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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
Awards & highlights

Study Summary

This trial will test a new drug for hidradenitis suppurativa, a skin condition, over 16 weeks. There will be a placebo group and an open-label extension period for those who improve.

Eligible Conditions
  • Hidradenitis Suppurativa

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Secondary outcome measures
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%
Rash
10%
Night sweats
10%
Nausea
10%
Fibromyalgia
10%
Headache
10%
Anxiety
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
~530

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,956 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
2,298 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are older individuals permitted to participate in this experimental research?

"The age range for the participants of this research is between 18 to 75, with 3 studies exclusive to minors and 35 specifically curated for seniors."

Answered by AI

Are investigators currently seeking participants for this clinical research?

"The recruitment phase of this medical trial has ended, as the last update on clinicaltrials.gov was dated September 14th 2022. Despite that, there are 37 other studies currently accepting patients for enrolment."

Answered by AI

Has the FDA given their stamp of approval for INCB054707?

"INCB054707's safety was rated with a score of 2. Although there is some evidence of its security, no data exists to confirm the efficacy of this drug yet."

Answered by AI

Who qualifies as a suitable participant for this trial?

"This scientific trial is looking to enrol 209 individuals, aged between 18 and 75 who are currently suffering from acne inversa. In addition, they must have active HS present across two distinct parts of the body, a minimum 3 month history with this condition prior to screening as well as abstain from pregnancy or fathering children during the placebo-controlled 16 week treatment period. Finally, participants agree not to use topical antiseptics on their affected areas while partaking in this study."

Answered by AI

How widely is this trial distributed across various sites?

"Patients are being enrolled at Investigative Site 021 in Miami, Florida, Investigative Site 006 in Tampa, Missouri and Investigative Site 017 in Winston-Salem, California as well as 27 other trial sites."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Investigative Site 017
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I need help managing my HS.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
2020. "To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04476043.
~46 spots leftby Apr 2025
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