Rheumatoid ArthritisPhase 1/2OPALSNCT07704580
Phase 1b/2 Study of IV Sarilumab in Adult With RA
A Phase 1/2 study testing Sarilumab, SAR153191 SC and Sarilumab, SAR153191 IV in people with Rheumatoid Arthritis, run by Sanofi at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Sarilumab, SAR153191 SC and Sarilumab, SAR153191 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 12 sitesUnited States
- Study dates
- 2 Jul 2026to 26 Oct 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Veros Health- Site Number : 8400017
Centennial, Colorado, 80112
- Recruiting
Clinical Research of West Florida - Phase I Unit- Site Number : 8400014
Clearwater, Florida, 33765
- Recruiting
Altoona Center for Clinical Research - Duncansville- Site Number : 8400007
Duncansville, Pennsylvania, 16635
- Recruiting
Texas Arthritis Center- Site Number : 8400021
El Paso, Texas, 79902
- Recruiting
Sweet Hope Research Specialty- Site Number : 8400023
Hialeah, Florida, 33016
- Recruiting
Encore Medical Research - Hollywood- Site Number : 8400010
Hollywood, Florida, 33024
- Recruiting
Prolato Clinical Research Center- Site Number : 8400006
Houston, Texas, 77054
- Recruiting
Southwest Rheumatology Research- Site Number : 8400004
Mesquite, Texas, 75150
- Recruiting
Rheumwell Comprehensive Rheumatology- Site Number : 8400019
Miami, Florida, 33143
- Recruiting
ClinRx Research - Plano- Site Number : 8400015
Plano, Texas, 75023
- Recruiting
Integral Rheumatology and Immunology Specialists- Site Number : 8400018
Plantation, Florida, 33324
- Recruiting
Encore Medical Research - Weston- Site Number : 8400011
Weston, Florida, 33331
About this study
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
This is a Phase 1/Phase 2 study with:
- 5-arms design for Part A;
- and a single arm for Part B.
Read more
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
- Being tested
- Sarilumab, SAR153191 SC, Sarilumab, SAR153191 IV
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarilumab, SAR153191 SCDrug
Also called Kevzara®
Pharmaceutical form:
solution for injection.
Route of administration: subcutaneous.
Sarilumab, SAR153191 IVDrug
Route of administration: intravenous.
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab 200 mg Q2W SC - Part A | Active comparator | Participants will receive Sarilumab 200 mg Q2W SC on Day 1 every 2 weeks for 24 weeks. Receives: Drug: Sarilumab, SAR153191 SC |
| Sarilumab Dose Level 1 (DL1) IV - Part A | Experimental | 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. Receives: Drug: Sarilumab, SAR153191 SC; Drug: Sarilumab, SAR153191 IV |
| Sarilumab Dose Level 2 (DL2) IV - Part A | Experimental | 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. Receives: Drug: Sarilumab, SAR153191 SC; Drug: Sarilumab, SAR153191 IV |
| Sarilumab Dose Level 3 (DL3) IV - Part A | Experimental | 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. Receives: Drug: Sarilumab, SAR153191 SC; Drug: Sarilumab, SAR153191 IV |
| Sarilumab Dose Level 4 (DL4) IV - Part A | Experimental | 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. Receives: Drug: Sarilumab, SAR153191 SC; Drug: Sarilumab, SAR153191 IV |
| Selected Sarilumab IV Dose - Part B | Experimental | Participants will receive Sarilumab selected dose IV. Receives: Drug: Sarilumab, SAR153191 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
Area under the concentration versus time curve from time zero to time corresponding to the last measurable concentration, tlast.
Measured: from Baseline up to Week 6
Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses
Maximum concentration observed.
Measured: from Baseline up to Week 6
Part B: Assessment of PK parameters of sarilumab in serum: plasma concentration at steady state (Ctrough ss)
Concentration observed before treatment administration during repeated dosing at steady state.
Measured: from Baseline up to Week 30
Secondary outcomes (8)
Part A: Proportion of participants who experienced adverse events (AEs): treatment-emergent adverse events (TEAEs) up to the post-treatment EOS follow-up visit included
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) are defined as AEs that developed, worsened or became serious during the treatment-emergent period.
Measured: From Baseline up to Week 32
Part A: Proportion of participants who experienced potentially clinically significant abnormalities (PCSA) in clinical laboratory evaluations, vital signs, and electrocardiogram (ECG) parameters
For laboratory variables (hematology, clinical biochemistry, urinalysis, serology and coagulation variables), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.
For vital signs (heart rate, systolic and diastolic blood pressure, and temperature) and ECG variables (heart rate, PR, QRS, QT and QTcF intervals), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.
Measured: From Baseline up to Week 32
Part A: Proportion of participants with injection site reactions (local tolerability assessments)
Measured: From Baseline up to Week 26
Part B: Assessment of PK parameters of sarilumab in serum: maximum peak plasma drug concentration at steady state (Cmax ss)
Maximum concentration observed at steady state.
Measured: from Baseline up to Week 30
Part B: Area under the curve for the defined interval between doses (TAU) at steady state (AUC0-tau ss)
Area under the concentration versus time curve calculated using the trapezoidal method during a dose interval (τ) at steady state.
Measured: from Baseline up to Week 30
Part B: Proportion of participants who experienced adverse events (AEs): treatment-emergent adverse events (TEAEs) up to the post-treatment EOS follow-up visit included
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) are defined as AEs that developed, worsened or became serious during the treatment-emergent period.
Measured: From Baseline up to Week 30
Part B: Proportion of participants who experienced potentially clinically significant abnormalities (PCSA) in clinical laboratory test evaluations, vital signs, and electrocardiogram (ECG) parameters
For laboratory variables (hematology, clinical biochemistry, urinalysis, serology and coagulation variables), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.
For vital signs (heart rate, systolic and diastolic blood pressure, and temperature) and ECG variables (heart rate, PR, QRS, QT and QTcF intervals), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.
Measured: From Baseline up to Week 30
Part B: Proportion of participants with injection site reactions (local tolerability assessments)
Measured: From Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start2 Jul 2026
- Primary completion26 Oct 2028 (estimated)
- Study completion26 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704580
- Sponsor's protocol ID
- DRI19694
- Other IDs
- U1111-1337-1202
- Acronym
- OPALS
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org