A study to evaluate SAR441566 efficacy and safety in adults with rheumatoid arthritis

Phase 2

Recruiting

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-jRCT2041230128
• Lead Sponsor: Tanaka Tomoyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Diagnosis of adult-onset rheumatoid arthritis (RA) classified by American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (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 (CRP) > 5 mg/L
- Continuous treatment with methotrexate (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).
- Body mass index (BMI) within the range [18 - 35] kg/m^2 (inclusive)

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- 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, intramuscular (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 Day 1. Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to Day 1.
- 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 (New York Heart Association [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 Janus Kinase [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

Study & Design

• Study Type: Interventional
• Study Design: Not specified