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

NCT ID
NCT07704580
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Sanofi
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 140 participants (Estimated).

What is being studied

  • Intervention: sarilumab
  • Drug: Sarilumab, SAR153191 IV
  • Drug: Sarilumab, SAR153191 SC

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 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.

Study locations

4 study locations are listed.

Recruiting site status is explicitly provided for 4 locations; 4 are listed as Recruiting.

Countries: United States

  • Florida, United States: 2
  • Pennsylvania, United States: 1
  • Texas, United States: 1

Sample of listed locations

  • Encore Medical Research - Hollywood- Site Number : 8400010 — Hollywood, Florida, 33024, United States — Recruiting
  • Encore Medical Research - Weston- Site Number : 8400011 — Weston, Florida, 33331, United States — Recruiting
  • Altoona Center for Clinical Research - Duncansville- Site Number : 8400007 — Duncansville, Pennsylvania, 16635, United States — Recruiting
  • ClinRx Research - Plano- Site Number : 8400015 — Plano, Texas, 75023, United States — Recruiting

Study details

Start date
July 2, 2026
Primary completion date
October 26, 2028
Completion date
October 26, 2028
First posted
July 15, 2026
Collaborators
Regeneron Pharmaceuticals

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07704580
Registry last updated
August 11, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07704580 on ClinicalTrials.gov

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