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

Study Purpose

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 (6 weeks ± 3 days) 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 > 5 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, eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) 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 (eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) - 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 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 6 weeks prior to randomization or plan to receive one during the trial.
  • - 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.
  • - Prior use of conventional disease-modifying anti-rheumatic drugs (cDMARDs) other than MTX.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06073093
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Brazil, Canada, Chile, China, Czechia, Georgia, Germany, Japan, Mauritius, Mexico, Poland, Slovakia, South Africa, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

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

Arms & Interventions

Arms

Experimental: SAR441566 dose regimen A

Participant will receive dose regimen A of SAR441566 for 12 weeks

Experimental: SAR441566 dose regimen B

Participant will receive dose regimen B of SAR441566 for 12 weeks

Experimental: SAR441566 dose regimen C

Participant will receive dose regimen C of SAR441566 for 12 weeks

Experimental: SAR441566 dose regimen D

Participant will receive dose regimen D of SAR441566 for 12 weeks

Placebo Comparator: Placebo

Participant will receive SAR441566-matching placebo for 12 weeks

Interventions

Drug: - SAR441566

Tablet

Drug: - Placebo

Tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Upland, California

Status

Recruiting

Address

Inland Rheumatology Clinical Trials, Inc. Site Number : 8400004

Upland, California, 91786

Miami, Florida

Status

Recruiting

Address

Future Care Solutions, LLC Site Number : 8400019

Miami, Florida, 33165

Iris Rheumatology Site Number : 8400010, Plantation, Florida

Status

Recruiting

Address

Iris Rheumatology Site Number : 8400010

Plantation, Florida, 33324

Tampa, Florida

Status

Recruiting

Address

Clinical Research of West Florida, Inc Site Number : 8400017

Tampa, Florida, 33606

Zephyrhills, Florida

Status

Recruiting

Address

Florida Medical Clinic, LLC Site Number : 8400014

Zephyrhills, Florida, 33542

Charlotte, North Carolina

Status

Recruiting

Address

Arthritis and Osteoporosis Consultants of the Carolinas Site Number : 8400012

Charlotte, North Carolina, 28207

Charlotte, North Carolina

Status

Recruiting

Address

DJL Clinical Research, PLLC Site Number : 8400007

Charlotte, North Carolina, 28211

Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research Site Number : 8400002

