Oral Ifetroban for Scleroderma
Recruiting in Palo Alto (17 mi)
+11 other locations
Overseen ByEvan Brittain, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Cumberland Pharmaceuticals
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing ifetroban, an oral medication, in patients with severe forms of systemic sclerosis. The goal is to see if it can reduce inflammation and improve blood flow, potentially helping to manage their condition better.
Do I need to stop my current medications to join the trial?
The trial requires that you have been on stable oral therapy for pulmonary arterial hypertension (PAH) for at least 30 days. However, you cannot participate if you are currently or planning to use certain medications like prostanoid therapy, pirfenidone, or high-dose corticosteroids, among others. Please review the exclusion criteria carefully to see if any apply to your current medications.
How is the drug Ifetroban unique in treating scleroderma?
Ifetroban is unique in treating scleroderma because it is administered orally, unlike some other treatments that require injections or more complex administration. It is also being explored as a novel option, as there are limited standard treatments specifically targeting scleroderma.
12345Eligibility Criteria
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.Inclusion Criteria
I was diagnosed with diffuse cutaneous systemic sclerosis within the last 7 years.
Exclusion Criteria
I am taking or will take more than 15mg of prednisone or its equivalent daily.
My lung function is significantly impaired.
My kidney function is reduced with a GFR under 60 ml/min.
I understand English and can follow the study's requirements.
I have been diagnosed with systemic sclerosis without skin thickening.
I am currently on or will start prostanoid therapy.
My liver function is significantly impaired.
I am either younger than 18 or 80 years old or older.
My pulmonary hypertension is not caused by scleroderma.
I am currently taking or will start taking pirfenidone.
Participant Groups
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.
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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Thomas Jefferson UniversityPhiladelphia, PA
The Universtity of Arizona Arthrtis CenterTucson, AZ
UCLALos Angeles, CA
Massachusetts General HospitalBoston, MA
More Trial Locations
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Who is running the clinical trial?
Cumberland PharmaceuticalsLead Sponsor
References
Comparison of aminobenzoate potassium and placebo in the treatment of scleroderma. [2013]To determine the safety and efficacy of aminobenzoate potassium (KPAB) in treating the skin manifestations of scleroderma.
Comparison of methotrexate with placebo in the treatment of systemic sclerosis: a 24 week randomized double-blind trial, followed by a 24 week observational trial. [2022]In this study, methotrexate (MTX) was compared with placebo in the treatment of systemic sclerosis (scleroderma, SSc) in a 24 week randomized double-blind trial, followed by an observational trial of 24 weeks duration. Twenty-nine scleroderma patients were allocated to receive weekly injections of either 15 mg MTX or placebo. Patients who responded favourably after 24 weeks continued with the same regimen for a further 24 weeks; those who showed a poor response on placebo were allocated to further treatment with 15 mg MTX weekly, and those who responded poorly to treatment with 15 mg MTX had their doses increased to 25 mg. A favourable response was defined as an improvement of total skin score (TSS) by > or = 30%, of single breath diffusion capacity (DLCO) by > or = 15%, or of the score on a visual analogue scale of general well-being (VAS) by > or = 30%, provided that such improvements were not accompanied by persistent digital ulcerations or worsening of DLCO > or = 15%. Seventeen patients were allocated to MTX treatment and 12 to treatment with placebo. After 24 weeks, a significantly larger number of patients receiving MTX (n = 8, 53%) who completed the first 24 weeks of the study had responded favourably compared to patients receiving placebo (n = 1, 10%, P = 0.03). Comparison of separate variables between the two treatment groups by intention-to-treat analysis at week 24 showed improvement in the MTX group of TSS (P = 0.06) and creatinine clearance (P = 0.07). At week 48, 13 patients received MTX from the start of the study and nine during 24 weeks. From these 22 patients, 15(68%) responded favourably and compared with the start of the study they showed significant improvement of TSS (P = 0.04), VAS (P = 0.02), grip strength of the right hand (P = 0.02) and ESR (P = 0.01). Although the number of patients enrolled in this study is small, these results suggest that in a group of patients with active systemic sclerosis, low-dose MTX seems to be more effective than placebo according to pre-defined response criteria.
Scleroderma (progressive systemic sclerosis, PSS); pathophysiological, clinical and pharmacological aspects of the syndrome. [2013]Scleroderma is an uncommon complex disease. The onset is slow and the progress is chronic. The main pathophysiological changes vary; they affect blood vessels, connective tissue, collagen fibres, cause fibrin deposition and inflammatory reactions. There may be early oedema and a wide spectrum of organic involvement. Clinically, all the fibril-containing and connective tissue organs can be attacked in various degrees. The most common organ manifestations are the Raynaud's phenomenon in the arms and hands, vascular fibrosis, stiff and hard facial skin, restriction of joint movement by pericapsular hardening, calcium deposition and capsular rigidity. In the gastrointestinal tract muscle atrophy, collagen and connective tissue damage are common, especially at the cardia. Malabsorption may occur. Progressive pulmonary fibrosis leads to cor pulmonale and respiratory insufficiency. The liver, kidneys and the endocrine glands are, however, seldom involved. Therapeutic trials have been performed using many different groups of drugs: vasodilatating agents, corticosteroids, drugs found experimentally to influence connective tissue, thyroxine and a variety of anti-rheumatic agents. In the last decade best short-term clinical results have been achieved with penicillamine, some vasodilators, chlorambucil and in recent years with cyclofenil a potent anti-oestrogen, which has marked connective tissue and collagen metabolism influencing properties. Good therapeutic effects without serious side effects have been achieved.
Successful combined medical and surgical treatment of a lower extremity sclerodermal ulcer. [2019]Combined medical and surgical treatment of a chronic lower extremity ulcer in a patient with systemic scleroderma is described. Recent pharmacological advances including calcium channel blockers, meticulous surgical care, and skin grafting offer promise for more consistent wound closure in sclerodermal skin ulcerations.
Efficacy of Bosentan in treatment of refractory sclerodermic bone prominences skin ulcers. [2018]Scleroderma is an autoimmune disease characterized by skin and internal organs involvement. Cutaneous ulcerations is one of the most important complication. It may cause pain, disability and may lead to infections, scarring and amputation. Sclerodermic skin ulcers management is quite complex and involves non-pharmacologic and pharmacologic modalities both for the treatment and the prevention. In this report, authors describe a case of refractory skin ulcerations in a sclerodermic patient treated with endothelin receptor antagonist Bosentan. Bosentan changed the course of cutaneous lesions leading to their complete healing. This treatment represents an alternative therapeutic approach for sclerodermic skin ulcers and it may be taken into consideration for the ongoing development of a new management of cutaneous wounds.