BEACON (Cutaneous Sarcoidosis)

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.

Who Can Participate?

Eligibility

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 Range

18-75

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Anne
Marano

Protocol Number

PRO00117098

Phase

II

Enrollment Status

Pending Open to Enrollment