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

NCT02682511 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-15

No results posted yet for this study

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).

Conditions

  • Scleroderma, Diffuse
  • Scleroderma, Systemic
  • Scleroderma, Limited
  • Sclerosis, Progressive Systemic
  • Skin Diseases
  • Connective Tissue Diseases
  • Pathologic Processes
  • Autoimmune Diseases

Interventions

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

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Evan Brittain, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682511 on ClinicalTrials.gov