Recruiting
Phase 1
Phase 2

Sarilumab with csDMARDs

Sponsor:

Sanofi

Code:

NCT07704580

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sarilumab, SAR153191 SC

Sarilumab, SAR153191 IV

Study Details

Brief 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.

Conditions

Rheumatoid Arthritis

Study ID

NCT07704580

Start date

Jul 2, 2026

Status verified date

Oct, 2026

Completion date

Oct 26, 2028

Anticipated

Primary completion date

Oct 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sarilumab 200 mg Q2W SC - Part A

Participants will receive Sarilumab 200 mg Q2W SC on Day 1 every 2 weeks for 24 weeks.

experimental: Sarilumab Dose Level 1 (DL1) IV - Part A

Participants will receive Sarilumab DL1 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.

experimental: Sarilumab Dose Level 2 (DL2) IV - Part A

Participants will receive Sarilumab DL2 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.

experimental: Sarilumab Dose Level 3 (DL3) IV - Part A

Participants will receive Sarilumab DL3 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.

experimental: Sarilumab Dose Level 4 (DL4) IV - Part A

Participants will receive Sarilumab DL4 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.

experimental: Selected Sarilumab IV Dose - Part B

Participants will receive Sarilumab selected dose IV.

Interventions

Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

Sarilumab, SAR153191 IV

Route of administration: intravenous.

Primary outcome measure

  • Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses [ Time Frame: from Baseline up to Week 6 ]
  • Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses [ Time Frame: from Baseline up to Week 6 ]
  • Part B: Assessment of PK parameters of sarilumab in serum: plasma concentration at steady state (Ctrough ss) [ Time Frame: from Baseline up to Week 30 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Veros Health- Site Number : 8400017

Recruiting

Centennial, Colorado, United States, 80112

Clinical Research of West Florida - Phase I Unit- Site Number : 8400014

Recruiting

Clearwater, Florida, United States, 33765

Sweet Hope Research Specialty- Site Number : 8400023

Recruiting

Hialeah, Florida, United States, 33016

Encore Medical Research - Hollywood- Site Number : 8400010

Recruiting

Hollywood, Florida, United States, 33024

Rheumwell Comprehensive Rheumatology- Site Number : 8400019

Recruiting

Miami, Florida, United States, 33143

Integral Rheumatology and Immunology Specialists- Site Number : 8400018

Recruiting

Plantation, Florida, United States, 33324

Encore Medical Research - Weston- Site Number : 8400011

Recruiting

Weston, Florida, United States, 33331

Altoona Center for Clinical Research - Duncansville- Site Number : 8400007

Recruiting

Duncansville, Pennsylvania, United States, 16635

Texas Arthritis Center- Site Number : 8400021

Recruiting

El Paso, Texas, United States, 79902

Prolato Clinical Research Center- Site Number : 8400006

Recruiting

Houston, Texas, United States, 77054

Southwest Rheumatology Research- Site Number : 8400004

Recruiting

Mesquite, Texas, United States, 75150

ClinRx Research - Plano- Site Number : 8400015

Recruiting

Plano, Texas, United States, 75023

More Information

Sponsor

Sanofi

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.