A Phase 2 Study of the Safety and Efficacy of Brepocitinib in Adults With Cutaneous Sarcoidosis (BEACON)

ConditionCutaneous Sarcoidosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorPriovant Therapeutics, Inc.

About this trial

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults subjects (18-74)

Cutaneous sarcoidosis with characteristic skin biopsy histology

A CSAMI activity score ≥ 10

Weight > 40 kg to < 130 kg with BMI < 40 kg/m2 .

Disqualifiers

History of

Lymphoproliferative disorder

Active malignancy;

History of cancer within 5 years prior to baseline (exceptions for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix).

Trial design

Design model

Parallel

Treatments tested in this trial

Oral Brepocitinib
Drug
Drug: Oral Brepocitinib
Oral Placebo
Drug
Drug: Oral Placebo

Treatment groups

28 Participants

are divided into 3 treatment groups

Group A: Brepocitinib Dose Level 1Experimental treatment 1 intervention

Group B: Brepocitinib Dose Level 2Experimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

Time frame

Screening up to 28 days after the last dose of study drug at 16 weeks

Secondary outcomes

Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16.

CSAMI-A score is a measure of cutaneous sarcoidosis disease activity. A higher score indicates worse disease. Scores range from 0-165.

Time frame

16 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Priovant Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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