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Phase 1b/2 Study of IV Sarilumab in Adult With RA
Sponsor: Sanofi
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-07-02
Completion Date
2028-10-26
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Interventions
Sarilumab, SAR153191 SC
Pharmaceutical form: solution for injection. Route of administration: subcutaneous.
Sarilumab, SAR153191 IV
Route of administration: intravenous.
Locations (2)
Encore Medical Research - Hollywood- Site Number : 8400010
Hollywood, Florida, United States
ClinRx Research - Plano- Site Number : 8400015
Plano, Texas, United States