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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.
Show all 21Show fewer
  • 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

800-633-1610 ext. option 6

Contact-US@sanofi.com

12 sites in 1 country

United States12 sites, 12 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

    Recruiting

Other trials in United States

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.
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 groups in NCT07704580
Study groupRoleWhat they receive
Sarilumab 200 mg Q2W SC - Part AActive comparatorParticipants 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 AExperimentalParticipants 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 AExperimentalParticipants 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 AExperimentalParticipants 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 AExperimentalParticipants 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 BExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. Part A: Proportion of participants with injection site reactions (local tolerability assessments)

    Measured: From Baseline up to Week 26

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted15 Jul 2026
  2. Study start2 Jul 2026
  3. Primary completion26 Oct 2028 (estimated)
  4. Study completion26 Oct 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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