Brepocitinib for Cutaneous Sarcoidosis

(BEACON Trial)

Recruiting at 3 trial locations

Overseen By Clinical Trial Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Priovant Therapeutics, Inc.

Disqualifiers: Lymphoproliferative disorder, Active malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of an oral medication called brepocitinib for treating cutaneous sarcoidosis, a skin condition that causes lumps or patches. It compares brepocitinib at two different doses against a placebo (a non-active pill) to determine which works best. The trial seeks adults with a confirmed diagnosis of cutaneous sarcoidosis that noticeably impacts their skin. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that brepocitinib is likely to be safe for humans?

Research shows that brepocitinib is being tested for safety in treating skin sarcoidosis. Although detailed safety data for this specific condition is not yet available, its presence in a Phase 2 trial indicates it has demonstrated some safety in earlier tests. Phase 2 trials assess both safety and efficacy, confirming it has passed initial safety checks.

Brepocitinib has been studied for other conditions, providing insights into its safety profile. Past studies identified common mild side effects, such as headaches, nausea, or fatigue. Serious side effects are rare, but researchers will continue to monitor participants during the trial to ensure their safety.

Overall, past research suggests brepocitinib is well-tolerated. However, joining a clinical trial always involves some uncertainty, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cutaneous sarcoidosis?

Brepocitinib is unique because it targets a novel pathway in the treatment of cutaneous sarcoidosis. Unlike traditional treatments that often involve corticosteroids or immunosuppressants, Brepocitinib is a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in inflammation. This targeted approach may lead to fewer side effects and potentially more effective management of the condition. Researchers are excited because this could offer a new option for patients who have not responded well to existing therapies.

What evidence suggests that brepocitinib might be an effective treatment for cutaneous sarcoidosis?

Research has shown that brepocitinib may help treat inflammatory conditions. In a previous study, participants taking brepocitinib showed significant symptom improvement compared to those taking a placebo, with average scores of 46.5 for brepocitinib and 31.2 for the placebo group. This trial will test brepocitinib at different dose levels to evaluate its effectiveness in reducing inflammation and easing symptoms in conditions like cutaneous sarcoidosis. Brepocitinib targets specific parts of the immune system that cause inflammation. These findings offer hope that it could help people with cutaneous sarcoidosis feel better. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with cutaneous sarcoidosis, a skin condition causing red or purple bumps. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

CSAMI activity score ≥ 10

I have been diagnosed with skin sarcoidosis confirmed by a skin biopsy.

My weight is between 40kg and 130kg, and my BMI is under 40.

Exclusion Criteria

I have a history of cancer.

I currently have or recently had an infection.

I am at high risk for blood clots or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral brepocitinib or placebo for cutaneous sarcoidosis

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brepocitinib

Trial Overview The study tests the safety and effectiveness of an oral medication called Brepocitinib compared to a placebo in treating cutaneous sarcoidosis. It's likely that participants will be randomly assigned to either receive Brepocitinib or a placebo.

How Is the Trial Designed?

Group I: Brepocitinib Dose Level 2 Experimental Treatment 1 Intervention

Group II: Brepocitinib Dose Level 1 Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Priovant Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

570+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06978725?term=BREPOCITINIB&rank=5

A Phase 2 Study of the Safety and Efficacy of Brepocitinib ... Study Overview. Brief Summary. This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.

2. investor.roivant.com investor.roivant.com/news-releases/news-release-details/roivant-and-priovant-announce-positive-phase-3-valor-study

Roivant and Priovant Announce Positive Phase 3 VALOR ... On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2 for placebo (p=0.0006​). A statistically ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20581310

A Phase 2 Study Of The Safety And Efficacy Of Brepocitinib ... This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis. Participation ...

4. sarcoidosisnews.com sarcoidosisnews.com/news/brepocitinib-phase-2-trial-doses-first-cutaneous-sarcoidosis-patients/

Brepocitinib Phase 2 trial doses first cutaneous sarcoidosis ... As such, brepocitinib is expected to reduce inflammation and ease symptoms of sarcoidosis and other inflammatory diseases. The therapy was ...

5. globenewswire.com globenewswire.com/news-release/2025/09/17/3151491/34323/en/Roivant-and-Priovant-Announce-Positive-Phase-3-VALOR-Study-Results-for-Brepocitinib-in-52-Week-Placebo-Controlled-Trial-in-Dermatomyositis-DM.html

Roivant and Priovant Announce Positive Phase 3 VALOR ... On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2 for placebo (p=0.0006​). A statistically ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06978725

NCT06978725 | A Phase 2 Study of the Safety and Efficacy ... This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis. Official Title. A Phase 2 Randomized, ...

7. trialx.com trialx.com/clinical-trials/listings/312780/a-phase-2-study-of-the-safety-and-efficacy-of-brepocitinib-in-adults-with-cutaneous-sarcoidosis-beacon/

A Phase 2 Study of the Safety and Efficacy of Brepocitinib ... Overview. This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.