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Rheumatoid ArthritisBones and jointsDrugPhase 1, Phase 2

What this study is

This is a Phase 1/Phase 2 study with:

  • 5-arms design for Part A;
  • and a single arm for Part B.

The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.

Study details include:

  • The study duration will be up to 64 weeks.
  • The treatment duration will be up to 6 months for each study phase.
  • Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.
  • For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits.
  • For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit.
  • Part B has 13 visits, including a post-treatment EOS follow-up visit.

What's being tested

  • Sarilumab, SAR153191 SC

    Intervention · DRUG

    Pharmaceutical form: solution for injection. Route of administration: subcutaneous.

  • Sarilumab, SAR153191 IV

    Intervention · DRUG

    Route of administration: intravenous.

Study details

Official title
A Randomized Open Label, Phase 1b/2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis
Sponsor
Sanofi
Conditions
Rheumatoid Arthritis
Enrolling
140 people
Starts
2026-07-02
Est. completion
2028-10-26
Design
Open-label, randomized, sequential groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