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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sarilumab, SAR153191 SC — DRUG
  Pharmaceutical form: solution for injection. Route of administration: subcutaneous.
• Sarilumab, SAR153191 IV — DRUG
  Route of administration: intravenous.

Study Details

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.

Key Dates

First listed

Jul 15, 2026

Start date

Jul 2, 2026

Status verified

Jul 2026

Primary completion

Oct 26, 2028

Completion

Oct 26, 2028

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Sarilumab 200 mg Q2W SC - Part A
  Participants will receive Sarilumab 200 mg Q2W SC on Day 1 every 2 weeks for 24 weeks.
• Experimental: Sarilumab Dose Level 1 (DL1) IV - Part A
  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.
• Experimental: Sarilumab Dose Level 2 (DL2) IV - Part A
  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.
• Experimental: Sarilumab Dose Level 3 (DL3) IV - Part A
  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.
• Experimental: Sarilumab Dose Level 4 (DL4) IV - Part A
  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.
• Experimental: Selected Sarilumab IV Dose - Part B
  Participants will receive Sarilumab selected dose IV.

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 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (2)

Find similar trials in Hollywood, FL

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