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

NCT ID: NCT06073093

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2025-07-02

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.

Detailed Description

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SAR441566 dose regimen A

Participant will receive dose regimen A of SAR441566 for 12 weeks

Group Type: EXPERIMENTAL

SAR441566

Intervention Type: DRUG

Tablet

SAR441566 dose regimen B

Participant will receive dose regimen B of SAR441566 for 12 weeks

Group Type: EXPERIMENTAL

SAR441566

Intervention Type: DRUG

Tablet

SAR441566 dose regimen C

Participant will receive dose regimen C of SAR441566 for 12 weeks

Group Type: EXPERIMENTAL

SAR441566

Intervention Type: DRUG

Tablet

SAR441566 dose regimen D

Participant will receive dose regimen D of SAR441566 for 12 weeks

Group Type: EXPERIMENTAL

SAR441566

Intervention Type: DRUG

Tablet

Placebo

Participant will receive SAR441566-matching placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet

Interventions

SAR441566

Tablet

Intervention Type: DRUG

Placebo

Tablet

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Northridge, California, United States

Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004

Upland, California, United States

UF Health Deerwood Park- Site Number : 8400020

Jacksonville, Florida, United States

Life Clinical Trials- Site Number : 8400028

Margate, Florida, United States

Future Care Solution - Miami- Site Number : 8400019

Miami, Florida, United States

Innovia Research Center, Inc- Site Number : 8400026

Miramar, Florida, United States

Integral Rheumatology and Immunology Specialists- Site Number : 8400010

Plantation, Florida, United States

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

Tampa, Florida, United States

Inspire Santa Fe Medical Group- Site Number : 8400029

Santa Fe, New Mexico, United States

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

Charlotte, North Carolina, United States

Carolina Specialty Care- Site Number : 8400007

Statesville, North Carolina, United States

Altoona Center for Clinical Research- Site Number : 8400002

Duncansville, Pennsylvania, United States

Low Country Rheumatology- Site Number : 8400018

Summerville, South Carolina, United States

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

Rapid City, South Dakota, United States

Prolato Clinical Research Center- Site Number : 8400021

Houston, Texas, United States

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

Irving, Texas, United States

Perceptive Pharma Research- Site Number : 8400009

Richmond, Texas, United States

Investigational Site Number : 0320005

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320001

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320003

Buenos Aires, , Argentina

Investigational Site Number : 0320007

Buenos Aires, , Argentina

Investigational Site Number : 0320006

Mar del Plata, , Argentina

Investigational Site Number : 0320002

San Miguel de Tucumán, , Argentina

Investigational Site Number : 0320002

San Miguel de Tucumán, , Argentina

Centro Mineiro de Pesquisa- Site Number : 0760003

Juiz de Fora, Minas Gerais, Brazil

Centro de Estudos em Terapias Inovadoras- Site Number : 0760004

Curitiba, Paraná, Brazil

Hospital São Lucas Copacabana- Site Number : 0760007

Rio de Janeiro, , Brazil

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

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

Investigational Site Number : 1240006

Calgary, Alberta, Canada

Investigational Site Number : 1240001

Brampton, Ontario, Canada

Investigational Site Number : 1240004

Windsor, Ontario, Canada

Investigational Site Number : 1240002

Sherbrooke, Quebec, Canada

Investigational Site Number : 1520001

La Serena, Coquimbo Region, Chile

Investigational Site Number : 1520003

Osorno, Los Lagos Region, Chile

Investigational Site Number : 1520005

Valdivia, Los Ríos Region, Chile

Investigational Site Number : 1520002

Talca, Maule Region, Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520007

Viña del Mar, Región de Valparaíso, Chile

Investigational Site Number : 1520009

