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Diffuse Cutaneous Systemic SclerosisPhase 2NCT04440592

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

A Phase 2 study testing MT-7117 in people with Diffuse Cutaneous Systemic Sclerosis, run by Tanabe Pharma America, Inc. at 34 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Cutaneous Systemic Sclerosis
What is being tested?
MT-7117
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
34 sitesin 8 countries
Study dates
5 Feb 2021to 14 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.
  • Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
  • Female subjects of childbearing potential and male subjects with partner of child-bearing potential currently using/willing to use 2 effective methods of contraception including barrier method as described.

Who cannot join

  • 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.
Show all 40Show fewer
  • 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)
  • Has a history of melanoma, familial melanoma (defined as having 2 or more first-degree relatives, such as parent, sibling, and/or child), or presence of melanoma and/or lesions suspicious for melanoma at screening.
  • Has a presence of squamous cell carcinoma, basal cell carcinoma, or other malignant skin lesions. Any suspicious lesions or nevi (Melanocytic Lesions) will be evaluated. If the suspicious lesion or nevi (Melanocytic Lesions) cannot be resolved through biopsy or excision, the subject will be excluded from the study.
  • Has history of any other malignancy(ies) in the last 5 years with the exception of cervical carcinoma in situ.
  • Has a history or planning to receive cell-depleting therapy or bone marrow transplantation during study treatment period.
  • Has a history of ultraviolet (UV) phototherapy within 6 weeks prior to screening or planning to receive UV phototherapy during study treatment period.
  • Treatment of SSc disease with
  • Cyclophosphamide, rituximab, or cyclosporine received within 26 weeks prior to screening.
  • Small molecules such as JAK inhibitors (e.g., tofacitinib) received within 12 weeks prior to screening.
  • Pirfenidone received within 12 weeks prior to screening.
  • Infliximab, certolizumab, golimumab, adalimumab, abatacept, tocilizumab within 10 weeks prior to screening.
  • Etanercept within 4 weeks prior to screening.
  • Oral, intravenous, or intramuscular corticosteroids (prednisone > 10 mg/day or equivalent) received within 30 days prior to screening
  • Nintedanib within 12 weeks prior to screening.
  • More than 1 of the immunosuppressant therapy listed below as concomitant therapy with study drug, has changed one of the medication below within 12 weeks prior to screening, or not on a stable dose of the same medication for at least 12 weeks prior to screening.
  • i. Mycophenolate (up to 3 g/day), or
  • ii. Mycophenolic acid (up to 2.14 g/day), or
  • iii. Methotrexate (up to 25 mg/Week), or
  • iv. Leflunomide (up to 20 mg/day), or
  • v. Azathioprine (up to 3 mg/kg/day).
  • Treatment with afamelanotide or other MC1R agonist within 12 weeks before screening (Visit 1).
  • Treatment with any drugs or supplements which, in the opinion of the Investigator, may interfere with the objectives of the study or safety of the subject.
  • Has previously exposed to MT 7117 (this does not include placebo treated subjects).
  • Has previously treated with any investigational agent within 12 weeks prior to screening OR 5 half-lives of the investigational product (whichever is longer).
  • Female subjects who are pregnant, lactating, or intending to become pregnant during the study.
  • Has a positive autoantibody status of anti-centromere antibody.

Trial locations and contacts

34 sites in 8 countries.

34 sites in 8 countries

United States11 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-5422

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Arizona Arthritis

    Glendale, Arizona, 85306

  • GNP Research

    Hollywood, Florida, 33024

  • The University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Pacific Arthritis Care Center

    Los Angeles, California, 90045

  • Shelby Research, LLC

    Memphis, Tennessee, 38119

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

    New Haven, Connecticut, 06519

  • Millennium Research

    Ormond Beach, Florida, 32174

  • The Board of Trustees of the Leland Stanford Junior University

    Redwood City, California, 94063

Other trials in United States

Poland7 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

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

    Elblag, 82-300

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Medyczne Centrum Hetmanska

    Poznan, 60-218

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

Spain5 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Málaga

    Málaga, 29009

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

    Sabadell, Barcelona, 08208

Other trials in Spain

Belgium3 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, Vlaam Gewest, 3000

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

    Liège, 4000

Other trials in Belgium

Germany3 sites

  • Internistisches Zentrum des Universitaetsklinikums Erlangen

    Erlangen, 91054

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

    Frankfurt am Main, Hesse, 60590

  • University Hospital Of Tuebingen

    Tübingen, Baden-Wuettemberg, 72076

Other trials in Germany

Italy2 sites

  • University of Ferrara Azienda Ospedaliero-Universitaria Sant' Anna

    Cona, Ferrera, 44124

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

    Milan, Lombardy, 20122

Other trials in Italy

United Kingdom2 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • The Royal Free Hospital - Royal Free London NHS Foundation Trust

    London, NW3 2QG

Other trials in United Kingdom

Canada1 site

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

    Toronto, Ontario, M5T 3L9

Other trials in Canada

About this study

Official title: 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

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

Being tested
MT-7117, Placebo
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MT-7117Drug

    Also called Dersimelagon

    MT-7117

  • PlaceboDrug

    Placebo

Study groups in NCT04440592
Study groupRoleWhat they receive
MT-7117ExperimentalOral tablet of MT-7117 once a day.
Receives: Drug: MT-7117
PlaceboPlacebo comparatorOral tablet of placebo once a day.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 52

Secondary outcomes (7)

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

    To evaluate the efficacy of MT 7117 treatment for up to 52 weeks using the Health Assessment Questionnaire Disability Index (HAQ DI). The Health Assessment Questionnaire Disability Index (HAQ-DI) is a self-administered instrument consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. Overall score was computed as the sum of component set scores and divided by the number of component sets answered. This outcome measure represents the change in mean score from baseline. A negative change from baseline indicates improvement.

    Measured: 52 weeks

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

    To evaluate the efficacy of MT-7117 treatment for up to 52 weeks on pulmonary function as measured by percent predicted forced vital capacity (%pFVC)

    Measured: 52 weeks

  3. Change in Patient Global Assessment From Baseline up to Week 52

    To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the Patient Global Assessment

    Measured: 52 weeks

  4. Change in Physician Global Assessment From Baseline up to Week 52

    To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the Physician Global Assessment. The Physician Global Assessment is used to assess the physician's rating of overall health of the subject. Physicians rate the perceived health of the subject on an 11-point scale from 0 (excellent) to 10 (extremely poor).

    Measured: 52 weeks

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

    To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the modified Rodnan Skin Score (mRSS). mRSS evaluates a subject's skin thickness which will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units.

    Measured: 52 weeks

  6. ACR CRISS Score up to Week 39

    To evaluate the efficacy of MT 7117 treatment for up to 39 weeks using the ACR CRISS Score. 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.

    Measured: 39 weeks

  7. ACR CRISS Score Responder (CRISS>=0.6) From Baseline up to Week 52

    To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using CRISS Score. Subjects with CRISS score is >=0.60 are considered improved, while subjects with CRISS score < 0.60 are considered not improved.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start5 Feb 2021
  3. Primary completion17 Jan 2024
  4. Study completion14 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04440592
Sponsor's protocol ID
MT-7117-G02
Status last verified
Dec 2025
First submitted
17 Jun 2020
Last updated
30 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39887900

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MT-7117 in people with Diffuse Cutaneous Systemic Sclerosis, run by Tanabe Pharma America, Inc. at 34 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Poland, Spain, Belgium, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The ACR CRISS Composite Score (0-1) at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440592, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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