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 (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.

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 ≥ 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.

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, Greece, India, Japan, Mauritius, Mexico, Poland, Puerto Rico, 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.

Northridge, California

Status

Recruiting

Address

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

Northridge, California, 91324

Site Contact

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