Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04476043 | To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa | PHASE2 | COMPLETED | 209 | — | — | Aug 25, 2020 | Aug 16, 2023 | Aug 12, 2025 | 40 | United States, Canada +4 |
| NCT03607487 | A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa | PHASE2 | COMPLETED | 35 | — | — | Oct 15, 2018 | Aug 13, 2019 | Aug 21, 2025 | 13 | Canada, Denmark +1 |
| NCT03569371 | A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa | PHASE2 | COMPLETED | 10 | — | — | Jul 17, 2018 | Apr 22, 2019 | Sep 26, 2022 | 4 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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 | - |
| Name | Type | Description |
|---|---|---|
| INCB054707 | DRUG | Oral; Tablet |
| Placebo | DRUG | Oral; Tablet |
Inclusion Criteria: * HS disease duration of at least 3 months before screening. * Willingness to avoid pregnancy or fathering children. * Active HS in at least 2 distinct anatomical areas. * Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-co...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Lutikizumab, Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib, povorcitinib, Ruxolitinib, Vehicle |
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | secukinumab, Remibrutinib Dose A, Remibrutinib Dose B, CFZ533, LYS006 |
| MoonLake Immunotherapeutics Class A | MLTX | 4 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig, SAR445399 |
| Insmed Incorporated | INSM | 1 | PHASE2 | Brensocatib |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Eltrekibart |
| 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 |