NCT04440592

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	MT-7117	MT-7117
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-02-05
• Primary completion: 2024-01-17
• Completion: 2024-02-14
• First posted: 2020-06-19
• Last updated: 2025-12-30
• Results posted: 2025-11-03

Locations

34 sites across 8 countries: United States, Belgium, Canada, Germany, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study