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New drug hope for scleroderma patients with lung complications

NCT ID NCT02682511

Disease control Sponsor: Cumberland Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests an experimental drug called ifetroban in 34 adults with a severe form of scleroderma (diffuse cutaneous systemic sclerosis) or scleroderma-related lung disease (pulmonary arterial hypertension). The main goal is to see if the drug is safe and whether it can improve lung function compared to a placebo. Participants are randomly assigned to receive ifetroban or a dummy pill, and neither they nor their doctors know which they are getting.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 34 people

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

Started

Jan 2017

Expected to finish

Sep 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

18 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: Diffuse Cutaneous Criterion: 1\. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first non-Raynaud symptom. SSc-PAH Criteria: 1. Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization 2. Stable oral therapy for PAH for at least 30 days (monotherapy or combination) 3. New York Heart Association (NYHA) Class I-III Heart Failure Exclusion Criteria: 1. Have a diagnosis of systemic sclerosis sine scleroderma; 2. Be less than 18 years of age or greater than or equal to 80 years of age; 3. Be pregnant, nursing, or planning to become pregnant; 4. Current or planned treatment with prostanoid therapy; 5. Current or planned treatment with pirfenidone; 6. Use of rituximab in the last 3 months; 7. Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months; 8. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent; 9. Significant lung disease, defined as FVC \< 50% predicted or DLCO \<40% predicted; 10. Significant kidney disease, defined as Glomerular Filtration Rate (GFR) \< 60 ml/min; 11. Have moderate or severe hepatic impairment; 12. Contraindication to MRI (e.g., implanted magnetic material, claustrophobia); 13. Known hypersensitivity to gadolinium; 14. Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc; 15. Use of aspirin \> 81 mg per day in the last two weeks; 16. Use of warfarin, heparin or other anticoagulants in the last 30 days; 17. Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias; 18. Have a history of allergy or hypersensitivity to ifetroban; 19. Have taken investigational drugs within 30 days before study treatment administration; 20. Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments; 21. Be otherwise unsuitable for the study, in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

autoimmune disease connective tissue disorder diffuse cutaneous systemic sclerosis diffuse scleroderma limited cutaneous systemic sclerosis Pathologic Processes skin disorder systemic sclerosis

As listed by the trial registrant

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

Autoimmune diseases Connective tissue diseases Pathologic processes Scleroderma, diffuse Scleroderma, limited Scleroderma, systemic Sclerosis, progressive systemic Skin diseases

Contacts and locations

Locations

  • B. J. Government Medical College

    Pune, Maharashtra, 411001, India

  • Baylor Research Institute

    Dallas, Texas, 75204-651, United States

  • Cleveland Clinic - Florida

    Weston, Florida, 33331, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • KDH - Kokilaben Dhirubhai Ambani Hospital

    Mumbai, Maharashtra, 400053, India

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29403, United States

  • PGIMER

    Chandigarh, Chandigarh, 160012, India

  • The Universtity of Arizona Arthrtis Center

    Tucson, Arizona, 85724, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA

    Los Angeles, California, 90095-1670, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.