05-825, Poland

Location

Caribbean Medical Research Center- Site Number : 8400027

San Juan, 00918, Puerto Rico

Location

Investigational Site Number : 7030003

Nové Mesto nad Váhom, 915 01, Slovakia

Location

Investigational Site Number : 7030001

Piešťany, 921 01, Slovakia

Location

Investigational Site Number : 7100002

Cape Town, 7405, South Africa

Location

Investigational Site Number : 7100003

Cape Town, 7500, South Africa

Location

Investigational Site Number : 7100001

Pretoria, 0002, South Africa

Location

Investigational Site Number : 7100005

Pretoria, 0002, South Africa

Location

Investigational Site Number : 7100004

Pretoria, 0184, South Africa

Location

Investigational Site Number : 7100007

Stellenbosch, 7600, South Africa

Location

Investigational Site Number : 7240001

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Investigational Site Number : 7240002

Santiago de Compostela, A Coruña [La Coruña], 15702, Spain

Location

Investigational Site Number : 7240006

Santiago de Compostela, A Coruña [La Coruña], 15705, Spain

Location

Investigational Site Number : 7240005

Seville, Andalusia, 41010, Spain

Location

Investigational Site Number : 7240004

Sabadell, Castille and León, 08208, Spain

Location

Investigational Site Number : 7240008

Chiclana de la Frontera, 11139, Spain

Location

Investigational Site Number : 7240007

Madrid, 28003, Spain

Location

Investigational Site Number : 7240003

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: November 7, 2023
• Primary Completion: June 18, 2025
• Study Completion: July 2, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); GR (3); MA (1); GE (1); IN (7); BR (5); US (17); CN (3); CA (4); ZA (6); CZ (5); JP (10); SL (2); ME (3); DE (3); AR (8); PL (6); ES (8); CL (9)