Trials / Active Not Recruiting
Active Not RecruitingNCT02682511
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study is a randomized, placebo-controlled, double-blind phase 2 trial of patients with dcSSc or SSc-PAH. Twenty participants with SSc-PAH and 14 participants with dcSSc will be randomized to receive either oral ifetroban daily or matching placebo. Study participants will be treated for 12 months, followed by a 30-day follow-up period. The study will test whether ifetroban is safe and statistically superior to placebo in reducing the effects of their disease at month 12 and explore the ability of ifetroban to prevent or reverse progression in patients with early disease duration and reverse established disease in patients with longer disease duration.
Conditions
- Scleroderma, Diffuse
- Scleroderma, Systemic
- Scleroderma, Limited
- Sclerosis, Progressive Systemic
- Skin Diseases
- Connective Tissue Diseases
- Pathologic Processes
- Autoimmune Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral Ifetroban | Subjects will be treated with oral ifetroban or placebo daily for 365 days |
| DRUG | Oral Placebo | Subjects will be treated with oral ifetroban or placebo daily for 365 days |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2026-06-01
- Completion
- 2026-08-01
- First posted
- 2016-02-15
- Last updated
- 2026-04-15
Locations
13 sites across 2 countries: United States, India
Source: ClinicalTrials.gov record NCT02682511. Inclusion in this directory is not an endorsement.