BEACON (Cutaneous Sarcoidosis) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called brepocitinib (the study drug) is a safe and effective option for people with cutaneous sarcoidosis.

What is the Condition Being Studied?

Cutaneous Sarcoidosis

Who Can Participate in the Study?

Adults ages 18-75 who:

  • Have been experiencing symptoms of cutaneous sarcoidosis for at least 6 months
  • Weigh at least 88 pounds

For more information, contact the study team at erin.campo@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 groups:

  • Group 1: If you are in this group, you will get a 15 mg dose of the study drug. OR
  • Group 2: If you are in this group, you will get a 45 mg dose of the study drug. OR
  • Group 3: If you are in this group, you will get a placebo (inactive substance with no drug in it, i.e. a "sugar pill")

During your participation in this study, you will have the following tests and procedures:

  • Physical exams
  • Blood works
  • Breathing tests
  • ECG
  • X-ray
  • Urine testing
  • Vital signs
  • Completing questionnaires and diaries

While you are taking the study drug or placebo, you will have at least 5 clinic visits that last 2-3 hours each.

Because there is a chance you may receive placebo, you are allowed to stay on some of your current sarcoidosis medications while you are in the study. If you are taking corticosteroids ("steroids"), the steroid dose will be decreased. Your study doctor will assess this and discuss all medication changes with you.

During the follow-up period, you will have one clinic visit about 4 weeks after your last dose of the study drug that will last about 2 hours.

Study Details

Full Title
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
Principal Investigator
Protocol Number
IRB: PRO00117098
Phase
Phase II
Enrollment Status
Open for Enrollment