A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
A legfontosabb adatok
- Hol
- Arkansas City, Arlington, Baltimore, Bellaire, Beverly, Bexley, Brandon, Chapel Hill, Columbus, Detroit, Fayetteville, Hightstown, Indianapolis, Iowa City, Los Angeles, Louisville, Margate, Metairie, Miami, Minneapolis, Murfreesboro, New Orleans, New York, Ocala, Omaha, Pflugerville, Quincy, Rochester, San Antonio, San Diego, San Francisco, Scottsdale, Tampa, Washington D.C., Waterford és West Dundee (Egyesült Államok)Mind a 38 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Arkansas City, ArkansasHospital not named in the registryNo longer taking part
- Arlington, TexasHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Bellaire, TexasHospital not named in the registryNo longer taking part
- Beverly, MassachusettsHospital not named in the registryNo longer taking part
- Bexley, OhioHospital not named in the registryNo longer taking part
- Brandon, FloridaHospital not named in the registryNo longer taking part
- Chapel Hill, North CarolinaHospital not named in the registryNo longer taking part
- Columbus, OhioHospital not named in the registryNo longer taking part
- Detroit, MichiganHospital not named in the registryNo longer taking part
- Fayetteville, ArkansasHospital not named in the registryNo longer taking part
- Hightstown, New JerseyHospital not named in the registryNo longer taking part
- Indianapolis, IndianaHospital not named in the registryNo longer taking part
- Iowa City, IowaHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Louisville, KentuckyHospital not named in the registryNo longer taking part
- Margate, FloridaHospital not named in the registryNo longer taking part
- Metairie, LouisianaHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Minneapolis, MinnesotaHospital not named in the registryNo longer taking part
- Murfreesboro, TennesseeHospital not named in the registryNo longer taking part
- New Orleans, LouisianaHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Ocala, FloridaHospital not named in the registryNo longer taking part
- Omaha, NebraskaHospital not named in the registryNo longer taking part
- Pflugerville, TexasHospital not named in the registryNo longer taking part
- Quincy, MassachusettsHospital not named in the registryNo longer taking part
- Rochester, New YorkHospital not named in the registryNo longer taking part
- San Antonio, TexasHospital not named in the registryNo longer taking part
- San Diego, CaliforniaHospital not named in the registryNo longer taking part
- San Francisco, CaliforniaHospital not named in the registryNo longer taking part
- Scottsdale, ArizonaHospital not named in the registryNo longer taking part
- Scottsdale, ArizonaHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
- Waterford, MichiganHospital not named in the registryNo longer taking part
- West Dundee, IllinoisHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- Incyte Corporation
- Azonosító
- NCT05620836EU 2022-501753-36-00
- A regiszteradat frissítve
- 2026. november 5.
- Eredeti leírás
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.A teljes eredeti leírásKevesebb
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.
Bevonási feltételek: Male and female participants ≥ 18 years of age; Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit; HS lesions present in ≥ 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits; Total abscess and inflammatory nodule (AN) count ≥ 5 at both the Screening and Baseline visits; History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS); Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period; Willingness to avoid pregnancy or fathering children; Other inclusion criteria apply.
Kizáró feltételek: Evidence of infection with TB, HBV, HCV or HIV; History of failure to JAK inhibitor treatment of any inflammatory disease; Draining tunnel count of > 20 at Screening or Baseline visits; Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies; Laboratory values outside of the protocol-defined ranges; Women who are pregnant (or who are considering pregnancy) or breastfeeding; Other exclusion criteria apply.