Title

Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase 2 studies

Document Type

Article

Publication Date

1-2-2022

Publication Title

The British journal of dermatology

Abstract

BACKGROUND: Janus kinase (JAK)-mediated cytokine signaling contributes to local and systemic inflammation in hidradenitis suppurativa (HS).

OBJECTIVES: To describe safety and efficacy results from two multicenter phase 2 trials of the JAK1 inhibitor INCB054707 in patients with moderate-to-severe HS.

METHODS: Patients received open-label 15 mg INCB054707 once daily (QD; Study 1) or were randomized to 30, 60, or 90 mg INCB054707 QD or placebo (3:1 within each cohort; Study 2) for 8 weeks. Eligible patients were aged 18-75 years with moderate-to-severe HS (Hurley stage II/III disease), lesions present in ≥2 anatomic locations, and a total abscess and inflammatory nodule count ≥3. The primary endpoint for both studies was safety and tolerability. Secondary endpoints included HS Clinical Response (HiSCR) and other efficacy measures.

RESULTS: Ten patients were enrolled in Study 1 (15 mg INCB054707) and 35 in Study 2 (INCB054707: 30 mg, n=9; 60 mg, n=9; 90 mg, n=8; placebo: n=9). Overall, 70·0% of patients in Study 1 and 80·8% of patients receiving INCB054707 in Study 2 experienced ≥1 treatment-emergent adverse event (TEAE); 30·0% and 42·3% of patients, respectively, had ≥1 treatment-related TEAE. Among evaluable patients, 3 patients (42∙9%) in Study 1 and 17 patients (overall 65·4%: 30 mg, 55·6%; 60 mg, 55·6%; 90 mg, 87·5%) receiving INCB054707 versus 4 patients (57·1%) receiving placebo in Study 2 achieved HiSCR at Week 8.

CONCLUSIONS: INCB054707 was well tolerated, with responses observed in patients with moderate-to-severe HS. Safety and efficacy findings from these studies demonstrate proof of concept for JAK1 inhibition in HS (ClinicalTrials.gov identifiers, NCT03569371, NCT03607487).

PubMed ID

34978076

ePublication

ePub ahead of print

Share

COinS