A Study of MT-0551 in Patients With Systemic Sclerosis

Last updated: July 3, 2024
Sponsor: Mitsubishi Tanabe Pharma Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Scar Tissue

Scleroderma

Collagen Vascular Diseases

Treatment

Placebo

Inebilizumab

Clinical Study ID

NCT05198557
MT-0551-A-301
  • Ages 20-80
  • All Genders

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 Criteria

Inclusion

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

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 interstitialpneumonia.

  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 antimicrobialtherapy.

  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 isacceptable).

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 20, 2022
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • University of Fukui Hospital

    Yoshida-gun, Fukui 910-1193
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo 113-8655
    Japan

    Active - Recruiting

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