Phase 1b/2 Study of IV Sarilumab in Adult With RA
Public ClinicalTrials.gov record NCT07704580. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07704580
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2, 2026 (Actual)
- Primary completion
- Oct 26, 2028 (Estimated)
- Completion
- Oct 26, 2028 (Estimated)
- Last update posted
- Oct 13, 2026
2026 – 2028
United States locations
- U.S. sites
- 12
- U.S. states
- 4
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Veros Health- Site Number : 8400017 | Centennial | Colorado | 80112 | Recruiting |
| Clinical Research of West Florida - Phase I Unit- Site Number : 8400014 | Clearwater | Florida | 33765 | Recruiting |
| Sweet Hope Research Specialty- Site Number : 8400023 | Hialeah | Florida | 33016 | Recruiting |
| Encore Medical Research - Hollywood- Site Number : 8400010 | Hollywood | Florida | 33024 | Recruiting |
| Rheumwell Comprehensive Rheumatology- Site Number : 8400019 | Miami | Florida | 33143 | Recruiting |
| Integral Rheumatology and Immunology Specialists- Site Number : 8400018 | Plantation | Florida | 33324 | Recruiting |
| Encore Medical Research - Weston- Site Number : 8400011 | Weston | Florida | 33331 | 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 |
| Prolato Clinical Research Center- Site Number : 8400006 | Houston | Texas | 77054 | Recruiting |
| Southwest Rheumatology Research- Site Number : 8400004 | Mesquite | Texas | 75150 | Recruiting |
| ClinRx Research - Plano- Site Number : 8400015 | Plano | Texas | 75023 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07704580, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07704580 live on ClinicalTrials.gov.