Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
2 other identifiers
interventional
136
3 countries
42
Brief Summary
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2023
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
July 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2025
CompletedResults Posted
Study results publicly available
March 12, 2026
CompletedMarch 12, 2026
March 1, 2026
1.6 years
June 26, 2023
February 18, 2026
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.
Baseline; Week 12
Secondary Outcomes (5)
Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12
Week 12
Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period
up to Week 12
Percentage of Participants With UAS7 = 0 at Week 12
Week 12
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
up to Week 12
Extension Period: Number of Participants With Any TEAE
from Week 12 to Week 44
Study Arms (4)
Povorcitinib Dose A
EXPERIMENTALParticipants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
Povorcitinib Dose B
EXPERIMENTALParticipants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
Povorcitinib Dose C
EXPERIMENTALParticipants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Placebo followed by Povorcitinib Dose A, B, or C
EXPERIMENTALParticipants 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.
Interventions
oral; tablet
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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.
You may not qualify if:
- Treatment with an anti-IgE biologic (eg, omalizumab) within 8 weeks prior to screening.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Cahaba Dermatology
Birmingham, Alabama, 35244, United States
Foothills Research Center
Scottsdale, Arizona, 85260, United States
Little Rock Allergy Asthma, Pa Clinical Research Center Lraac
Little Rock, Arkansas, 72205, United States
Arkansas Research Trials
North Little Rock, Arkansas, 72117, United States
First Oc Dermatology
Fountain Valley, California, 92708, United States
Newport Native Md
Newport Beach, California, 92663, United States
Antelope Valley Clinical Trials Lancaster Office
Palmdale, California, 93551, United States
Allergy and Asthma Consultants, Pc
Redwood City, California, 94063, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Midwest Allergy Sinus Asthma, Sc
Normal, Illinois, 61761, United States
Delricht Research
New Orleans, Louisiana, 70115, United States
David Fivenson, Md, Dermatology, Pllc
Ann Arbor, Michigan, 48103, United States
Revival Research Institute, Llc Troy
Troy, Michigan, 48084, United States
The Clinical Research Center Crc, Llc
St Louis, Missouri, 63141, United States
Optimed Research Ltd
Columbus, Ohio, 43235, United States
Central Sooner Research
Oklahoma City, Oklahoma, 73170, United States
Vital Prospects Clinical Research Institute, Pc Vpcri
Tulsa, Oklahoma, 74136, United States
Dermdox Center For Dermatology
Sugarloaf, Pennsylvania, 18249, United States
Allergy and Asthma Center of Charleston
Charleston, South Carolina, 29407, United States
Rainey and Finklea Dermatology
San Antonio, Texas, 78212, United States
Bellingham Asthma, Allergy Immunology Clinic
Bellingham, Washington, 98225, United States
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200, Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, 01307, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Mensingderma Research Gmbh
Hamburg, 22391, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105, Germany
Universitatsklinikum Leipzig Aor
Leipzig, 04103, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131, Germany
Klifos - Klinische Forschung Osnabruck
Osnabrück, 49074, Germany
Universitats-Hautklink Tubingen
Tübingen, 72076, Germany
Specderm Poznanska
Bialystok, 15-375, Poland
Centrum Medyczne Pratia Katowice I
Katowice, 40-081, Poland
Centrum Alergologii Sp Z.O.O
Lublin, 20-552, Poland
University Clinical Hospital
Opole, 45-401, Poland
Solumed Centrum Medyczne
Poznan, 60-529, Poland
Specjalistyczny Nzoz Alergologia Plus
Poznan, 60-693, Poland
DC-MED
Swidnica, 58-100, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
Warsaw, 02-507, Poland
Etg Warszawa
Warsaw, 02-793, Poland
Klinika Ambroziak
Warsaw, 02-953, Poland
Melita Medical Sp. Z O. O.
Wroclaw, 50-449, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 7, 2023
Study Start
July 31, 2023
Primary Completion
February 28, 2025
Study Completion
October 9, 2025
Last Updated
March 12, 2026
Results First Posted
March 12, 2026
Record last verified: 2026-03