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

NCT02682511 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CPI-IFE-004
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 13

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).

Conditions

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

Keywords

Ifetroban; Scleroderma; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

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

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

  56 weeks

Secondary Outcomes (3)

• Change from baseline in forced vital capacity (FVC)

  Baseline, 12, 26, and 52 weeks

• Change from baseline in diffusion capacity for carbon monoxide (DLCO)

  Baseline, 12, 26, and 52 weeks

• Change from baseline in the modified Rodnan skin score (mRSS)

  Baseline, 12, 26, 39, and 52 weeks

Other Outcomes (11)

• Change from baseline in ventricular function as determined by cardiac MRI

  Baseline, 26, and 52 weeks

• Change from baseline in ventricular function as determined by echocardiography

  Baseline, 26, and 52 weeks

• Improve skin and peripheral vascular disease as measured by active digital ulcer count

  Baseline, 12, 26, 39, and 52 weeks

Study Arms (2)

Patients with dcSSc

EXPERIMENTAL

Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days

Drug: Oral Ifetroban; Drug: Oral Placebo

Patients with SSc-PAH

EXPERIMENTAL

Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days

Drug: Oral Ifetroban; Drug: Oral Placebo

Interventions

Oral Ifetroban DRUG

Subjects will be treated with oral ifetroban or placebo daily for 365 days

Also known as: Ifetroban

Patients with SSc-PAH; Patients with dcSSc

Oral Placebo DRUG

Subjects will be treated with oral ifetroban or placebo daily for 365 days

Also known as: Ifetroban

Patients with SSc-PAH; Patients with dcSSc

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• SSc-PAH 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

You may not qualify if:

• 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;
• Significant lung disease, defined as FVC \< 50% predicted or DLCO \<40% predicted;
• Significant kidney disease, defined as Glomerular Filtration Rate (GFR) \< 60 ml/min;
• Have moderate or severe hepatic impairment;
• Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
• Known hypersensitivity to gadolinium;
• Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
• Use of aspirin \> 81 mg per day in the last two weeks;

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (13)

The Universtity of Arizona Arthrtis Center

Tucson, Arizona, 85724, United States

Location

UCLA

Los Angeles, California, 90095-1670, United States

Location

Cleveland Clinic - Florida

Weston, Florida, 33331, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Baylor Research Institute

Dallas, Texas, 75204-651, United States

Location

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

KDH - Kokilaben Dhirubhai Ambani Hospital

Mumbai, Maharashtra, 400053, India

Location

B. J. Government Medical College

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; Scleroderma, Limited; Skin Diseases; Connective Tissue Diseases; Pathologic Processes; Autoimmune Diseases

Interventions

ifetroban

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Evan Brittain, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 15, 2016
• Study Start: January 1, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3); US (10)