Active — Not RecruitingPhase 2

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

United States34 participantsStarted 2017-01

Plain-language summary

The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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
✓. Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
✓. New York Heart Association (NYHA) Class I-III Heart Failure

Exclusion criteria

✕. Have a diagnosis of systemic sclerosis sine scleroderma;
✕. Be less than 18 years of age or greater than or equal to 80 years of age;
✕. Be pregnant, nursing, or planning to become pregnant;
✕. Current or planned treatment with prostanoid therapy;
✕. Current or planned treatment with pirfenidone;
✕. Use of rituximab in the last 3 months;
✕. Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months;
✕. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;

What they're measuring

Incidence of adverse events (AEs) and Serious AEs (SAEs)

Timeframe: 56 weeks

Trial details

NCT IDNCT02682511

SponsorCumberland Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Scleroderma, Diffuse trials