A Study of MT-0551 in Patients With Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198557
• Other study ID #: MT-0551-A-301
• Status: Recruiting
• Phase: Phase 3
• Start date: July 20, 2022
• Est. completion date: July 2026

Study information

• Verified date: September 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: Clinical Trials, to prevent miscommunication,
• Phone: please e-mail
• Email: cti-inq-ml[@]ml.mt-pharma.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Inebilizumab
Participants will receive IV inebilizumab.
• Placebo
Participants will receive IV placebo matched to inebilizumab.

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	St. Marianna University Hospital	Kawasaki-shi	Kanagawa
Japan	University of Fukui Hospital	Yoshida-gun	Fukui

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the mRTSS at Week 26		Baseline and Week 26
Secondary	Pulmonary function tests: Change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco)		Baseline to at least 52 weeks or early termination
Secondary	Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco		Baseline to at least 52 weeks or early termination
Secondary	Change from baseline in the mRTSS		Baseline to at least 52 weeks or early termination
Secondary	Composite response index in diffuse cutaneous systemic sclerosis		Week 26 to at least 52 weeks or early termination