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

NCT07704580 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-08-11

No results posted yet for this study

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

Interventions

DRUG

Sarilumab, SAR153191 SC

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

DRUG

Sarilumab, SAR153191 IV

Route of administration: intravenous.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-02
Primary Completion
2028-10-26
Completion
2028-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704580 on ClinicalTrials.gov