Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07704580 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Phase 1b/2 Study of IV Sarilumab in Adult With RA

Study acronym: OPALS
StatusRecruiting
PhasePhase 1/2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 4 → 12 locations
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 4 of 8 entries
  2. Minor Study sites: 2 to 4v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07704580
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)
Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov