Trials / Active Not Recruiting
Active Not RecruitingNCT05198557
A Study of MT-0551 in Patients With Systemic Sclerosis
Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Tanabe Pharma Corporation · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study will verify the superiority of MT-0551 to placebo at 26 weeks after treatment initiation in systemic sclerosis (SSc) patients using the modified Rodnan Total Skin thickness Score (mRTSS) as a measure of skin thickening. The safety and pharmacokinetics will also be investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inebilizumab | Participants will receive IV inebilizumab. |
| DRUG | Placebo | Participants will receive IV placebo matched to inebilizumab. |
Timeline
- Start date
- 2022-07-20
- Primary completion
- 2025-07-31
- Completion
- 2026-08-01
- First posted
- 2022-01-20
- Last updated
- 2025-12-08
Locations
4 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05198557. Inclusion in this directory is not an endorsement.