Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
- Registration Number
- NCT06855498
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Ability to comprehend and willingness to sign a written ICF for the study.
- Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
- Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
- Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
- Willingness to avoid pregnancy or fathering children as defined in the protocol.
- Willingness and ability to comply with the study Protocol and procedures.
-
Had been permanently discontinued from study treatment during the parent study.
-
Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
-
Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:
- Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
- Live, attenuated vaccine.
-
Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
-
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
-
Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
-
Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
-
Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description povorcitinib povorcitinib Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.
- Primary Outcome Measures
Name Time Method Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) Up to approximately 3 years Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.
- Secondary Outcome Measures
Name Time Method Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit Up to approximately 3 years ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (316)
Investigative Site JP008
🇯🇵Nishihara, Japan
Investigative Site US086
🇺🇸Birmingham, Alabama, United States
Investigative Site US098
🇺🇸Montgomery, Alabama, United States
Investigative Site US004
🇺🇸Phoenix, Arizona, United States
Investigative Site US047
🇺🇸Scottsdale, Arizona, United States
Investigative Site US045
🇺🇸Fort Smith, Arkansas, United States
Investigative Site US009
🇺🇸Rogers, Arkansas, United States
Investigative Site US076
🇺🇸Fountain Valley, California, United States
Investigative Site US077
🇺🇸Fremont, California, United States
Investigative Site US071
🇺🇸Huntington Beach, California, United States
Investigative Site US020
🇺🇸Laguna Niguel, California, United States
Investigative Site US036
🇺🇸Los Angeles, California, United States
Investigative Site US067
🇺🇸Los Angeles, California, United States
Investigative Site US060
🇺🇸Northridge, California, United States
Investigative Site US037
🇺🇸Oakland, California, United States
Investigative Site US032
🇺🇸San Diego, California, United States
Investigative Site US089
🇺🇸Santa Monica, California, United States
Investigative Site US080
🇺🇸Sherman Oaks, California, United States
Investigative Site US002
🇺🇸Boca Raton, Florida, United States
Investigative Site US035
🇺🇸Brandon, Florida, United States
Investigative Site US087
🇺🇸Cape Coral, Florida, United States
Investigative Site US062
🇺🇸Coral Gables, Florida, United States
Investigative Site US084
🇺🇸Coral Gables, Florida, United States
Investigative Site US017
🇺🇸Hialeah, Florida, United States
Investigative Site US019
🇺🇸Hollywood, Florida, United States
Investigative Site US090
🇺🇸Hollywood, Florida, United States
Investigative Site US041
🇺🇸Maitland, Florida, United States
Investigative Site US044
🇺🇸Margate, Florida, United States
Investigative Site US072
🇺🇸Miami Lakes, Florida, United States
Investigative Site US079
🇺🇸Miami Lakes, Florida, United States
Investigative Site US015
🇺🇸Miami, Florida, United States
Investigative Site US023
🇺🇸Miami, Florida, United States
Investigative Site US059
🇺🇸Miami, Florida, United States
