NCT07704580 · Sanofi
Phase 1b/2 Study of IV Sarilumab in Adult With RA
(OPALS)
What this study is about
This is a Phase 1/Phase 2 study with: * 5-treatment group$1 design for Part A; * and a single treatment group$1 for Part B.
View original scientific description
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.
Interventions
DRUG
Sarilumab, SAR153191 SC
Pharmaceutical form: solution for injection. Route of administration: subcutaneous.
DRUG
Sarilumab, SAR153191 IV
Route of administration: intravenous.
Primary outcome measures
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
Area under the concentration versus time curve from time zero to time corresponding to the last measurable concentration, tlast.
Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses
Time frame: from Baseline up to Week 6
Maximum concentration observed.
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
Concentration observed before treatment administration during repeated dosing at steady state.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
Where
- Hollywood, Florida
- Plano, Texas
Collaborators
Regeneron Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations