Health TrialsbyHealthPanel

A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis

ConditionCutaneous Sarcoidosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
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

Cutaneous sarcoidosis with characteristic skin biopsy histology

A CSAMI activity score ≥ 10

Weight > 40 kg to < 130 kg, and with a body mass index (BMI) ≤ 45 kg/m2.

Disqualifiers

History of cancer, with the exception of the following cancers with documentation of complete resection and no evidence of recurrence for ≥ 1 year: basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix.

High risk of thrombosis or cardiovascular disease

High risk of herpes zoster

Active or recent infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Brepocitinib

    Drug

    Oral Brepocitinib

  • Oral Placebo

    Drug

    Placebo

Treatment groups

168 Participants
are divided into 5 treatment groups
Group A: Part 1: Brepocitinib Dose Level 1Experimental treatment 1 intervention
Group B: Part 1: Brepocitinib Dose Level 2Experimental treatment 1 intervention
Group C: Part 1: PlaceboPlacebo comparator 1 intervention
Group D: Part 2: Brepocitinib Dose Level 1Experimental treatment 1 intervention
Group E: Part 2: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

Time frame
Week 16
2

Part 2: Proportion of participants achieving a reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16.

Time frame
16 Weeks

Secondary outcomes

1

Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score

Time frame
16 Weeks
2

Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score

Time frame
16 weeks

Other outcomes

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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