Investigative Site US029
🇺🇸Ocala, Florida, United States
Investigative Site US005
🇺🇸Tampa, Florida, United States
Investigative Site US001
🇺🇸Tampa, Florida, United States
Investigative Site US066
🇺🇸West Palm Beach, Florida, United States
Investigative Site US070
🇺🇸West Palm Beach, Florida, United States
Investigative Site US051
🇺🇸Marietta, Georgia, United States
Investigative Site US103
🇺🇸Sandy Springs, Georgia, United States
Investigative Site US100
🇺🇸Stonecrest, Georgia, United States
Investigative Site US093
🇺🇸Chicago, Illinois, United States
Investigative Site US049
🇺🇸Skokie, Illinois, United States
Investigative Site US039
🇺🇸West Dundee, Illinois, United States
Investigative Site US108
🇺🇸Indianapolis, Indiana, United States
Investigative Site US008
🇺🇸Indianapolis, Indiana, United States
Investigative Site US064
🇺🇸West Lafayette, Indiana, United States
Investigative Site US056
🇺🇸Bowling Green, Kentucky, United States
Investigative Site US012
🇺🇸Baton Rouge, Louisiana, United States
Investigative Site US006
🇺🇸Metairie, Louisiana, United States
Investigative Site US057
🇺🇸New Orleans, Louisiana, United States
Investigative Site US038
🇺🇸Baltimore, Maryland, United States
Investigative Site US099
🇺🇸Glenn Dale, Maryland, United States
Investigative Site US053
🇺🇸Marriottsville, Maryland, United States
Investigative Site US101
🇺🇸Rockville, Maryland, United States
Investigative Site US030
🇺🇸Boston, Massachusetts, United States
Investigative Site US048
🇺🇸Needham, Massachusetts, United States
Investigative Site US061
🇺🇸Ann Arbor, Michigan, United States
Investigative Site US014
🇺🇸Fort Gratiot, Michigan, United States
Investigative Site US091
🇺🇸Troy, Michigan, United States
Investigative Site US042
🇺🇸Waterford, Michigan, United States
Investigative Site US011
🇺🇸Minneapolis, Minnesota, United States
Investigative Site US088
🇺🇸Saint Joseph, Missouri, United States
Investigative Site US016
🇺🇸Saint Louis, Missouri, United States
Investigative Site US007
🇺🇸Portsmouth, New Hampshire, United States
Investigative Site US024
🇺🇸East Windsor, New Jersey, United States
Investigative Site US082
🇺🇸East Syracuse, New York, United States
Investigative Site US040
🇺🇸Kew Gardens, New York, United States
Investigative Site US034
🇺🇸New York, New York, United States
Investigative Site US081
🇺🇸New York, New York, United States
Investigative Site US065
🇺🇸New York, New York, United States
Investigative Site US075
🇺🇸New York, New York, United States
Investigative Site US050
🇺🇸Rochester, New York, United States
Investigative Site US031
🇺🇸Chapel Hill, North Carolina, United States
Investigative Site US028
🇺🇸Bexley, Ohio, United States
Investigative Site US055
🇺🇸Boardman, Ohio, United States
Investigative Site US025
🇺🇸Cincinnati, Ohio, United States
Investigative Site US022
🇺🇸Cleveland, Ohio, United States
Investigative Site US073
🇺🇸Columbus, Ohio, United States
Investigative Site US033
🇺🇸Columbus, Ohio, United States
Investigative Site US085
🇺🇸Oklahoma City, Oklahoma, United States
Investigative Site US018
🇺🇸Portland, Oregon, United States
Investigative Site US074
🇺🇸Philadelphia, Pennsylvania, United States
Investigative Site US069
🇺🇸Plymouth Meeting, Pennsylvania, United States
Investigative Site US043
🇺🇸Murfreesboro, Tennessee, United States
Investigative Site US052
🇺🇸Arlington, Texas, United States
Investigative Site US021
🇺🇸Bellaire, Texas, United States
Investigative Site US010
🇺🇸Dallas, Texas, United States
Investigative Site US078
🇺🇸Dallas, Texas, United States
Investigative Site US054
🇺🇸Pflugerville, Texas, United States
Investigative Site US058
🇺🇸San Antonio, Texas, United States
