Status:
ACTIVE_NOT_RECRUITING
A Study of MT-0551 in Patients With Systemic Sclerosis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Additional screening criteria check may apply for qualification:
- Pulmonary hypertension associated with SSc.
- Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
- Finding of inadequate respiratory reserve capacity.
- 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.
- Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05198557
Start Date
July 20 2022
End Date
August 1 2026
Last Update
December 8 2025
Active Locations (4)
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1
University of Fukui Hospital
Yoshida-gun, Fukui, Japan, 910-1193
2
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
3
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan, 216-8511
4
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8655