NCT05198557Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 6 Jan 2022
- Start date
- 20 Jul 2022
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Tanabe Pharma Corporation
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05198557
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 80
- From 20 Jul 2022 to the primary completion date, 31 Jul 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
- Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
Other illness
- Pulmonary hypertension associated with SSc.
- Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
- Presence of a clinically significant active infection requiring antimicrobial therapy.
- A past history of cancer.
- Past history of a recurrent, clinically significant infection.
- Past history of severe allergy or anaphylactic reaction to a biologic drug product.
Other
- Additional screening criteria check may apply for qualification:
- Finding of inadequate respiratory reserve capacity.
Who the study is looking for
- Additional screening criteria check may apply for qualification:
- ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
- Skin thickening score based on the mRTSS between 10 and 22 inclusive.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| University of Fukui Hospital Coordinator of this site? Confirm its status | Yoshida-gun | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.