Phase 1b/2 Study of IV Sarilumab in Adult With RA (NCT07704580) | Clinical Trial Compass
RecruitingPhase 1/2
Phase 1b/2 Study of IV Sarilumab in Adult With RA
United States140 participantsStarted 2026-07-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
* Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.
* ACR Class I to III functional status, based on the 1991 revised criteria
* Moderate-to-severely active RA, defined as: DAS28-ESR\>3.2.
* Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
* Any prior (within the defined periods below) or concurrent use of immunosuppressive:
* Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.
* Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
* Anakinra within 1 week of baseline.
* Abatacept within 8 weeks of baseline.
* Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.
* Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.
* Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
* Therapeutic failure, including inadequate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
Timeframe: from Baseline up to Week 6
2
Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses
Timeframe: from Baseline up to Week 6
3
Part B: Assessment of PK parameters of sarilumab in serum: plasma concentration at steady state (Ctrough ss)
Timeframe: from Baseline up to Week 30
Trial details
NCT IDNCT07704580
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-10-26
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)