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A Study of MT-0551 in Patients With Systemic Sclerosis

StatusActive, Not Recruiting
PhasePhase 3
Started2022-07-20
View on ClinicalTrials.gov ↗

Amendment history

2026-08-06
Active, Not Recruiting→Terminated Study Status, Participant Flow, Outcome Measures (Results) v12
Trial statusActive, Not Recruiting→Terminated
Reason stoppednot stated→The study was terminated due to a sponsor decision.
Completion dateestimated 2026-08→confirmed 2026-07-28
2026-07-01
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v11
Primary completion date2025-07-31→2025-07-30
Enrollment targetestimated 80→confirmed 4
Secondary endpoints4 entries, revised
Pulmonary functionFunction testsTests: Change fromFrom baselineBaseline in the percentPercent predictedPredicted forcedForced vitalVital capacityCapacity (%FVC) and percentPercent predictedPredicted diffusingDiffusing capacityCapacity of the lungLung carbonCarbon monoxideMonoxide (%DLco) Pulmonary functionFunction testsTests: Percentage changeChange fromFrom baselineBaseline in the %FVC and %DLco Change fromFrom baselineBaseline in the mRTSS Composite responseResponse indexIndex in diffuseDiffuse cutaneousCutaneous systemicSystemic sclerosisSclerosis
Primary endpoints1 entry, revised
Change fromFrom baselineBaseline in the mRTSS up to the endEnd of the longLong-term extensionExtension periodPeriod
2025-12-04
Study Status v10
Re-verified, no change to tracked fields
2025-09-05
Study Status v9
Primary completion dateestimated 2025-08→confirmed 2025-07-31
Completion date2027-04→2026-08
2025-06-11
Recruiting→Active, Not Recruiting Study Status, Outcome Measures, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-03→2025-08
Primary endpoints1 entry, revised
Change from baseline in the mRTSS atup Weekto 26the end of the long-term extension period
Study sitesdetails revised at 4 of 4 sites
Show 7 earlier versions
2024-07-03
Study Status v7
Primary completion date2024-06→2025-03
Completion date2026-07→2027-04
2023-09-11
Study Status, Oversight v6
Re-verified, no change to tracked fields
2022-08-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-07→confirmed 2022-07-20
Study sitesdetails revised at 4 of 4 sites
2022-06-02
Study Status, Contacts/Locations v4
Start date2022-05→2022-07
Study sites3→4
2022-04-14
Study Status, Contacts/Locations v3
Start date2022-03→2022-05
Study sites1→3
2022-03-14
Study Status v2
Start date2022-02→2022-03
2022-01-31
Study Identification, Study Status, Contacts/Locations v1
Study sites0→1
Study title-6 characters
Phase 3A Study of MT-0551 in Patients With Systemic Sclerosis
2022-01-06
Original filing
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.
Trial Details
NCT Number NCT05198557
Lead Sponsor Tanabe Pharma Corporation
Conditions Systemic Sclerosis
Enrollment 80 participants
Start Date 2022-07-20
Primary Completion 2025-07-31 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-08