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Diffuse Scleroderma clinical trials at University of California Health

7 in progress, 5 open to eligible people

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  • Brentuximab Vedotin for Systemic Sclerosis

    open to eligible people ages 18-70

    There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.

    at UCLA

  • Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis

    open to eligible people ages 18 years and up

    This is a phase 2, open-label, single-cohort, multicenter trial of belumosudil in subjects with Diffuse Cutaneous Systemic Sclerosis (dcSSc). An estimated total of 12 to 15 subjects will receive belumosudil 200 mg administered orally (PO) twice daily (BID) for 52 weeks. The primary analysis will be at 24 weeks.

    at UCLA

  • Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis

    open to eligible people ages 18-74

    The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with diffuse cutaneous Systemic Sclerosis (dcSSc).

    at UCLA

  • KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

    open to eligible people ages 18-100

    This randomized, placebo-controlled phase 2 study is seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Upon eligibility confirmation, a total of 60 adult subjects will be enrolled and randomized into 3 groups (1:1:1) to either receive orally administered belumosudil (200 mg once daily and 200 mg twice daily) or matched placebo for 28 weeks. Study drug dosing will be for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the subjects on belumosudil will continue on the same belumosudil dose whereas the subjects in the placebo group will be re-randomized to one of the belumosudil doses.

    at UCLA UCSD

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

    open to eligible people ages 18-80

    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).

    at UCLA

  • Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis

    Sorry, in progress, not accepting new patients

    Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands. This Phase 1 trial is designed to evaluate the safety, tolerability and preliminary efficacy of AVID200 in SSc patients in order delineate doses to be further evaluated in Phase 2. Approximately 9 to 24 male and female patients with documented SSc (i.e., score ≥ 9 according to the American College of Rheumatology/European League Against Rheumatism classification criteria), and classified as having the diffuse cutaneous SSs (dcSSc) subset (i.e., according to the LeRoy and Medsger Classification), will be entered into this Phase 1a, multicentre, open-label, dose-escalation, cohort study of AVID200.

    at UCLA

  • Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

    Sorry, not currently recruiting here

    To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52

    at UCLA UCSD

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