Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
NCT ID: NCT05936567
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2023-07-31
2025-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Povorcitinib Dose A
Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
Povorcitinib
oral; tablet
Povorcitinib Dose B
Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
Povorcitinib
oral; tablet
Povorcitinib Dose C
Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Povorcitinib
oral; tablet
Placebo followed by Povorcitinib Dose A, B, or C
Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.
Povorcitinib
oral; tablet
Placebo
oral; tablet
Interventions
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Povorcitinib
oral; tablet
Placebo
oral; tablet
Eligibility Criteria
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Inclusion Criteria
* CSU diagnosis for ≥ 3 months prior to screening.
* CSU refractory to second-generation H1 antihistamines
* Participants must have been on a stable dose of second-generation H1 antihistamine, and must agree to maintain the stable dose of second-generation H1 antihistamine throughout study.
* Willingness and ability to comply with the study Protocol and procedures.
Exclusion Criteria
* Clearly defined underlying etiology for chronic urticarias other than CSU
* Other cutaneous or systemic diseases with chronic itching or with symptoms of urticaria or angioedema.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Concurrent or history of Thrombocytopenia, coagulopathy, or platelet dysfunction, Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, MI, coronary stenting, or CABG surgery, other significant cardiovascular diseases or uncontrolled hypertension
* Recipient of an organ transplant that requires continued immunosuppression.
* Any malignancies or history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
* Chronic or recurrent infectious disease.
18 Years
65 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Cahaba Dermatology
Birmingham, Alabama, United States
Foothills Research Center
Scottsdale, Arizona, United States
Little Rock Allergy Asthma, Pa Clinical Research Center Lraac
Little Rock, Arkansas, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
First Oc Dermatology
Fountain Valley, California, United States
Newport Native Md
Newport Beach, California, United States
Antelope Valley Clinical Trials Lancaster Office
Palmdale, California, United States
Allergy and Asthma Consultants, Pc
Redwood City, California, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Midwest Allergy Sinus Asthma, Sc
Normal, Illinois, United States
Delricht Research
New Orleans, Louisiana, United States
David Fivenson, Md, Dermatology, Pllc
Ann Arbor, Michigan, United States
Revival Research Institute, Llc Troy
Troy, Michigan, United States
The Clinical Research Center Crc, Llc
St Louis, Missouri, United States
Optimed Research Ltd
Columbus, Ohio, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, Pc Vpcri
Tulsa, Oklahoma, United States
Dermdox Center For Dermatology
Sugarloaf, Pennsylvania, United States
Allergy and Asthma Center of Charleston
Charleston, South Carolina, United States
Rainey and Finklea Dermatology
San Antonio, Texas, United States
Bellingham Asthma, Allergy Immunology Clinic
Bellingham, Washington, United States
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Mensingderma Research Gmbh
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Universitatsklinikum Leipzig Aor
Leipzig, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Klifos - Klinische Forschung Osnabruck
Osnabrück, , Germany
Universitats-Hautklink Tubingen
Tübingen, , Germany
Specderm Poznanska
Bialystok, , Poland
Centrum Medyczne Pratia Katowice I
Katowice, , Poland
Centrum Alergologii Sp Z.O.O
Lublin, , Poland
University Clinical Hospital
Opole, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Specjalistyczny Nzoz Alergologia Plus
Poznan, , Poland
DC-MED
Swidnica, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
Warsaw, , Poland
Etg Warszawa
Warsaw, , Poland
Klinika Ambroziak
Warsaw, , Poland
Melita Medical Sp. Z O. O.
Wroclaw, , Poland
Countries
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Related Links
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Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
Other Identifiers
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2022-503062-72-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB54707-207
Identifier Type: -
Identifier Source: org_study_id
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