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Phase 2 N=10 Treatment

A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Hidradenitis Suppurativa

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 7 Participants

Study Design & Population

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
7
SECONDARY
Apparent Oral Clearance of INCB054707(CL/F)
5.07
SECONDARY
Apparent Oral Volume of Distribution of INCB054707(Vc/F)
227
SECONDARY
Absorption Constant of INCB054707 (Ka)
0.257
SECONDARY
Apparent Inter-compartmental Clearance(Q/F)
16.2
SECONDARY
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
1; 3; 3; 2; 3; 4
SECONDARY
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
0; 2; 4; 4; 2; 3
SECONDARY
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
-1.5; -3.2; -2.6; -3.2; -2.0; -1.8
SECONDARY
Mean Change From Baseline in the Modified Sartorius Scale Score
-13.6
SECONDARY
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
-0.1; 0.2; 0.6; 1.9; 0.1; 0.7
SECONDARY
Proportion of Participants at Each Category of Hurley Stage
0; 7; 3; 0; 0; 5
SECONDARY
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
0; 0; 7; 3; 1; 0
SECONDARY
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
0; 0; 3; 5; 2; 0
SECONDARY
Proportion of Participants Requiring Rescue Lesional Treatment
1; 9; 0; 9; 0; 9
SECONDARY
Number of Interventions With Rescue Lesional Treatment
0.1; 0; 0; 0; 0.1; 0
SECONDARY
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
0; 1; 3; 2; 4; 0

Summary

The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).

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 III at screening and baseline.
  • Total AN count of at least 3 at screening and baseline.
  • Male participants must agree to use contraception per protocol-defined criteria.

Exclusion Criteria

  • Women of childbearing potential or who are currently pregnant or lactating.
  • Presence of > 20 draining fistulas at screening and baseline.
  • Participants with concurrent conditions or history of other diseases as follows:
  • Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
  • Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
  • Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the study.
  • Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
  • History of malignancy, including lymphoma and leukemia within 5 years before baseline, other than a successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
  • Albinism.
  • Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
  • Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of 1.5 mg/dL.
  • Use of prohibited medications per protocol-defined criteria.
  • 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 prior to baseline.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03569371). 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.

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