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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of sarilumab given through a vein (IV) and how the body handles it, with or without other RA pills. It is for adults with moderate to severe rheumatoid arthritis (RA), a disease that causes joint swelling and pain.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, or meet the local legal age for giving consent.
  • Have RA diagnosed using standard medical rules for at least 3 months.
  • Have moderate to severe active RA, based on a disease activity score.
  • Meet study rules for ability to do daily activities (ACR Class I, II, or III).
  • Be unable to continue a standard first-choice RA drug because it did not work well enough or caused side effects.
  • Follow local rules for birth control during clinical studies.

Who can't join

  • Use certain drugs that weaken the immune system now or too recently. Required waiting times range from 1 week to 6 months; some drugs also require recovery of immune cells.
  • Have had an IL-6 blocker, a type of RA drug, fail or cause side effects, or have a medical reason not to use one. Stopping one for other reasons at least 3 months earlier does not rule you out.
  • Take a changing dose of methotrexate, or take more than 10 mg a day of steroids that act throughout the body.
  • Be pregnant or breastfeeding.
  • Have active or incompletely treated tuberculosis (TB), a past serious infection linked to weak immune defenses, or a past infection in a natural or artificial joint.
  • Have uncontrolled diabetes or certain cancers within the past 5 years. Some fully treated early cervical cancers and skin cancers that have not spread are allowed.
  • Have inflammatory bowel disease, severe swelling of pouches in the bowel (diverticulitis), or a past hole in the stomach or bowel.
  • Have arthritis that began before age 16, juvenile idiopathic arthritis, or severe RA that affects other parts of the body, such as blood vessels or lungs.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (12)

CO

FL

PA

TX