Investigative Site US083
🇺🇸San Antonio, Texas, United States
Investigative Site US068
🇺🇸Webster, Texas, United States
Investigative Site US063
🇺🇸South Jordan, Utah, United States
Investigative Site US027
🇺🇸Norfolk, Virginia, United States
Investigative Site US094
🇺🇸Richmond, Virginia, United States
Investigative Site US092
🇺🇸Seattle, Washington, United States
Investigative Site US003
🇺🇸Spokane, Washington, United States
Investigative Site AR006
🇦🇷Buenos Aires, Argentina
Investigative Site AR005
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Investigative Site AR002
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Investigative Site AR004
🇦🇷Mar Del Plata, Argentina
Investigative Site AR003
🇦🇷Rosario, Argentina
Investigative Site AR001
🇦🇷San Miguel de Tucuman, Argentina
Investigative Site AU003
🇦🇺Kogarah, New South Wales, Australia
Investigative Site AU005
🇦🇺Liverpool, New South Wales, Australia
Investigative Site AU001
🇦🇺Newcastle, New South Wales, Australia
Investigative Site AU007
🇦🇺Wolloongabba, Queensland, Australia
Investigative Site AU006
🇦🇺Woolloongabba, Queensland, Australia
Investigative Site AU004
🇦🇺Carlton, Victoria, Australia
Investigative Site AU002
🇦🇺East Melbourne, Australia
Investigative Site AU008
🇦🇺Fremantle, Australia
Investigative Site AU009
🇦🇺Westmead, Australia
Investigative Site AT002
🇦🇹Graz, Austria
Investigative Site AT004
🇦🇹Innsbruck, Austria
Investigative Site AT001
🇦🇹Vienna, Austria
Investigative Site AT003
🇦🇹Wien, Austria
Investigative Site BE007
🇧🇪Brugge, Belgium
Investigative Site BE002
🇧🇪Brussel, Belgium
Investigative Site BE001
🇧🇪Gent, Belgium
Investigative Site BE004
🇧🇪Gent, Belgium
Investigative Site BE003
🇧🇪Liege, Belgium
Investigative Site BE006
🇧🇪Loverval, Belgium
Investigative Site BE005
🇧🇪Woluwe-saint-lambert, Belgium
Investigative Site BG008
🇧🇬Dupnitsa, Bulgaria
Investigative Site BG012
🇧🇬Pleven, Bulgaria
Investigative Site BG013
🇧🇬Plovdiv, Bulgaria
Investigative Site BG007
🇧🇬Sevlievo, Bulgaria
Investigative Site BG009
🇧🇬Sofia, Bulgaria
Investigative Site BG002
🇧🇬Sofia, Bulgaria
Investigative Site BG006
🇧🇬Sofia, Bulgaria
Investigative Site BG011
🇧🇬Sofia, Bulgaria
Investigative Site BG003
🇧🇬Sofia, Bulgaria
Investigative Site BG001
🇧🇬Sofia, Bulgaria
Investigative Site BG014
🇧🇬Sofia, Bulgaria
Investigative Site BG005
🇧🇬Sofia, Bulgaria
Investigative Site BG004
🇧🇬Stara Zagora, Bulgaria
Investigative Site CA023
🇨🇦Calgary, Alberta, Canada
Investigative Site CA008
🇨🇦Calgary, Alberta, Canada
Investigative Site CA005
🇨🇦Edmonton, Alberta, Canada
Investigative Site CA028
🇨🇦Edmonton, Alberta, Canada
Investigative Site CA027
🇨🇦Edmonton, Alberta, Canada
Investigative Site CA013
🇨🇦Surrey, British Columbia, Canada
Investigative Site CA024
🇨🇦Vancouver, British Columbia, Canada
Investigative Site CA003
🇨🇦Winnipeg, Manitoba, Canada
Investigative Site CA006
🇨🇦Fredericton, New Brunswick, Canada
Investigative Site CA004
🇨🇦Barrie, Ontario, Canada
Investigative Site CA011
🇨🇦Hamilton, Ontario, Canada
Investigative Site CA025
🇨🇦London, Ontario, Canada
Investigative Site CA002
🇨🇦London, Ontario, Canada
Investigative Site CA022
🇨🇦Markham, Ontario, Canada
Investigative Site CA014
🇨🇦Mississauga, Ontario, Canada
Investigative Site CA016
🇨🇦Mississauga, Ontario, Canada
Investigative Site CA001
🇨🇦Peterborough, Ontario, Canada
Investigative Site CA010
🇨🇦Richmond Hill, Ontario, Canada
Investigative Site CA017
🇨🇦Toronto, Ontario, Canada
Investigative Site CA018
🇨🇦Toronto, Ontario, Canada
Investigative Site CA021
🇨🇦Toronto, Ontario, Canada
Investigative Site CA019
🇨🇦Waterloo, Ontario, Canada
Investigative Site CA007
🇨🇦Montreal, Quebec, Canada
