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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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.
Sponsor: Cumberland Pharmaceuticals

Current Primary Outcome: Incidence of adverse events (AEs) and Serious AEs (SAEs) [ Time Frame: 56 weeks ]

Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in forced vital capacity (FVC) [ Time Frame: Baseline, 12, 26, and 52 weeks ]
    To determine if ifetroban improves pulmonary function in subjects with diffuse cutaneous SSc or SSc-PAH compared to placebo as measured by a change from baseline FVC.
  • Change from baseline in diffusion capacity for carbon monoxide (DLCO) [ Time Frame: Baseline, 12, 26, and 52 weeks ]
    To determine if ifetroban improves pulmonary function in subjects with diffuse cutaneous SSc or SSc-PAH compared to placebo as measured by a change from baseline diffusion capacity for carbon monoxide (DLCO)
  • Change from baseline in the modified Rodnan skin score (mRSS) [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
    The efficacy of treatment on skin fibrosis will be measured by changes from baseline in mRSS, a measure of skin thickness, at 52 weeks.


Original Secondary Outcome: Same as current

Information By: Cumberland Pharmaceuticals

Dates:
Date Received: February 8, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: February 22, 2017
Last Verified: February 2017