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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this study is to measure clinical safety and efficacy of oral brepocitinib in adult participants with cutaneous sarcoidosis.

Study details include:

Up to 30 days for screening (Screening Period), then 16 weeks of treatment with double-blinded treatment with either brepocitinib 45 mg, brepocitinib 15 mg, or placebo (Treatment Period) QD, then 4 weeks for safety follow-up (Off-Drug Follow-Up Period) The visit frequency is every 4 weeks. Ongoing standard of care (that meets eligibility criteria requirements) will be maintained during the Treatment Period. Participants who are receiving ongoing oral corticosteroids at baseline will undergo a mandatory taper (starting with Day 15, Week 2) and discontinue oral corticosteroids on or before Day 57 (Week 8).

Details

Protocol number PVT-2201-203

Eligibility

Current sarcoidosis disease presentation consistent with any of the following:聽

Solely subcutaneous sarcoidosis; Solely nongranulomatous or nonspecific cutaneous sarcoidosis lesions (e.g., erythema nodosum); Solely ulcerative lesions; Lofgren鈥檚 syndrome

History of any lymphoproliferative disorder (such as Epstein-Barr virus [EBV]-related lymphoproliferative disorder, lymphoma, leukemia). Cancer-associated condition, cancer, or history meeting any of the following conditions:

Active malignancy; History of cancer within 5 years prior to baseline

Severe hepatic impairment

Any of the following cardiovascular risk factors including the following:

Cardiac insufficiency Myocardial infarction (MI) within 1 year prior to baseline Coronary artery bypass graft surgery within 1 year prior to baseline

Recipient of a solid organ transplant who is currently receiving systemic immunosuppressive therapy. Any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass). Current therapy consisting of > 25 mg/day of prednisone or equivalent or a change in corticosteroid dose in the 4 weeks prior to baseline Current or planned treatment with prohibited concomitant medications, including biologic therapy (e.g., TNF inhibitors)聽

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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