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INCB054707

Phase 3

Hidradenitis Suppurativa | Small molecule | Dermatology |Incyte Corporation|Trials Updated: Oct 9, 2026

INCB054707 development status

Highest phase Phase 3 (NCT06855498)
Phase scored for INCYPhase 2
Registered trials 24 across 2 sponsors since Jun 2018

INCB054707 target and mechanism

Molecular targetJanus kinase 1
Target classKinase
ModalitySmall molecule

Also known as Povorcitinib

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials18
Total Enrollment5,118

FDA Designations

No designations recorded

INCB054707 clinical trials

INCB054707 · 18 trials · 14 indications

Phase 3 8Phase 2 8Phase 1 2
NCT06855498Rollover Study for Participants Previously Enrolled in Clinical Trials of PovorcitinibHidradenitis Suppurativa (HS)
RECRUITING600 Analytics
NCT06516952A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)Prurigo Nodularis
ACTIVE NOT_RECRUITING349 Analytics
NCT06516965A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)Prurigo Nodularis
ACTIVE NOT_RECRUITING346 Analytics
NCT06212999A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa (HS)
ACTIVE NOT_RECRUITING617 Analytics
NCT06113445A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)NonSegmental Vitiligo
ACTIVE NOT_RECRUITING467 Analytics
NCT06113471A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)NonSegmental Vitiligo
ACTIVE NOT_RECRUITING450 Analytics
NCT05620836A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)Hidradenitis Suppurativa (HS)
COMPLETED619 Analytics
NCT05620823A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa (HS)
COMPLETED608 Analytics
PHASE3RECRUITING
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)Unlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
Prurigo NodularisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
Prurigo NodularisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)Unlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
NonSegmental VitiligoUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
NonSegmental VitiligoUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (HS)Unlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 3 years

Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.

Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
Week 24

Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS).

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Week 52

≥75% improvement in facial Vitiligo Area Scoring Index.

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Week 12

HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

Apparent clearance
Up to Week 24
Apparent volume of distribution
Up to Week 24
Apparent oral absorption rate constant
Up to Week 24
Absorption lag time
Up to Week 24
Maximum plasma drug concentration at steady state
Up to Week 24
Average plasma drug concentration at steady state
Up to Week 24
Plasma concentration at steady state for the dosing interval
Up to Week 24
Time to maximum plasma concentration at steady state
Up to Week 24
Terminal half-life
Up to Week 24
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
Baseline; Week 12

The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.

Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
Baseline ; Week 24

To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24

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

Secondary Endpoints

Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
Up to approximately 3 years
Proportion of participants achieving Itch NRS4 at Week 24
Week 24
Proportion of participants achieving IGA-CPG-S-TS at Week 24
Week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
povorcitinibEXPERIMENTALParticipants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.
Povorcitinib Dose 1EXPERIMENTALPovorcitinib at the protocol-defined dose.
Povorcitinib Dose 2EXPERIMENTALPovorcitinib at the protocol-defined dose.
PlaceboPLACEBO_COMPARATORPlacebo at the protocol-defined dose.
Cohort AEXPERIMENTALPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Cohort BEXPERIMENTALPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Cohort CEXPERIMENTALPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Experimental: Povorcitinib Dose AEXPERIMENTALParticipants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Povorcitinib Dose AEXPERIMENTALParticipants will receive Povorcitinib Dose A for 54 weeks.
Povorcitinib Dose BEXPERIMENTALParticipants will receive Povorcitinib Dose B for 54 weeks.
Povorcitinib Dose CEXPERIMENTALParticipants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Placebo followed by Povorcitinib Dose A, B, or CEXPERIMENTALParticipants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placeboPLACEBO_COMPARATORParticipants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks
ICS-LABA + povorcitinib Dose 1EXPERIMENTALParticipants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
ICS-LABA + povorcitinib Dose 2EXPERIMENTALParticipants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
ICS-LABA + povorcitinib Dose 3EXPERIMENTALParticipants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
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.

Interventions

NameTypeDescription
povorcitinibDRUGStudy drug will be taken orally as defined by the protocol.
PlaceboDRUGOral Tablet
ICS-LABADRUGBackground Therapy
INCB054707DRUGOral; Tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites296

Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment. * Received clinical benefit from ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBulgariaCanadaChileCzechiaFranceGermanyGreeceHungaryItalyNetherlandsPolandSouth KoreaSpainSwitzerlandUnited KingdomJapanDenmarkMexicoPuerto Rico
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Recent Changes (Last 90 Days)

LOWOct 9, 2026NCT06855498lastUpdatePostDate: changed
LOWOct 9, 2026NCT07213973lastUpdatePostDate: changed
LOWOct 9, 2026NCT06855498lastUpdatePostDate: changed
LOWOct 9, 2026NCT07213973lastUpdatePostDate: changed
LOWSep 16, 2026NCT06855498lastUpdatePostDate: changed
LOWSep 16, 2026NCT06855498lastUpdatePostDate: changed
LOWSep 16, 2026NCT06855498lastUpdatePostDate: changed
LOWSep 16, 2026NCT06855498lastUpdatePostDate: changed
LOWAug 25, 2026NCT06113445lastUpdatePostDate: changed
LOWAug 25, 2026NCT06212999lastUpdatePostDate: changed
LOWAug 25, 2026NCT06113445lastUpdatePostDate: changed
LOWAug 25, 2026NCT06212999lastUpdatePostDate: changed
LOWAug 6, 2026NCT06855498lastUpdatePostDate: changed
LOWAug 6, 2026NCT07213973lastUpdatePostDate: changed
LOWAug 6, 2026NCT06855498lastUpdatePostDate: changed
LOWAug 6, 2026NCT07213973lastUpdatePostDate: changed
LOWJul 24, 2026NCT06855498lastUpdatePostDate: changed
LOWJul 24, 2026NCT07213973lastUpdatePostDate: changed
LOWJul 24, 2026NCT06855498lastUpdatePostDate: changed
LOWJul 24, 2026NCT07213973lastUpdatePostDate: changed

Frequently asked questions about INCB054707

What is INCB054707?

INCB054707 is an investigational small molecule developed by Incyte Corporation for dermatologic conditions. It is being studied in hidradenitis suppurativa, nonsegmental vitiligo, prurigo nodularis, and renal insufficiency. The drug is in Phase 2 clinical development and has not been approved by the FDA.

What does INCB054707 target?

INCB054707 targets Janus kinase 1, a kinase enzyme involved in inflammatory signaling. By inhibiting JAK1, the drug aims to modulate immune pathways associated with skin and inflammatory diseases. This mechanism is being explored in conditions such as vitiligo and prurigo nodularis.

Who is developing INCB054707?

INCB054707 is being developed by Incyte Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker INCY. Incyte is responsible for the clinical development of the drug across multiple dermatologic indications.

What phase is INCB054707 in?

INCB054707 is in Phase 2 clinical development. It has completed three trials, including two Phase 1 studies and two Phase 2 studies, with a total enrollment of 254 participants. The drug remains investigational and has not been approved for any indication.

What clinical trials is INCB054707 in?

INCB054707 has been evaluated in completed trials including NCT05061693, a Phase 2 study in prurigo nodularis with 146 participants, and NCT04818346, a Phase 2 study in nonsegmental vitiligo with 171 participants. Phase 1 trials NCT05624723 and NCT05624710 assessed pharmacokinetics in renal and hepatic impairment.