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Janus Kinase (JAK) Inhibitor

INCB054707 for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, 6, 8, 12, and 16 for reporting.

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 more

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03569371

30%

Upper respiratory tract infection

10%

Nausea

10%

Headache

10%

Fibromyalgia

10%

Anxiety

10%

Rash

10%

Night sweats

100%

80%

60%

40%

20%

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

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