MT-0551 treatment for patients with systemic sclerosis

Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)

This study is testing a new treatment called MT-0551 to see if it can help people with systemic sclerosis by reducing skin thickening compared to a placebo over 26 weeks.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Mitsubishi Tanabe Pharma Corporation (industry)
• Drugs / interventions: rituximab, blinatumomab, obinutuzumab, ofatumumab
• Locations: 4 sites (Yoshida-gun, Fukui and 3 other locations)
• Trial ID: NCT05198557 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of MT-0551 compared to a placebo in patients diagnosed with systemic sclerosis over a 26-week period. The primary outcome will be measured using the modified Rodnan Total Skin thickness Score (mRTSS) to assess skin thickening. Additionally, the study will investigate the safety and pharmacokinetics of MT-0551. Eligible participants must meet specific diagnostic criteria and have a certain range of skin thickening scores.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with systemic sclerosis who have a modified Rodnan Total Skin thickness Score between 10 and 22.

Not a fit: Patients with pulmonary hypertension associated with systemic sclerosis or those with serious concurrent illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin symptoms and overall quality of life for patients with systemic sclerosis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating systemic sclerosis with novel therapies.

Eligibility criteria

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).

Where this trial is running

Yoshida-gun, Fukui and 3 other locations

• University of Fukui Hospital — Yoshida-gun, Fukui, Japan (RECRUITING)
• Kanazawa University Hospital — Kanazawa, Ishikawa, Japan (RECRUITING)
• St. Marianna University Hospital — Kawasaki-shi, Kanagawa, Japan (RECRUITING)
• The University of Tokyo Hospital — Bunkyo-ku, Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials, to prevent miscommunication,

Conditions: Systemic Sclerosis