Phase 2
N=10
A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT03569371 ↗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
| Outcome | Result | p-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.
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.