Santiago, , Chile

Investigational Site Number : 1560004

Chengdu, , China

Investigational Site Number : 1560003

Hefei, , China

Investigational Site Number : 1560001

Shanghai, , China

Investigational Site Number : 2030006

Brno, , Czechia

Investigational Site Number : 2030002

Ostrava, , Czechia

Investigational Site Number : 2030008

Pardubice, , Czechia

Investigational Site Number : 2030001

Prague, , Czechia

Investigational Site Number : 2030003

Uherské Hradiště, , Czechia

Investigational Site Number : 2680001

Tbilisi, , Georgia

Investigational Site Number : 2760002

Berlin, , Germany

Investigational Site Number : 2760001

Hamburg, , Germany

Investigational Site Number : 2760003

Ratingen, , Germany

Investigational Site Number : 3000001

Athens, , Greece

Investigational Site Number : 3000002

Heraklion, , Greece

Investigational Site Number : 3000003

Thessaloniki, , Greece

Investigational Site Number : 3560006

Ahmedabad, , India

Investigational Site Number : 3560002

Bengaluru, , India

Investigational Site Number : 3560001

Chennai, , India

Investigational Site Number : 3560010

Hyderabad, , India

Investigational Site Number : 3560007

Kolkata, , India

Investigational Site Number : 3560011

Nashik, , India

Investigational Site Number : 3560005

Surat, , India

Investigational Site Number : 3920005

Nagoya, Aichi-ken, Japan

Investigational Site Number : 3920007

Kamogawa, Chiba, Japan

Investigational Site Number : 3920006

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920009

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920004

Kawachi-Nagano, Osaka, Japan

Investigational Site Number : 3920003

Toyonaka, Osaka, Japan

Investigational Site Number : 3920002

Fuchū, Tokyo, Japan

Investigational Site Number : 3920008

Nagasaki, , Japan

Investigational Site Number : 3920011

Tokorozawa, , Japan

Investigational Site Number : 3920001

Toyota, , Japan

Investigational Site Number : 4800001

Vacoas, , Mauritius

Investigational Site Number : 4840002

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840001

Chihuahua City, , Mexico

Investigational Site Number : 4840003

Mérida, , Mexico

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160001

Lublin, Lubusz Voivodeship, Poland

Investigational Site Number : 6160002

Lublin, Lubusz Voivodeship, Poland

Investigational Site Number : 6160003

Bialystok, Podlaskie Voivodeship, Poland

Investigational Site Number : 6160005

Bytom, Silesian Voivodeship, Poland

Investigational Site Number : 6160006

Grodzisk Mazowiecki, , Poland

Caribbean Medical Research Center- Site Number : 8400027

San Juan, , Puerto Rico

Investigational Site Number : 7030003

Nové Mesto nad Váhom, , Slovakia

Investigational Site Number : 7030001

Piešťany, , Slovakia

Investigational Site Number : 7100002

Cape Town, , South Africa

Investigational Site Number : 7100003

Cape Town, , South Africa

Investigational Site Number : 7100001

Pretoria, , South Africa

Investigational Site Number : 7100005

Pretoria, , South Africa

Investigational Site Number : 7100004

Pretoria, , South Africa

Investigational Site Number : 7100007

Stellenbosch, , South Africa

Investigational Site Number : 7240001

A Coruña, A Coruña [La Coruña], Spain

Investigational Site Number : 7240002

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

Investigational Site Number : 7240006

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

Investigational Site Number : 7240005

Seville, Andalusia, Spain

Investigational Site Number : 7240004

Sabadell, Castille and León, Spain

Investigational Site Number : 7240008

Chiclana de la Frontera, , Spain

Investigational Site Number : 7240007

Madrid, , Spain

Investigational Site Number : 7240003

Málaga, , Spain

Countries

United States; Argentina; Brazil; Canada; Chile; China; Czechia; Georgia; Germany; Greece; India; Japan; Mauritius; Mexico; Poland; Puerto Rico; Slovakia; South Africa; Spain

Other Identifiers

U1111-1288-8641

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-503910-60-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

DRI17821

Identifier Type: -

Identifier Source: org_study_id