Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB054707 · 8 trials · 7 indications
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
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Maximum Observed Plasma Concentration of INCB054707
Minimum Observed Plasma Concentration of INCB054707
Time to reach maximum plasma concentration of INCB054707
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707
| Arm | Type | Description |
|---|---|---|
| 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. |
| INCB054707 (Dose A) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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_COMPARATOR | Participants 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_COMPARATOR | Participants 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 |
| Name | Type | Description |
|---|---|---|
| INCB054707 | DRUG | Oral; Tablet |
| Placebo | DRUG | Oral; Tablet |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib |
| Novartis AG Sponsored ADR | NVS | 11 | PHASE3 | Remibrutinib Dose A, Remibrutinib Dose B |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig |
| 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 Dose A, Tibulizumab Dose B |
| Sonoma Pharmaceuticals, Inc. | SNOA | 2 | PHASE1 | SBT777101 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
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.
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.
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.
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.
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.