Investigative Site CA020
🇨🇦Quebec City, Quebec, Canada
Investigative Site CA026
🇨🇦Quebec City, Quebec, Canada
Investigative Site CA009
🇨🇦Saint-jerome, Quebec, Canada
Investigative Site CA029
🇨🇦Verdun, Quebec, Canada
Investigative Site CA015
🇨🇦Saskatoon, Saskatchewan, Canada
Investigative Site CA012
🇨🇦St. John's, Canada
Investigative Site CL002
🇨🇱LAS Condes Santiago, Chile
Investigative Site CL003
🇨🇱Santiago, Chile
Investigative Site CL001
🇨🇱Valdivia, Chile
Investigative Site CZ002
🇨🇿Ostrava-poruba, Czechia
Investigative Site CZ004
🇨🇿Prague, Czechia
Investigative Site CZ003
🇨🇿Prague, Czechia
Investigative Site CZ001
🇨🇿Prague, Czechia
Investigative Site DK001
🇩🇰Aarhus, Denmark
Investigative Site DK002
🇩🇰Roskilde, Denmark
Investigative Site FR014
🇫🇷Antony, France
Investigative Site FR006
🇫🇷Bordeaux, France
Investigative Site FR004
🇫🇷Brest, France
Investigative Site FR015
🇫🇷Creteil, France
Investigative Site FR002
🇫🇷Dijon, France
Investigative Site FR013
🇫🇷Le Mans, France
Investigative Site FR009
🇫🇷Lyon, France
Investigative Site FR012
🇫🇷Marseille, France
Investigative Site FR016
🇫🇷Mulhouse, France
Investigative Site FR011
🇫🇷Nantes, France
Investigative Site FR008
🇫🇷Nice, France
Investigative Site FR010
🇫🇷Paris, France
Investigative Site FR005
🇫🇷Reims, France
Investigative Site FR018
🇫🇷Romans Sur Isere, France
Investigative Site FR007
🇫🇷Rouen Cedex, France
Investigative Site FR003
🇫🇷Saint Priest En Jarez, France
Investigative Site FR001
🇫🇷Toulouse Cedex 9, France
Investigative Site FR017
🇫🇷Toulouse, France
Investigative Site DE005
🇩🇪Berlin, Germany
Investigative Site DE006
🇩🇪Bochum, Germany
Investigative Site DE013
🇩🇪Darmstadt, Germany
Investigative Site DE019
🇩🇪Darmstadt, Germany
Investigative Site DE004
🇩🇪Dessau-rosslau, Germany
Investigative Site DE012
🇩🇪Dresden, Germany
Investigative Site DE014
🇩🇪Dusseldorf, Germany
Investigative Site DE009
🇩🇪Erlangen, Germany
Investigative Site DE011
🇩🇪Frankfurt Am Main, Germany
Investigative Site DE010
🇩🇪Gottingen, Germany
Investigative Site DE001
🇩🇪Hamburg, Germany
Investigative Site DE002
🇩🇪Hannover, Germany
Investigative Site DE017
🇩🇪Heidelberg, Germany
Investigative Site DE007
🇩🇪Heidelberg, Germany
Investigative Site DE003
🇩🇪Kiel, Germany
Investigative Site DE015
🇩🇪Mainz, Germany
Investigative Site DE008
🇩🇪Merzig, Germany
Investigative Site DE018
🇩🇪Witten, Germany
Investigative Site GR001
🇬🇷Athens, Greece
Investigative Site GR002
🇬🇷Athens, Greece
Investigative Site GR003
🇬🇷Thessaloniki, Greece
Investigative Site HU001
ðŸ‡ðŸ‡ºDebrecen, Hungary
Investigative Site HU002
ðŸ‡ðŸ‡ºSzombathely, Hungary
Investigative Site IT012
🇮🇹Bari, Italy
Investigative Site IT009
🇮🇹Brescia, Italy
Investigative Site IT001
🇮🇹Catania, Italy
Investigative Site IT007
🇮🇹Chieti, Italy
Investigative Site IT010
🇮🇹L'aquila, Italy
Investigative Site IT011
🇮🇹Milano, Italy
Investigative Site IT005
🇮🇹Milan, Italy
Investigative Site IT008
🇮🇹Naples, Italy
Investigative Site IT013
🇮🇹Perugia, Italy
Investigative Site IT002
🇮🇹Rome, Italy
Investigative Site IT003
🇮🇹Rozzano, Italy
Investigative Site IT004
🇮🇹Torrette DI Ancona, Italy
Investigative Site JP013
🇯🇵Bunkyo-ku, Japan
Investigative Site JP021
🇯🇵Hamamatsu-shi, Japan
Investigative Site JP027
🇯🇵Inashiki-gun, Japan
Investigative Site JP002
🇯🇵Itabashi-ku, Japan
Investigative Site JP024
🇯🇵Kamimashiki-gun, Japan
Investigative Site JP025
🇯🇵Kawasaki-shi, Japan
Investigative Site JP019
🇯🇵Kawasaki-shi, Japan
Investigative Site JP023
🇯🇵Kitakyushu, Japan
Investigative Site JP020
🇯🇵Kobe, Japan
Investigative Site JP022
🇯🇵Kobe, Japan
Investigative Site JP017
🇯🇵Koshigaya-shi, Japan
Investigative Site JP006
