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

NCT07704580 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: DRI19694U1111-1337-1202
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  From Baseline up to Week 32

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

  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)

  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)

  from Baseline up to Week 30

Study Arms (6)

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.

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.

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.

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.

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.

Drug: Sarilumab, SAR153191 SC; Drug: Sarilumab, SAR153191 IV

Selected Sarilumab IV Dose - Part B

EXPERIMENTAL

Participants will receive Sarilumab selected dose IV.

Drug: Sarilumab, SAR153191 IV

Interventions

Sarilumab, SAR153191 SC DRUG

Pharmaceutical form: solution for injection. Route of administration: subcutaneous.

Also known as: Kevzara®

Sarilumab 200 mg Q2W SC - Part A; Sarilumab Dose Level 1 (DL1) IV - Part A; Sarilumab Dose Level 2 (DL2) IV - Part A; Sarilumab Dose Level 3 (DL3) IV - Part A; Sarilumab Dose Level 4 (DL4) IV - Part A

Sarilumab, SAR153191 IV DRUG

Route of administration: intravenous.

Sarilumab Dose Level 1 (DL1) IV - Part A; Sarilumab Dose Level 2 (DL2) IV - Part A; Sarilumab Dose Level 3 (DL3) IV - Part A; Sarilumab Dose Level 4 (DL4) IV - Part A; Selected Sarilumab IV Dose - Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Encore Medical Research - Hollywood- Site Number : 8400010

Hollywood, Florida, 33024, United States

RECRUITING

ClinRx Research - Plano- Site Number : 8400015

Plano, Texas, 75023, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 15, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): October 26, 2028
• Study Completion (Estimated): October 26, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)