A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
NCT ID: NCT03607487
Last Updated: 2025-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2018-10-15
2019-08-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
NCT03569371
Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa
NCT00795574
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT03487276
Hidradenitis Suppurativa Phase 2b Study of Izokibep
NCT05355805
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06411379
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
INCB054707 at the Cohort 1 dose or placebo.
INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Placebo
Placebo tablet administered orally once daily.
Cohort 2
INCB054707 at the Cohort 2 dose or placebo.
INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Placebo
Placebo tablet administered orally once daily.
Cohort 3
INCB054707 at the Cohort 3 dose or placebo.
INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Placebo
Placebo tablet administered orally once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Placebo
Placebo tablet administered orally once daily.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathleen Butler, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative Site
Winnipeg, Manitoba, Canada
Investigative Site
Fredericton, New Brunswick, Canada
Investigative Site
Barrie, Ontario, Canada
Investigative Site
London, Ontario, Canada
Investigative Site 009
Markham, Ontario, Canada
Investigative Site 008
Richmond Hill, Ontario, Canada
Investigative Site 007
Windsor, Ontario, Canada
Investigative Site
Drummondville, Quebec, Canada
Investigative Site
Saint-Jérôme, Quebec, Canada
Investigative Site
Aarhus, , Denmark
Investigative Site
Roskilde, , Denmark
Investigative Site
Bochum, Noth Rhine-Westphalia, Germany
Investigative Site
Lübeck, Schleswig-Holstein, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-000827-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 54707-203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.