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Janus Kinase (JAK) Inhibitor
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 4, 6, 8, 12, and 16
Summary
This trial is testing a new medication called INCB054707 to help people with hidradenitis suppurativa, a painful skin condition. The study will first compare the medication to an inactive substance for a few months, then allow all participants to use the medication for several more months. If effective, participants can continue using it for an extended period.
Eligible Conditions
- Hidradenitis Suppurativa
- Hidradenitis suppurativa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 2, 4, 6, 8, 12, and 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 4, 6, 8, 12, and 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Secondary study objectives
Mean Change From Baseline in AN Count at Weeks 2 to 12
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
+7 moreSide effects data
From 2019 Phase 2 trial • 10 Patients • NCT0356937130%
Upper respiratory tract infection
10%
Nausea
10%
Headache
10%
Fibromyalgia
10%
Anxiety
10%
Rash
10%
Night sweats
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB054707
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: INCB054707 75 mgExperimental Treatment1 Intervention
Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.
Group II: INCB054707 45 mgExperimental Treatment1 Intervention
Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
Group III: INCB054707 15 mgExperimental Treatment1 Intervention
Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
Group IV: Placebo followed by INCB054707 75 mgPlacebo Group1 Intervention
Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~670
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
392 Previous Clinical Trials
63,732 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
2,317 Patients Enrolled for Hidradenitis Suppurativa