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New drug aims to soften skin in rare autoimmune disease

NCT ID NCT05198557

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called MT-0551 against a placebo in 80 adults with systemic sclerosis, a disease that causes skin thickening and can affect internal organs. The main goal is to see if the drug reduces skin hardness over 26 weeks. Researchers will also check lung function and safety. Participants must have moderate skin thickening and no severe lung complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Additional screening criteria check may apply for qualification: 1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied. 2. Skin thickening score based on the mRTSS between 10 and 22 inclusive. Exclusion Criteria: Additional screening criteria check may apply for qualification: 1. Pulmonary hypertension associated with SSc. 2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia. 3. Finding of inadequate respiratory reserve capacity. 4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab. 5. Presence of a clinically significant active infection requiring antimicrobial therapy. 6. A past history of cancer. 7. Past history of a recurrent, clinically significant infection. 8. Past history of severe allergy or anaphylactic reaction to a biologic drug product. 9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic sclerosis

Contacts and locations

Locations

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655, Japan

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193, Japan

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