Befejeződött2. fázis
Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
A legfontosabb adatok
- Ki végzi
- Incyte Corporation
- Hol
- Baton Rouge, Boca Raton, Boston, Fountain Valley, Marietta, Murfreesboro, New Orleans, New York, Pflugerville, Phoenix, Plymouth Meeting, San Antonio, Spokane, Tampa és Troy (Egyesült Államok)Mind a 15 helyszín megnézéseMég 1 másik országban, 5 helyszínen
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 2. fázis
- Résztvevők
- 69 fő vett részt
- Kezdés
- 2022. dec. 7.
- Befejezés
- 2024. márc. 14.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Ruxolitinib cream
- Vehicle cream
- A regiszteradat frissítve
- 2024. november 1.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- Diagnosis of HS based on clinical history and physical examination for at least 3 months
- Diagnosis of HS (Hurley I or II) with the following:; A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND; The AN count at the screening AND baseline visits:
- AN of 3 should affect at least 1 distinct anatomical area
- AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas
- Baseline Skin Pain or Itch NRS score ≥ 1
- Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study
- Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study
- Willingness to avoid pregnancy or fathering children
Ki nem vehet részt
- Use of any prohibited medications per protocol-defined criteria
- Concurrent conditions and history of other diseases:; Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS; Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety; Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome); Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline; Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline
- Laboratory values outside of the protocol-defined criteria
- Presence of draining tunnels at screening or at baseline visits
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation
- Other exclusion criteria may apply
Helyszínek itt: Egyesült Államok
Még 1 másik országban, 5 helyszínen
- DelRicht ResearchBaton Rouge, Egyesült ÁllamokNo longer taking part
- Skin Care Research, Llc Scr HollywoodBoca Raton, Egyesült ÁllamokNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- First OC DermatologyFountain Valley, Egyesült ÁllamokNo longer taking part
- Marietta Dermatology & The Skin Cancer Center - MariettaMarietta, Egyesült ÁllamokNo longer taking part
- International Clinical Research - Tennessee LLCMurfreesboro, Egyesült ÁllamokNo longer taking part
- Delricht ResearchNew Orleans, Egyesült ÁllamokNo longer taking part
- Dr Bobby Buka, Md Greenwich VillageNew York, Egyesült ÁllamokNo longer taking part
- Austin Institute For Clinical Research Aicr PflugervillePflugerville, Egyesült ÁllamokNo longer taking part
- Medical Dermatology Specialists PhoenixPhoenix, Egyesült ÁllamokNo longer taking part
- Dermatology Associates of Plymouth MeetingPlymouth Meeting, Egyesült ÁllamokNo longer taking part
- Progressive Clinical ResearchSan Antonio, Egyesült ÁllamokNo longer taking part
- Dermatology Specialists of SpokaneSpokane, Egyesült ÁllamokNo longer taking part
- ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Revival Research Institute, Llc TroyTroy, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.
A vizsgálat 2 csoportja
- Ruxolitinib CreamA vizsgált kezelés
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
- Vehicle CreamA vizsgált kezelés
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
- A regiszteradat frissítve
- 2024. november 1.