Overview

Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis

Status:
Not yet recruiting

Trial end date:
2026-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mitsubishi Tanabe Pharma Corporation

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).