🇯🇵Kurume, Japan
Investigative Site JP001
🇯🇵Kyoto, Japan
Investigative Site JP016
🇯🇵Nagasaki-shi, Japan
Investigative Site JP012
🇯🇵Nagoya-shi, Japan
Investigative Site JP010
🇯🇵Nankoku-shi, Japan
Investigative Site JP003
🇯🇵Niigata, Japan
Investigative Site JP014
🇯🇵Okayama-shi, Japan
Investigative Site JP028
🇯🇵Ota-ku, Japan
Investigative Site JP029
🇯🇵Sakai, Japan
Investigative Site JP026
🇯🇵Sapporo, Japan
Investigative Site JP007
🇯🇵Sapporo, Japan
Investigative Site JP005
🇯🇵Sendai, Japan
Investigative Site JP009
🇯🇵Shinagawa-ku, Japan
Investigative Site JP004
🇯🇵Shinjuku-ku, Japan
Investigative Site JP011
🇯🇵Suita, Japan
Investigative Site JP030
🇯🇵Tokorozawa-shi, Japan
Investigative Site JP018
🇯🇵Urayasu, Japan
Investigative Site JP015
🇯🇵Yamagata-shi, Japan
Investigative Site KR006
🇰🇷Ansan-si, Korea, Republic of
Investigative Site KR008
🇰🇷Bucheon-si, Korea, Republic of
Investigative Site KR007
🇰🇷Busan, Korea, Republic of
Investigative Site KR003
🇰🇷Incheon, Korea, Republic of
Investigative Site KR004
🇰🇷Jeonju-si, Korea, Republic of
Investigative Site KR002
🇰🇷Seoul, Korea, Republic of
Investigative Site KR005
🇰🇷Seoul, Korea, Republic of
Investigative Site KR001
🇰🇷Yangsan-si, Korea, Republic of
Investigative Site NL005
🇳🇱Amsterdam, Netherlands
Investigative Site NL007
🇳🇱Amsterdam, Netherlands
Investigative Site NL006
🇳🇱Bergen Op Zoom, Netherlands
Investigative Site NL002
🇳🇱Breda, Netherlands
Investigative Site NL003
🇳🇱Groningen, Netherlands
Investigative Site NL001
🇳🇱Rotterdam, Netherlands
Investigative Site NL004
🇳🇱Veldhoven, Netherlands
Investigative Site PL010
🇵🇱Cracov, Poland
Investigative Site PL011
🇵🇱Gdansk, Poland
Investigative Site PL013
🇵🇱Grodzisk Mazowiecki, Poland
Investigative Site PL016
🇵🇱Katowice, Poland
Investigative Site PL002
🇵🇱Lublin, Poland
Investigative Site PL006
🇵🇱Ostrowiec Swietokrzyski, Poland
Investigative Site PL003
🇵🇱Rzeszow, Poland
Investigative Site PL015
🇵🇱Szczecin, Poland
Investigative Site PL012
🇵🇱Warszawa, Poland
Investigative Site PL007
🇵🇱Warszawa, Poland
Investigative Site PL004
🇵🇱Warszawa, Poland
Investigative Site PL009
🇵🇱Warszawa, Poland
Investigative Site PL014
🇵🇱Wroclaw, Poland
Investigative Site PL001
🇵🇱Wroclaw, Poland
Investigative Site PL005
🇵🇱Wroclaw, Poland
Investigative Site PL008
🇵🇱Wroclaw, Poland
Investigative Site ES001
🇪🇸Badalona, Spain
Investigative Site ES010
🇪🇸Barcelona, Spain
Investigative Site ES015
🇪🇸Cordoba, Spain
Investigative Site ES003
🇪🇸Granada, Spain
Investigative Site ES013
🇪🇸Granada, Spain
Investigative Site ES006
🇪🇸Las Palmas de Gran Canaria, Spain
Investigative Site ES014
🇪🇸Madrid, Spain
Investigative Site ES008
🇪🇸Madrid, Spain
Investigative Site ES011
🇪🇸Madrid, Spain
Investigative Site ES012
🇪🇸Madrid, Spain
Investigative Site ES004
🇪🇸Manises, Spain
Investigative Site ES009
🇪🇸Pontevedra, Spain
Investigative Site ES002
🇪🇸Santiago de Compostela, Spain
Investigative Site CH003
🇨ðŸ‡Bern, Switzerland
Investigative Site CH001
🇨ðŸ‡Buochs, Switzerland
Investigative Site CH002
🇨ðŸ‡Zurich, Switzerland
Investigative Site GB003
🇬🇧Birmingham, United Kingdom
Investigative Site GB001
🇬🇧Dudley, United Kingdom
Investigative Site GB011
🇬🇧Ipswich, United Kingdom
Investigative Site GB002
🇬🇧Leeds, United Kingdom
Investigative Site GB009
🇬🇧Leicester, United Kingdom
Investigative Site GB013
🇬🇧Liverpool, United Kingdom
Investigative Site GB012
🇬🇧London, United Kingdom
Investigative Site GB005
🇬🇧London, United Kingdom
Investigative Site GB014
🇬🇧London, United Kingdom
Investigative Site GB010
🇬🇧Nottingham, United Kingdom
Investigative Site GB004
🇬🇧Salford, United Kingdom
Investigative Site GB008
🇬🇧Wolverhampton, United Kingdom