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

Phase 2
Recruiting
Conditions
Rheumatoid Arthritis
Interventions
Drug: SAR441566
Drug: Placebo
Registration Number
NCT06073093
Lead Sponsor
Sanofi
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
240
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)

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SAR441566 dose regimen CSAR441566Participant will receive dose regimen C of SAR441566 for 12 weeks
SAR441566 dose regimen BSAR441566Participant will receive dose regimen B of SAR441566 for 12 weeks
SAR441566 dose regimen ASAR441566Participant will receive dose regimen A of SAR441566 for 12 weeks
SAR441566 dose regimen DSAR441566Participant will receive dose regimen D of SAR441566 for 12 weeks
PlaceboPlaceboParticipant will receive SAR441566-matching placebo for 12 weeks
Primary Outcome Measures
NameTimeMethod
Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12Baseline 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.

Secondary Outcome Measures
NameTimeMethod
Change from baseline in Disease activity score - C-reactive protein (DAS-28 CRP) at week 12Baseline 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.

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

Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)Baseline to week 14

Incidence of TEAEs, SAEs, and AESIs

Plasma pre-dose concentrations of SAR441566Week 2 to week 12
Plasma post-dose concentrations of SAR441566Week 0 to week 12

Trial Locations

Locations (92)

Investigational Site Number : 2760002

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Berlin, Germany

Investigational Site Number : 2760001

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Hamburg, Germany

Investigational Site Number : 2760003

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Ratingen, Germany

Investigational Site Number : 3000001

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Athens, Greece

Investigational Site Number : 3000002

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Heraklion, Greece

Investigational Site Number : 3000003

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Thessaloniki, Greece

Investigational Site Number : 3560006

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Ahmedabad, India

Investigational Site Number : 3560002

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Bangalore, India

Investigational Site Number : 3560001

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Chennai, India

Investigational Site Number : 3560010

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Hyderabad, India

Investigational Site Number : 3560007

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Kolkata, India

Investigational Site Number : 3560011

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Nashik, India

Investigational Site Number : 3560005

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Surat, India

Investigational Site Number : 3920005

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Nagoya, Aichi, Japan

Amicis Research Center- Site Number : 8400023

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Northridge, California, United States

Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004

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Upland, California, United States

UF Health Rheumatology- Deerwood Park- Site Number : 8400020

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Jacksonville, Florida, United States

Life Clinical Trials- Site Number : 8400028

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Margate, Florida, United States

Future Care Solution - Miami- Site Number : 8400019

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Miami, Florida, United States

Innovia Research Center, Inc- Site Number : 8400026

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Miramar, Florida, United States

Integral Rheumatology and Immunology Specialists- Site Number : 8400010

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Plantation, Florida, United States

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

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Tampa, Florida, United States

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

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Charlotte, North Carolina, United States

Carolina Specialty Care- Site Number : 8400007

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Statesville, North Carolina, United States

Altoona Center for Clinical Research- Site Number : 8400002

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Duncansville, Pennsylvania, United States

Low Country Rheumatology- Site Number : 8400018

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Summerville, South Carolina, United States

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

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Rapid City, South Dakota, United States

Prolato Clinical Research Center- Site Number : 8400021

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Houston, Texas, United States

Perceptive Pharma Research- Site Number : 8400009

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Richmond, Texas, United States

Investigational Site Number : 0320005

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Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320004

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Buenos Aires, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 0320001

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Buenos Aires, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 0320003

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Buenos Aires, Argentina

Investigational Site Number : 0320007

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Buenos Aires, Argentina

Investigational Site Number : 0320006

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Mar Del Plata, Argentina

Investigational Site Number : 0320002

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San Miguel de Tucumán, Argentina

Centro Mineiro de Pesquisa- Site Number : 0760003

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Juiz de Fora, Minas Gerais, Brazil

Centro de Estudos em Terapias Inovadoras- Site Number : 0760004

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Curitiba, Paraná, Brazil

Hospital São Lucas Copacabana- Site Number : 0760007

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Rio de Janeiro, Brazil

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

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Rio de Janeiro, Brazil

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

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São Paulo, Brazil

Investigational Site Number : 1240001

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Brampton, Ontario, Canada

Investigational Site Number : 1240004

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Windsor, Ontario, Canada

Investigational Site Number : 1520001

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La Serena, Coquimbo, Chile

Investigational Site Number : 1520003

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Osorno, Los Lagos, Chile

Investigational Site Number : 1520005

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Valdivia, Los Ríos, Chile

Investigational Site Number : 1520002

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Talca, Maule, Chile

Investigational Site Number : 1520004

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520006

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520008

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520007

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Viña Del Mar, Valparaíso, Chile

Investigational Site Number : 1520009

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Santiago, Chile

Investigational Site Number : 1560004

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Chengdu, China

Investigational Site Number : 1560003

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Hefei, China

Investigational Site Number : 1560001

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Shanghai, China

Investigational Site Number : 2030006

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Brno, Czechia

Investigational Site Number : 2030002

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Ostrava, Czechia

Investigational Site Number : 2030001

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Prague, Czechia

Investigational Site Number : 2030003

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Uherské Hradiště, Czechia

Investigational Site Number : 2680001

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Tbilisi, Georgia

Investigational Site Number : 3920007

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Kamogawa, Chiba, Japan

Investigational Site Number : 3920006

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Sapporo, Hokkaido, Japan

Investigational Site Number : 3920009

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Sapporo, Hokkaido, Japan

Investigational Site Number : 3920004

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Kawachinagano, Osaka, Japan

Investigational Site Number : 3920003

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Toyonaka, Osaka, Japan

Investigational Site Number : 3920002

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Fuchu, Tokyo, Japan

Investigational Site Number : 3920008

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Nagasaki, Japan

Investigational Site Number : 3920001

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Toyota, Japan

Investigational Site Number : 4800001

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Vacoas-phoenix, Mauritius

Investigational Site Number : 4840002

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Mexico City, Ciudad De Mexico, Mexico

Investigational Site Number : 4840001

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Chihuahua, Mexico

Investigational Site Number : 4840003

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Mérida, Mexico

Investigational Site Number : 6160001

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Lublin, Lubuskie, Poland

Investigational Site Number : 6160002

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Lublin, Lubuskie, Poland

Investigational Site Number : 6160003

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Bialystok, Podlaskie, Poland

Investigational Site Number : 6160005

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Bytom, Slaskie, Poland

Investigational Site Number : 6160004

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Poznan, Wielkopolskie, Poland

Investigational Site Number : 6160006

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Grodzisk Mazowiecki, Poland

Investigational Site Number : 7030003

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Nové Mesto Nad Váhom, Slovakia

Investigational Site Number : 7030001

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Piešťany, Slovakia

Investigational Site Number : 7100002

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Cape Town, South Africa

Investigational Site Number : 7100003

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Cape Town, South Africa

Investigational Site Number : 7100001

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Pretoria, South Africa

Investigational Site Number : 7100005

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Pretoria, South Africa

Investigational Site Number : 7100004

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Pretoria, South Africa

Investigational Site Number : 7240001

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A Coruña, A Coruña [La Coruña], Spain

Investigational Site Number : 7240002

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

Investigational Site Number : 7240005

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Seville, Andalucia, Spain

Investigational Site Number : 7240004

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Sabadell, Castilla Y León, Spain

Investigational Site Number : 7240008

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Chiclana de La Frontera, Spain

Investigational Site Number : 7240007

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Madrid, Spain

Investigational Site Number : 7240003

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Málaga, Spain

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