Trials / Active Not Recruiting
Active Not RecruitingNCT05987423
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Satralizumab | Satralizumab will be administered by SC injection. |
| DRUG | Placebo | Placebo will be administered by SC injection |
Timeline
- Start date
- 2023-10-26
- Primary completion
- 2025-07-08
- Completion
- 2026-07-01
- First posted
- 2023-08-14
- Last updated
- 2026-02-03
Locations
46 sites across 10 countries: United States, Argentina, Australia, Austria, Germany, Hong Kong, Hungary, Italy, Japan, Singapore
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05987423. Inclusion in this directory is not an endorsement.