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INCB054707

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Incyte Corporation|Last Updated: Aug 21, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment254

FDA Designations

No designations recorded

Clinical trial landscape

INCB054707 · 8 trials · 7 indications

Phase 2 5Phase 1 3
NCT05061693A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo NodularisPrurigo Nodularis
COMPLETED146 Analytics
NCT04818346A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With VitiligoNonSegmental Vitiligo
COMPLETED171 Analytics
NCT04476043To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED209 Analytics
NCT03607487A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED35 Analytics
NCT03569371A Study of the Safety of INCB054707 in Participants With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED10 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Prurigo NodularisUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
NonSegmental VitiligoUnlock trial analytics
PHASE2COMPLETED
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics
PHASE2COMPLETED
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics
PHASE2COMPLETED
A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16
Baseline; Week 16

Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.

Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
Baseline; Week 24

The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area \[BSA\]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.

Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Baseline; Week 16

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.

Number of Treatment-emergent Adverse Events (TEAEs)
Up to 12 weeks

TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to approximately 12 weeks.

A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Pharmacokinetics Parameter: Cmax of INCB054707
Days 1-4

Defined as maximum observed plasma concentration of INCB054707

Pharmacokinetics Parameter: AUC0-t of INCB054707
Days 1-4

Area Under the concentration- time curve up to the last measurable concentration of INCB054707

Pharmacokinetics Parameter: AUC0-∞ of INCB54707
Days 1-4

Defined as under the concentration-time curve up to the last measurable concentration of INCB054707

Pharmacokinetics Parameter: Cmax of INCBC054707
Days 1 - 5

Defined as maximum observed plasma concentration of INCB054707

Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Days 1 - 5

Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.

Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Days 1 - 5

Defined as area under the concentration-time curve From 0 to Infinity of INCB054707

Number of participants with Treatment Emergent Adverse Events (TEAE'S)
3 months

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Pharmacokinetics Parameter : Cmax of INCB054707
17 Days

Maximum Observed Plasma Concentration of INCB054707

Pharmacokinetics Parameter : Cmin of INCB054707
17 Days

Minimum Observed Plasma Concentration of INCB054707

Pharmacokinetics Parameter : tmax of INCB054707
17 Days

Time to reach maximum plasma concentration of INCB054707

Pharmacokinetics Parameter : AUC(0-t) of INCB054707
17 Days

Area Under the concentration- time curve up to the last measurable concentration of INCB054707

Pharmacokinetics Parameter : AUC(0-∞) of INCB054707
17 Days

Area Under the Concentration-time Curve From 0 to Infinity of INCB054707

Pharmacokinetics Parameter : AUC(0-tau) of INCB054707
17 Days

Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707

Secondary Endpoints

Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16
Baseline; Week 16
Time to ≥4-point Improvement From Baseline in Itch NRS Score
up to 122 days
PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
up to 152 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB054707 Dose AEXPERIMENTALParticipants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
INCB054707 Dose BEXPERIMENTALParticipants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
INCB054707 Dose CEXPERIMENTALParticipants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Placebo followed by INCB054707 Dose B or CPLACEBO_COMPARATORParticipants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
INCB054707 Dose A followed by Dose CEXPERIMENTALParticipants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
Placebo followed by INCB054707 Dose CPLACEBO_COMPARATORParticipants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
INCB054707 15 mgEXPERIMENTALParticipants 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.
INCB054707 45 mgEXPERIMENTALParticipants 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.
INCB054707 75 mgEXPERIMENTALParticipants 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.
Placebo followed by INCB054707 75 mgPLACEBO_COMPARATORParticipants 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.
Cohort 1EXPERIMENTALINCB054707 at the Cohort 1 dose or placebo.
Cohort 2EXPERIMENTALINCB054707 at the Cohort 2 dose or placebo.
Cohort 3EXPERIMENTALINCB054707 at the Cohort 3 dose or placebo.
INCB054707EXPERIMENTAL -
Group 1: Normal Renal FunctionEXPERIMENTALParticipants with normal levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 2: Mild Renal ImpairmentEXPERIMENTALParticipants with mild levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 3: Moderate Renal ImpairmentEXPERIMENTALParticipants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 4: Severe Renal ImpairmentEXPERIMENTALParticipants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 5: Kidney FailureEXPERIMENTALGroup 5 participants with ESRD maintained on HD will receive a single dose of INCB054707 across 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB054707.
Group 1: Severe Hepatic ImpairmentEXPERIMENTALParticipants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Group 2: Moderate Hepatic ImpairmentEXPERIMENTALParticipants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Group 3: Mild Hepatic ImpairmentEXPERIMENTALParticipants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Group D: Normal Hepatic FunctionEXPERIMENTALParticipants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1.
INCB054707 (Dose A)EXPERIMENTALParticipants will be administered single-dose INCB054707 on Day 1 followed by once daily dose of INCB054707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours
INCB054707 (Dose B)EXPERIMENTALParticipants will be administered a single-dose INCB054707 on Day 1 followed by once daily dose of INCB54707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours.
Placebo (Dose A)PLACEBO_COMPARATORParticipants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours
Placebo (Dose B)PLACEBO_COMPARATORParticipants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours

Interventions

NameTypeDescription
INCB054707DRUGOral; Tablet
PlaceboDRUGOral; Tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Clinical diagnosis of PN for at least 3 months before screening. * Inadequate response or intolerant to ongoing or prior PN therapy. * ≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day 1. * Willingness to avoid pregnancy or fathering children * Furthe...

Countries:United StatesCanadaGermanyPolandPuerto RicoSpainFranceDenmarkJapan
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Frequently asked questions about INCB054707

What is INCB054707 used for?

INCB054707 is an investigational small molecule being studied for hidradenitis suppurativa, renal insufficiency, nonsegmental vitiligo, prurigo nodularis, and in healthy participants. It is being developed by Incyte Corporation and is currently in Phase 1 clinical development.

Who makes INCB054707?

INCB054707 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker INCY. The drug is an investigational small molecule and has not been approved by regulatory authorities.

What phase is INCB054707 in?

INCB054707 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Clinical trials for the drug are ongoing to evaluate its safety and efficacy.

What clinical trials is INCB054707 in?

INCB054707 has completed several Phase 2 trials, including NCT03569371 and NCT03607487 in hidradenitis suppurativa, NCT04476043 in hidradenitis suppurativa and acne inversa, and NCT04818346 in nonsegmental vitiligo. These trials were placebo-controlled and double-blind.

Is INCB054707 the same as any other drug?

INCB054707 is a distinct investigational compound developed by Incyte Corporation. It is not known to be the same as any other marketed drug. Its mechanism of action has not been publicly disclosed in the available clinical trial information.