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Thromboxane A2 Receptor Antagonist

Oral Ifetroban for Scleroderma

Phase 2
Recruiting
Led By Evan Brittain, MD
Research Sponsored by Cumberland Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diffuse Cutaneous Criterion: 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12, 26, 39, and 52 weeks
Awards & highlights

Study Summary

This trial will test ifetroban, a new drug, to see if it is safe and effective for treating scleroderma, a disease that causes the hardening and tightening of skin, or scleroderma-associated pulmonary arterial hypertension.

Who is the study for?
This trial is for adults under 80 with diffuse cutaneous systemic sclerosis (dcSSc) within 7 years of their first symptom or SSc-associated pulmonary arterial hypertension, confirmed by cardiac catheterization. They must be on stable oral PAH therapy and have NYHA Class I-III Heart Failure. Exclusions include recent heart issues, certain drug treatments, severe lung or kidney disease, MRI contraindications, hypersensitivity to ifetroban or gadolinium.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of an oral medication called Ifetroban compared to a placebo in patients with dcSSc or SSc-PAH. It's a phase 2 trial where participants are randomly assigned to either the treatment group receiving Ifetroban or a control group getting a placebo without knowing which one they're taking.See study design
What are the potential side effects?
While specific side effects for Ifetroban aren't listed here, common ones may include digestive discomforts like nausea or diarrhea, potential liver function changes, headaches, dizziness and possible allergic reactions. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with diffuse cutaneous systemic sclerosis within the last 7 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12, 26, 39, and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12, 26, 39, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs) and Serious AEs (SAEs)
Secondary outcome measures
Change from baseline in diffusion capacity for carbon monoxide (DLCO)
Change from baseline in forced vital capacity (FVC)
Change from baseline in the modified Rodnan skin score (mRSS)
Other outcome measures
Change from baseline in blood biomarkers
Change from baseline in erythrocyte sedimentation rate
Change from baseline in skin biomarkers
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with dcSScExperimental Treatment2 Interventions
Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Group II: Patients with SSc-PAHExperimental Treatment2 Interventions
Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Placebo
2017
Completed Phase 4
~3500

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
9,429 Total Patients Enrolled
Evan Brittain, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Ifetroban (Thromboxane A2 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02682511 — Phase 2
Ifetroban (Thromboxane A2 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02682511 — Phase 2
Connective Tissue Disease Clinical Trial 2023: Ifetroban Highlights & Side Effects. Trial Name: NCT02682511 — Phase 2
Connective Tissue Disease Research Study Groups: Patients with SSc-PAH, Patients with dcSSc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
2017. "Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02682511.
All > Pulmonary Arterial Hypertension > Scleroderma
~6 spots leftby Dec 2025
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