Clinical trial NCT05198557: A Study of MT-0551 in Patients With Systemic Sclerosis
Official title: Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Systemic Sclerosis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 outcomes:
measure: Change from baseline in the mRTSS up to the end of the long-term extension period
timeFrame: baseline, RCP 4, 12, 26, OLP 4,12, 26, the long-term extension period 26, 52, 78, 104 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline to at least 52 weeks or early termination
measure: Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco
timeFrame: Baseline to at least 52 weeks or early termination
measure: Change from baseline in the mRTSS
timeFrame: Baseline to at least 52 weeks or early termination
measure: Composite response index in diffuse cutaneous systemic sclerosis
timeFrame: Week 26 to at least 52 weeks or early termination
Other outcomes:
Locations:
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: