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

NCT04440592 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MT-7117-G02
• Study Type: interventional
• Target: 76
• Locations: 8 countries
• Sites: 34

Brief 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

Outcome Measures

Primary Outcomes (1)

• The ACR CRISS Composite Score (0-1) at Week 52

  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.

  Week 52

Secondary Outcomes (7)

• Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52

  52 weeks

• Change in Percent Predicted Forced Vital Capacity (%pFVC) From Baseline up to Week 52

  52 weeks

• Change in Patient Global Assessment From Baseline up to Week 52

  52 weeks

• Change in Physician Global Assessment From Baseline up to Week 52

  52 weeks

• Change in Modified Rodnan Skin Score (mRSS) From Baseline From Baseline up to Week 52

  52 weeks

Study Arms (2)

MT-7117

EXPERIMENTAL

Oral tablet of MT-7117 once a day.

Drug: MT-7117

Placebo

PLACEBO COMPARATOR

Oral tablet of placebo once a day.

Drug: Placebo

Interventions

MT-7117 DRUG

MT-7117

Also known as: Dersimelagon

MT-7117

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet all the following criteria will be considered eligible to participate in the study:
• Must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able to (in the judgment of the Investigator) understand the nature of the study and all risks involved with participation in the study. Subjects must be willing to cooperate and comply with all protocol restrictions and procedures including study visits.
• Male or female age ≥ 18 years at screening with documented diagnosis of systemic sclerosis (SSc), as defined using the 2013 ACR/European League Against Rheumatism (EULAR) criteria.
• Has diffuse cutaneous form of SSc according to Leroy and Medsger's criteria.
• Disease duration ≤ 5 years from the first non-Raynaud's phenomenon manifestation.
• Has an mRSS of 15 to 45 units at screening and have clinical skin involvement proximal and distal to the elbows, knees, or both or any truncal involvement, with or without face involvement.
• If disease duration is \> 24 months defined as time from the first non Raynaud phenomenon manifestation, subject must fulfill at least 1 of the criteria listed below that are indicatives of active disease at screening:
• A documentation of new skin involvement that occurred within the past 9 months, or
• Increase in mRSS ≥ 3 units within the past 9 months, or
• Presence of TFRs or,
• C- reactive protein (CRP) ≥ 6 mg/L, or
• Erythrocyte sedimentation rate ≥ 28 mm/hr, or
• Platelet count ≥ 330 x 10\^9/L (330,000/microliter).
• NOTE: Investigator should exclude all other acute intercurrent illness if subjects fulfilling laboratory criteria (d, e, f) only.
• Willing to follow restrictions regarding concomitant medications that are described.

You may not qualify if:

• \- Subjects will be excluded from the study if any of the following criteria apply:
• Has a history or presence of rheumatic autoimmune diseases other than dcSSc unless the dominant features of the disease are dcSSc, as determined by the Investigator.
• Has a pulmonary disease with FVC ≤ 50% of predicted at time of screening.
• Has a diagnosis of clinically significant resting pulmonary hypertension (if exceeding estimated right ventricular systolic pressure of \> 40 mmHg estimated by transthoracic echocardiography \[unless the right heart catheterization is normal within the last 6 months\] or mean pulmonary artery pressure \> 30 mmHg as measured by right heart catheterization) and requires treatment with more than one oral medication.
• Has a cardiac abnormality such as left ventricular failure with ejection fraction \< 45%, significant arrhythmia, congestive heart failure (New York Heart Association Class II-IV), unstable angina, uncontrolled hypertension, or symptomatic pericardial effusion at screening.
• Has a history of myocardial infarction in the last 26 weeks prior to screening.
• Has a history of renal crisis within the past 52 weeks prior to screening.
• Has a documented history of chronic kidney disease (stage 4-5, an estimated glomerular filtration rate \[eGFR\] \< 30 mL/min at screening).
• Presence or history of hepatobiliary disease at screening, determined as clinically significant by the Investigator after the discussion with the Sponsor Medical Monitor.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≥ 2.0 × upper limit of normal (ULN), or total bilirubin \> 1.5 × ULN at screening.
• Has a history or presence of clinically significant disease not related to SSc \[neurologic, renal, endocrinal, gastrointestinal cardiovascular, hepatic, dermatologic, hematological, musculoskeletal, genitourinary, thromboembolic, advanced arteriosclerosis, hyperthyroidism, moderate to severe hypertension, immunologic disease, pulmonary (e.g., uncontrolled asthma, emphysema, chronic obstructive pulmonary disease) or any other disorder\] as determined by the Investigator at screening. Conditions deemed not-clinically significant according to the Investigator's discretion are acceptable.
• Has a history or presence of psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation and/or safety of the subject.
• Has any clinically significant disease or laboratory abnormality judged to be clinically significant by the Investigator and which may interfere with the study evaluation and/or safety of the subject at screening. Laboratory abnormalities include but not limited to any of the followings: Hemoglobin \< 9 g/dL; WBC \< 3,000/mm3 (\< 3 x 10\^9/L); platelets \< 100,000/mm3 (\<100 x 10\^9/L).
• Has a history of positive hepatitis B surface antigen, hepatitis C antibody, except for documented cure for the hepatitis B virus (HBV), defined as sustained, undetectable HBsAg and HBV DNA in serum and adequately treated hepatitis C virus (HCV) with documentation of sustained virologic response defined as undetectable HCV RNA at least 12 weeks after the end of treatment.
• Has a history of positive human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (34)

Arizona Arthritis

Glendale, Arizona, 85306, United States

Location

Pacific Arthritis Care Center

Los Angeles, California, 90045, United States

Location

The Board of Trustees of the Leland Stanford Junior University

Redwood City, California, 94063, United States

Location

Yale School of Medicine - The Anlyan Center (TAC) for Medical Research & Education

New Haven, Connecticut, 06519, United States

Location

GNP Research

Hollywood, Florida, 33024, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-5422, United States

Location

Shelby Research, LLC

Memphis, Tennessee, 38119, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

UZ Leuven

Leuven, Vlaam Gewest, 3000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

Location

Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis And Autoimmune Disease

Toronto, Ontario, M5T 3L9, Canada

Location

University Hospital Of Tuebingen

Tübingen, Baden-Wuettemberg, 72076, Germany

Location

CIRI, Centrum fur innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH) Am Klinikum der Johann Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, 60590, Germany

Location

Internistisches Zentrum des Universitaetsklinikums Erlangen

Erlangen, 91054, Germany

Location

University of Ferrara Azienda Ospedaliero-Universitaria Sant' Anna

Cona, Ferrera, 44124, Italy

Location

Universita degli Studi di Milano - Azienda Ospedaliera Istituto Ortopedico Gaetano Pini

Milan, Lombardy, 20122, Italy

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska

Elblag, 82-300, Poland

Location

Malopolskie Centrum Kliniczne

Krakow, 30-149, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Medyczne Centrum Hetmanska

Poznan, 60-218, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Institut d'Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

The Royal Free Hospital - Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• Ogasawara A, Ide R, Inoue S, Tsuda M, Teng R. Assessment of Potential Drug-Drug Interactions for Novel Oral Melanocortin-1 Receptor Agonist Dersimelagon. Pharmacol Res Perspect. 2025 Feb;13(1):e70069. doi: 10.1002/prp2.70069.

  PMID: 39887900 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma America, Inc.

information.US@mb.tanabe-pharma.com

Please email

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: February 5, 2021
• Primary Completion: January 17, 2024
• Study Completion: February 14, 2024
• Last Updated: December 30, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-12

Locations

ES (5); PL (7); CA (1); GB (2); IT (2); BE (3); US (11); DE (3)