Phase 2 N=35 Randomized Triple-blind Treatment

A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Hidradenitis Suppurativa

Bottom Line

View on ClinicalTrials.gov: NCT03607487 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Number of Treatment-emergent Adverse Events (TEAEs) — 2; 6; 4; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: INCB054707 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Incyte Corporation
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Treatment-emergent Adverse Events (TEAEs)	2; 6; 4; 1; 2; 2	—
SECONDARY Apparent Oral Clearance of INCB054707	5.27	—
SECONDARY Apparent Oral Volume of Distribution of INCB054707	239	—
SECONDARY Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit	1; 1; 4; 2; 6; 8	—
SECONDARY Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit	0; 0; 0; 1; 9; 9	—
SECONDARY Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit	0.2; -0.8; -0.3; -1.5; -0.1; -1.5	—
SECONDARY Mean Change From Baseline in the Modified Sartorius Scale Score	-36.4; -41.9; -59.2; -54.6	—
SECONDARY Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.	-0.1; -0.1; -0.8; -0.3; 0.0; -0.9	—
SECONDARY Proportion of Participants at Each Category of Hurley Stage	0; 0; 0; 0; 4; 9	—
SECONDARY Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period	0; 0; 0; 0; 0; 1	—
SECONDARY Actual Measurements in HS-PGIC at Each Visit	0; 0; 0; 0; 0; 1	—
SECONDARY Proportion of Participants With Change From Baseline Hurley Stage	0; 0; 0; 0; 4; 9	—

Summary

The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.

Eligibility Criteria

Inclusion Criteria

Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
Stable course of HS for at least 90 days before screening, as determined by the investigator.
HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or Hurley Stage III at screening.
Total AN count of at least 3 at screening and baseline.
Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

Women who are currently pregnant or lactating.
Presence of > 20 draining fistulas at screening and baseline.
Participants with protocol-defined concurrent conditions or history of other diseases.
Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
Decreased blood cell counts at screening per protocol-defined criteria.
Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
Use of protocol-prohibited medications.
Known or suspected allergy to INCB054707 or any component of the study drug.
Known history of clinically significant drug or alcohol abuse in the last year before baseline.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03607487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.