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NCT04440592 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, sponsored by Tanabe Pharma America.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT04440592: Completed Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, sponsored by Tanabe Pharma America.
NCT04440592 is a Phase 2 study of Diffuse Cutaneous Systemic Sclerosis that has completed, run by Tanabe Pharma America. The registered enrollment target is 76 participants, below the 92-participant average among 6 other Diffuse Cutaneous Systemic Sclerosis trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04440592, a Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, has completed, sponsored by Tanabe Pharma America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
Primary Outcome
The comparison between MT-7117 treatment group and placebo group will be performed. The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MT-7117
Study Locations (20)
Other
- Universitair Ziekenhuis Gent - Ghent
- Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Liège
- Internistisches Zentrum des Universitaetsklinikums Erlangen - Erlangen
California
- Pacific Arthritis Care Center - Los Angeles
- The Board of Trustees of the Leland Stanford Junior University - Redwood City
Florida
- GNP Research - Hollywood
- Millennium Research - Ormond Beach
Arizona
- Arizona Arthritis - Glendale
Connecticut
- Yale School of Medicine - The Anlyan Center (TAC) for Medical Research & Education - New Haven
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2024-02-14 |
| Phase | Phase 2 |
What the finished NCT04440592 record still lists
NCT04440592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 92-participant average among 6 other Diffuse Cutaneous Systemic Sclerosis trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Diffuse Cutaneous Systemic Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04440592 names 20 study sites across 16 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04440592 about?
NCT04440592 is a clinical study titled "Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis". To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
What is the current status of trial NCT04440592?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2021-02-05. Estimated completion is 2024-02-14.
What conditions does trial NCT04440592 study?
This clinical trial studies the following conditions: Diffuse Cutaneous Systemic Sclerosis.
What interventions are being tested in trial NCT04440592?
The interventions under investigation include: Placebo (DRUG), MT-7117 (DRUG).
Who is sponsoring clinical trial NCT04440592?
This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04440592 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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