Duncansville, Pennsylvania, 16635

El Paso, Texas

Status

Recruiting

Address

Texas Arthritis Center Site Number : 8400015

El Paso, Texas, 79902

Houston, Texas

Status

Recruiting

Address

Prolato Clinical Research Center Site Number : 8400021

Houston, Texas, 77054

Plano, Texas

Status

Recruiting

Address

Trinity Universal Research Associates Site Number : 8400008

Plano, Texas, 75042

Richmond, Texas

Status

Recruiting

Address

Perceptive Pharma Research Site Number : 8400009

Richmond, Texas, 77407

International Sites

Investigational Site Number : 0320001, Caba, Ciudad De Buenos Aires, Argentina

Status

Recruiting

Address

Investigational Site Number : 0320001

Caba, Ciudad De Buenos Aires, C1430EGF

Investigational Site Number : 0320004, Ciudad de Buenos Aires, Argentina

Status

Recruiting

Address

Investigational Site Number : 0320004

Ciudad de Buenos Aires, , 1027

Investigational Site Number : 0320006, Mar del Plata, Argentina

Status

Recruiting

Address

Investigational Site Number : 0320006

Mar del Plata, , B7600FYK

Investigational Site Number : 0320002, San Miguel de Tucuman, Argentina

Status

Recruiting

Address

Investigational Site Number : 0320002

San Miguel de Tucuman, , T4000AXL

Juiz de Fora, Minas Gerais, Brazil

Status

Recruiting

Address

CMIP - Centro Mineiro de Pesquisa Site Number : 0760003

Juiz de Fora, Minas Gerais, 36010-570

Curitiba, Paraná, Brazil

Status

Recruiting

Address

CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760004

Curitiba, Paraná, 80060-240

Rio de Janeiro, Brazil

Status

Recruiting

Address

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760005

Rio de Janeiro, , 20241-180

São Paulo, Brazil

Status

Recruiting

Address

CEPIC Centro Paulista de Investigação LTDA Site Number : 0760001

São Paulo, , 04266-010

Investigational Site Number : 1240001, Brampton, Ontario, Canada

Status

Recruiting

Address

Investigational Site Number : 1240001

Brampton, Ontario, L6T 0G1

Investigational Site Number : 1520001, La Serena, Coquimbo, Chile

Status

Recruiting

Address

Investigational Site Number : 1520001

La Serena, Coquimbo, 1720430

Investigational Site Number : 1520003, Osorno, Los Lagos, Chile

Status

Recruiting

Address

Investigational Site Number : 1520003

Osorno, Los Lagos, 5311092

Investigational Site Number : 1520005, Valdivia, Los Ríos, Chile

Status

Recruiting

Address

Investigational Site Number : 1520005

Valdivia, Los Ríos, 5110683

Investigational Site Number : 1520002, Talca, Maule, Chile

Status

Recruiting

Address

Investigational Site Number : 1520002

Talca, Maule,

Investigational Site Number : 1520004, Santiago, Reg Metropolitana De Santiago, Chile

Status

Recruiting

Address

Investigational Site Number : 1520004

Santiago, Reg Metropolitana De Santiago, 7500504

Investigational Site Number : 1520006, Santiago, Reg Metropolitana De Santiago, Chile

Status

Recruiting

Address

Investigational Site Number : 1520006

Santiago, Reg Metropolitana De Santiago, 7500587

Investigational Site Number : 1520008, Santiago, Reg Metropolitana De Santiago, Chile

Status

Recruiting

Address

Investigational Site Number : 1520008

Santiago, Reg Metropolitana De Santiago, 7650568

Investigational Site Number : 1520007, Viña del Mar, Valparaíso, Chile

Status

Recruiting

Address

Investigational Site Number : 1520007

Viña del Mar, Valparaíso, 2520598

Investigational Site Number : 1520009, Santiago de Chile, Chile

Status

Recruiting

Address

Investigational Site Number : 1520009

Santiago de Chile, ,

Investigational Site Number : 1560004, Chengdu, China

Status

Recruiting

Address

Investigational Site Number : 1560004

Chengdu, , 610041

Investigational Site Number : 1560001, Shanghai, China

Status

Recruiting

Address

Investigational Site Number : 1560001

Shanghai, , 200040

Investigational Site Number : 2030006, Brno-Sever, Czechia

Status

Recruiting

Address

Investigational Site Number : 2030006

Brno-Sever, , 638 00

Investigational Site Number : 2030002, Ostrava, Czechia

Status

Recruiting

Address

Investigational Site Number : 2030002

Ostrava, , 702 00

Investigational Site Number : 2030001, Praha 2, Czechia

Status

Recruiting

Address

Investigational Site Number : 2030001

Praha 2, , 12850

Investigational Site Number : 2030003, Uherske Hradiste, Czechia

Status

Recruiting

Address

Investigational Site Number : 2030003

Uherske Hradiste, , 686 01

Investigational Site Number : 2680001, Tbilisi, Georgia

Status

Recruiting

Address

Investigational Site Number : 2680001

Tbilisi, , 0112

Investigational Site Number : 2760002, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number : 2760002

Berlin, , 12161

Investigational Site Number : 2760001, Hamburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760001

Hamburg, , 20095

Investigational Site Number : 2760003, Ratingen, Germany

Status

Recruiting

Address

Investigational Site Number : 2760003

Ratingen, , 40878

Investigational Site Number : 3920005, Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920005

Nagoya-shi, Aichi, 457-8511

Investigational Site Number : 3920007, Kamogawa-shi, Chiba, Japan

Status

Recruiting

Address

Investigational Site Number : 3920007

Kamogawa-shi, Chiba, 296-0041

Investigational Site Number : 3920006, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Investigational Site Number : 3920006

