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

NCT03607487 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 54707-2032018-000827-15
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 13

Brief 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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa; Janus kinase (JAK) inhibitor; skin disease

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent Adverse Events (TEAEs)

  TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".

  Up to 12 weeks

Secondary Outcomes (11)

• Apparent Oral Clearance of INCB054707

  Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8

• Apparent Oral Volume of Distribution of INCB054707

  Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8

• Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit

  Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)

• Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit

  Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)

• Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit

  Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)

Study Arms (3)

Cohort 1

EXPERIMENTAL

INCB054707 at the Cohort 1 dose or placebo.

Drug: INCB054707; Drug: Placebo

Cohort 2

EXPERIMENTAL

INCB054707 at the Cohort 2 dose or placebo.

Drug: INCB054707; Drug: Placebo

Cohort 3

EXPERIMENTAL

INCB054707 at the Cohort 3 dose or placebo.

Drug: INCB054707; Drug: Placebo

Interventions

INCB054707 DRUG

INCB054707 tablet administered orally once daily at the protocol-defined dose.

Also known as: Povorcitinib

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Placebo tablet administered orally once daily.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (13)

Investigative Site

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigative Site

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Investigative Site

Barrie, Ontario, L4M 7G1, Canada

Location

Investigative Site

London, Ontario, N6H 5L5, Canada

Location

Investigative Site 009

Markham, Ontario, L3P 1X2, Canada

Location

Investigative Site 008

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Investigative Site 007

Windsor, Ontario, N8W 5L7, Canada

Location

Investigative Site

Drummondville, Quebec, J2B 5L4, Canada

Location

Investigative Site

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Investigative Site

Aarhus, 8200, Denmark

Location

Investigative Site

Roskilde, 4000, Denmark

Location

Investigative Site

Bochum, Noth Rhine-Westphalia, 44791, Germany

Location

Investigative Site

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (1)

• Alavi A, Hamzavi I, Brown K, Santos LL, Zhu Z, Liu H, Howell MD, Kirby JS. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies. Br J Dermatol. 2022 May;186(5):803-813. doi: 10.1111/bjd.20969. Epub 2022 Mar 6.

  PMID: 34978076 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Incyte Corporation Call Center
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 31, 2018
• Study Start: October 15, 2018
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: August 21, 2025
• Results First Posted: September 21, 2020

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9); DE (2); DK (2)