Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Povorcitinib
INCB054707 · 18 trials · 14 indications
Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.
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).
≥75% improvement in facial Vitiligo Area Scoring Index.
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.
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.
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
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.
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.
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.
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".
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.
Defined as maximum observed plasma concentration of INCB054707
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Defined as under the concentration-time curve up to the last measurable concentration of INCB054707
Defined as maximum observed plasma concentration of INCB054707
Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.
Defined as area under the concentration-time curve From 0 to Infinity of INCB054707
| Arm | Type | Description |
|---|---|---|
| povorcitinib | EXPERIMENTAL | Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled. |
| Povorcitinib Dose 1 | EXPERIMENTAL | Povorcitinib at the protocol-defined dose. |
| Povorcitinib Dose 2 | EXPERIMENTAL | Povorcitinib at the protocol-defined dose. |
| Placebo | PLACEBO_COMPARATOR | Placebo at the protocol-defined dose. |
| Cohort A | EXPERIMENTAL | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
| Cohort B | EXPERIMENTAL | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
| Cohort C | EXPERIMENTAL | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
| Experimental: Povorcitinib Dose A | EXPERIMENTAL | Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. |
| Povorcitinib Dose A | EXPERIMENTAL | Participants will receive Povorcitinib Dose A for 54 weeks. |
| Povorcitinib Dose B | EXPERIMENTAL | Participants will receive Povorcitinib Dose B for 54 weeks. |
| Povorcitinib Dose C | EXPERIMENTAL | Participants 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 C | EXPERIMENTAL | Participants 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) + placebo | PLACEBO_COMPARATOR | Participants 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 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants 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 A | EXPERIMENTAL | Participants 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 B | EXPERIMENTAL | Participants 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 C | EXPERIMENTAL | Participants 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 C | PLACEBO_COMPARATOR | Participants 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 C | EXPERIMENTAL | Participants 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 C | PLACEBO_COMPARATOR | Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). |
| INCB054707 15 mg | EXPERIMENTAL | 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. |
| INCB054707 45 mg | EXPERIMENTAL | 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. |
| INCB054707 75 mg | EXPERIMENTAL | 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. |
| Placebo followed by INCB054707 75 mg | PLACEBO_COMPARATOR | 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. |
| Cohort 1 | EXPERIMENTAL | INCB054707 at the Cohort 1 dose or placebo. |
| Cohort 2 | EXPERIMENTAL | INCB054707 at the Cohort 2 dose or placebo. |
| Cohort 3 | EXPERIMENTAL | INCB054707 at the Cohort 3 dose or placebo. |
| INCB054707 | EXPERIMENTAL | - |
| Group 1: Normal Renal Function | EXPERIMENTAL | Participants with normal levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. |
| Group 2: Mild Renal Impairment | EXPERIMENTAL | Participants with mild levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. |
| Group 3: Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. |
| Group 4: Severe Renal Impairment | EXPERIMENTAL | Participants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. |
| Group 5: Kidney Failure | EXPERIMENTAL | Group 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 Impairment | EXPERIMENTAL | Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
| Group 2: Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
| Group 3: Mild Hepatic Impairment | EXPERIMENTAL | Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
| Group D: Normal Hepatic Function | EXPERIMENTAL | Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1. |
| Name | Type | Description |
|---|---|---|
| povorcitinib | DRUG | Study drug will be taken orally as defined by the protocol. |
| Placebo | DRUG | Oral Tablet |
| ICS-LABA | DRUG | Background Therapy |
| INCB054707 | DRUG | Oral; Tablet |
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 ...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
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.
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.
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.
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.
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.