A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (SPECIFI-RA)

STUDY OVERVIEW

This Phase 2, randomized, double-blind, placebo-controlled, 5-arm, international study by Sanofi will evaluate the efficacy and safety of SAR441566 over 12 weeks in adults with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and naive to biologic/targeted synthetic DMARDs.

STUDY GOALS

The goal of this Phase 2 study is to evaluate the efficacy and safety of SAR441566 over 12 weeks in adults with moderate-to-severe rheumatoid arthritis not adequately controlled on methotrexate and naive to biologic/targeted synthetic DMARDs.

LOCATION

El Paso, Texas: Texas Arthritis Center

INCLUSION CRITERIA

  • Diagnosis of adult-onset RA per ACR/EULAR 2010 criteria for at least 3 months and symptoms for at least 6 months.

  • Moderate-to-severe active RA with ≥ 6 tender and swollen joints and high sensitivity C-reactive protein > 5 mg/L.

  • Continuous MTX treatment (10-25 mg/week, 6-16 mg/week in Japan) for at least 12 weeks before randomization and stable dose for at least 6 weeks prior to screening.

  • Inadequate response to MTX at 10-25 mg/week after proper dose escalation.

  • BMI between 18 and 35 kg/m².

exclusion criteria

  • Immunologic disorders other than RA, except secondary Sjogren's syndrome and controlled diabetes or thyroid disorders.

  • Any condition requiring glucocorticoid therapy.

  • Uncontrolled polymyalgia rheumatica or fibromyalgia.

  • Recent or recurrent serious infections, hospitalization, or treatment with IV anti-infectives within 30 days prior to Day 1, or oral anti-infectives within 14 days prior.

  • Significant immunosuppression history or invasive/recurrent infections.

  • History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or other high-risk conditions.

  • History of solid organ transplant.

  • History of alcohol or drug abuse within the past 2 years.

  • History of demyelinating diseases.

  • Planned surgery during the treatment period.

  • Steinbrocker class IV functional capacity.

  • Recent live/live-attenuated virus vaccination or planned vaccination during the trial.

  • Non-live vaccine (e.g., COVID-19) within 14 days prior to randomization or planned during the trial.

  • Personal or family history of long QT syndrome.

  • Active or recent malignancy, except treated localized carcinoma in situ or skin cancers.

  • Previous or current biologic therapy or tsDMARDs for RA.

  • Use of oral glucocorticoids >10 mg prednisone/day, or change in dosage within 4 weeks prior to screening.

  • Use of parenteral or intra-articular glucocorticoids within 4 weeks prior to screening.

  • Initiation or dose change of NSAIDs within 1 week prior to screening.

  • Prior use of cDMARDs other than MTX.

(Note: This summary does not include all considerations for trial participation.)

For more information, visit ClinicalTrials.gov.