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 ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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 response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
- Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).
- Concurrent use of systemic corticosteroids (CS) of more than 10 mg/day.
- Pregnant or breastfeeding woman.
- Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.
- History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).
- Uncontrolled diabetes mellitus.
- History of prior articular or prosthetic joint infection.
- Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.
- History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
- History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
- Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (12)
12 openVeros Health- Site Number : 8400017
Centennial, Colorado, United States
RecruitingClinical Research of West Florida - Phase I Unit- Site Number : 8400014
Clearwater, Florida, United States
RecruitingSweet Hope Research Specialty- Site Number : 8400023
Hialeah, Florida, United States
RecruitingEncore Medical Research - Hollywood- Site Number : 8400010
Hollywood, Florida, United States
RecruitingRheumwell Comprehensive Rheumatology- Site Number : 8400019
Miami, Florida, United States
RecruitingIntegral Rheumatology and Immunology Specialists- Site Number : 8400018
Plantation, Florida, United States
RecruitingEncore Medical Research - Weston- Site Number : 8400011
Weston, Florida, United States
RecruitingAltoona Center for Clinical Research - Duncansville- Site Number : 8400007
Duncansville, Pennsylvania, United States
RecruitingTexas Arthritis Center- Site Number : 8400021
El Paso, Texas, United States
RecruitingProlato Clinical Research Center- Site Number : 8400006
Houston, Texas, United States
RecruitingSouthwest Rheumatology Research- Site Number : 8400004
Mesquite, Texas, United States
RecruitingClinRx Research - Plano- Site Number : 8400015
Plano, Texas, United States
Recruiting
Study team
Sponsor
Sanofi
Study ID DRI19694
CONTACT
Trial Transparency email recommended (Toll free for US & Canada)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.