A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
A legfontosabb adatok
- Hol
- Albuquerque, Arkansas City, Baltimore, Bellaire, Beverly, Bexley, Boardman, Boca Raton, Boston, Bowling Green, Brighton, Chicago, Cincinnati, Cleveland, Columbia, Fort Smith, Hialeah, Indianapolis, Kew Gardens, Laguna Niguel, Los Angeles, Margate, Marietta, Metairie, Norfolk, North Miami Beach, Orlando, Phoenix, Plano, Portland, San Francisco, Skokie, Spokane, St Louis és Tampa (Egyesült Államok)Mind a 37 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Albuquerque, New MexicoHospital not named in the registryNo longer taking part
- Arkansas City, ArkansasHospital 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
- Boardman, OhioHospital not named in the registryNo longer taking part
- Boca Raton, FloridaHospital not named in the registryNo longer taking part
- Boca Raton, FloridaHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Bowling Green, KentuckyHospital not named in the registryNo longer taking part
- Brighton, MassachusettsHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cincinnati, OhioHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Columbia, MarylandHospital not named in the registryNo longer taking part
- Fort Smith, ArkansasHospital not named in the registryNo longer taking part
- Hialeah, FloridaHospital not named in the registryNo longer taking part
- Indianapolis, IndianaHospital not named in the registryNo longer taking part
- Kew Gardens, New YorkHospital not named in the registryNo longer taking part
- Laguna Niguel, CaliforniaHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Margate, FloridaHospital not named in the registryNo longer taking part
- Marietta, GeorgiaHospital not named in the registryNo longer taking part
- Metairie, LouisianaHospital not named in the registryNo longer taking part
- Norfolk, VirginiaHospital not named in the registryNo longer taking part
- North Miami Beach, FloridaHospital not named in the registryNo longer taking part
- Orlando, FloridaHospital not named in the registryNo longer taking part
- Phoenix, ArizonaHospital not named in the registryNo longer taking part
- Plano, TexasHospital not named in the registryNo longer taking part
- Portland, OregonHospital not named in the registryNo longer taking part
- San Francisco, CaliforniaHospital not named in the registryNo longer taking part
- Skokie, IllinoisHospital not named in the registryNo longer taking part
- Spokane, WashingtonHospital not named in the registryNo longer taking part
- St Louis, MissouriHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- Incyte Corporation
- Azonosító
- NCT05620823EU 2022-501752-29-00
- A regiszteradat frissítve
- 2026. február 10.
- 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: Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit; Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits; HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits; Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS); Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period; Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed; Agreement to use contraception; Willing and able to comply with the study protocol and procedures; Further inclusion criteria apply.
Kizáró feltételek: Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator; Laboratory values outside of the protocol-defined ranges; Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit; Women who are pregnant (or who are considering pregnancy) or breastfeeding; Further exclusion criteria apply.