Sapporo-shi, Hokkaido, 060-0001

Investigational Site Number : 3920008, Nagasaki-shi, Nagasaki, Japan

Status

Recruiting

Address

Investigational Site Number : 3920008

Nagasaki-shi, Nagasaki, 850-0832

Investigational Site Number : 3920004, Kawachinagano-shi, Osaka, Japan

Status

Recruiting

Address

Investigational Site Number : 3920004

Kawachinagano-shi, Osaka, 586-8521

Investigational Site Number : 3920003, Toyonaka-shi, Osaka, Japan

Status

Recruiting

Address

Investigational Site Number : 3920003

Toyonaka-shi, Osaka, 560-8552

Investigational Site Number : 3920002, Fuchu-shi, Tokyo, Japan

Status

Recruiting

Address

Investigational Site Number : 3920002

Fuchu-shi, Tokyo, 183-8524

Investigational Site Number : 3920001, Toyota-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920001

Toyota-shi, , 470-0396

Investigational Site Number : 4800001, Quatre Bornes, Mauritius

Status

Recruiting

Address

Investigational Site Number : 4800001

Quatre Bornes, , 72218

Investigational Site Number : 4840001, Chihuahua, Mexico

Status

Recruiting

Address

Investigational Site Number : 4840001

Chihuahua, , 31203

Investigational Site Number : 4840002, Mexico, Mexico

Status

Recruiting

Address

Investigational Site Number : 4840002

Mexico, , 06700

Investigational Site Number : 6160001, Lublin, Lubuskie, Poland

Status

Recruiting

Address

Investigational Site Number : 6160001

Lublin, Lubuskie, 20-362

Investigational Site Number : 6160002, Lublin, Lubuskie, Poland

Status

Recruiting

Address

Investigational Site Number : 6160002

Lublin, Lubuskie, 20-607

Investigational Site Number : 6160003, Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Investigational Site Number : 6160003

Bialystok, Podlaskie, 15-879

Investigational Site Number : 6160005, Bytom, Slaskie, Poland

Status

Recruiting

Address

Investigational Site Number : 6160005

Bytom, Slaskie, 41-902

Investigational Site Number : 6160004, Poznan, Wielkopolskie, Poland

Status

Recruiting

Address

Investigational Site Number : 6160004

Poznan, Wielkopolskie, 61-397

Investigational Site Number : 6160006, Grodzisk Mazowiecki, Poland

Status

Recruiting

Address

Investigational Site Number : 6160006

Grodzisk Mazowiecki, , 05-825

Investigational Site Number : 7030003, Nove Mesto Nad Vahom, Slovakia

Status

Recruiting

Address

Investigational Site Number : 7030003

Nove Mesto Nad Vahom, , 915 01

Investigational Site Number : 7030001, Piestany, Slovakia

Status

Recruiting

Address

Investigational Site Number : 7030001

Piestany, , 921 01

Investigational Site Number : 7100002, Cape Town, South Africa

Status

Recruiting

Address

Investigational Site Number : 7100002

Cape Town, , 7405

Investigational Site Number : 7100003, Cape Town, South Africa

Status

Recruiting

Address

Investigational Site Number : 7100003

Cape Town, , 7500

Investigational Site Number : 7100001, Pretoria, South Africa

Status

Recruiting

Address

Investigational Site Number : 7100001

Pretoria, , 0002

Investigational Site Number : 7100005, Pretoria, South Africa

Status

Recruiting

Address

Investigational Site Number : 7100005

Pretoria, , 0002

Investigational Site Number : 7100004, Pretoria, South Africa

Status

Recruiting

Address

Investigational Site Number : 7100004

Pretoria, , 0184

Investigational Site Number : 7240001, La Coruña, A Coruña [La Coruña], Spain

Status

Recruiting

Address

Investigational Site Number : 7240001

La Coruña, A Coruña [La Coruña], 15006

Investigational Site Number : 7240002, Santiago de Compostela, A Coruña [La Coruña], Spain

Status

Recruiting

Address

Investigational Site Number : 7240002

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

Investigational Site Number : 7240005, Sevilla, Andalucia, Spain

Status

Recruiting

Address

Investigational Site Number : 7240005

Sevilla, Andalucia, 41010

Investigational Site Number : 7240004, Barcelona / Sabadell, Castilla Y León, Spain

Status

Recruiting

Address

Investigational Site Number : 7240004

Barcelona / Sabadell, Castilla Y León, 08208

Investigational Site Number : 7240003, Málaga, Spain

Status

Recruiting

Address

Investigational Site Number : 7240003

Málaga, , 29010