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Clinical Trials in Japan / NCT05198557
Active, not recruiting Phase 3

A Study of MT-0551 in Patients With Systemic Sclerosis

NCT05198557 · tracked via the Priya Life Science Japan tracker
Sponsor
Tanabe Pharma Corporation
Phase
Phase 3
Started
2022-07-20
Last updated
2025-12-08

Condition(s) studied

Systemic Sclerosis

Investigational drug(s) / intervention(s)

Inebilizumab →Placebo

Inebilizumab: Participants will receive IV inebilizumab.

Placebo: Participants will receive IV placebo matched to inebilizumab.

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: Additional screening criteria check may apply for qualification: 1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied. 2. Skin thickening score based on the mRTSS between 10 and 22 inclusive. Exclusion Criteria: Additional screening criteria check may apply for qualification: 1. Pulmonary hypertension associated with SSc. 2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia. 3. Finding of inadequate respiratory reserve capacity. 4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab. 5. Presence of a clinically significant active infection requiring antimicrobial therapy. 6. A past history of cancer. 7. Past history of a recurrent, clinically significant infection. 8. Past history of severe allergy or anaphylactic reaction to a biologic drug product. 9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

Primary outcome measure(s)

  • Change from baseline in the mRTSS up to the end of the long-term extension period — baseline, RCP 4, 12, 26, OLP 4,12, 26, the long-term extension period 26, 52, 78, 104 weeks

Trial sites (4)

FacilityCityRegionStatus
University of Fukui Hospital Yoshida-gun Fukui
Kanazawa University Hospital Kanazawa Ishikawa-ken
St. Marianna University Hospital Kawasaki-shi Kanagawa
The University of Tokyo Hospital Bunkyo-ku Tokyo

More Tanabe Pharma Corporation trials in Japan

Study of BK1803 in Healthy Infants Starting soon
A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL Active, not recruiting

Other trials for the same condition

A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis Recruiting
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) Active, not recruiting
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05198557 on ClinicalTrials.gov ↗ ← All trials in Japan