Chronic Spontaneous Urticaria Clinical Trial
Official title:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | September 5, 2025 |
Est. primary completion date | March 7, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 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. - Further inclusion criteria apply Exclusion Criteria: - 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. - Further exclusion criteria apply. |
Country | Name | City | State |
---|---|---|---|
Germany | 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 | Tuebingen | |
Poland | 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 | Etg Warszawa | Warszawa | |
Poland | Klinika Ambroziak | Warszawa | |
Poland | Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji | Warszawa | |
Poland | Melita Medical Sp. Z O. O. | Wroclaw | |
United States | David Fivenson, Md, Dermatology, Pllc | Ann Arbor | Michigan |
United States | Bellingham Asthma, Allergy Immunology Clinic | Bellingham | Washington |
United States | Clinical Research Center of Alabama | Birmingham | Alabama |
United States | Treasure Valley Medical Research | Boise | Idaho |
United States | Allergy and Asthma Center of Charleston | Charleston | South Carolina |
United States | Optimed Research Ltd | Columbus | Ohio |
United States | First Oc Dermatology | Fountain Valley | California |
United States | Little Rock Allergy Asthma, Pa Clinical Research Center Lraac | Little Rock | Arkansas |
United States | Newport Native Md | Newport Beach | California |
United States | Midwest Allergy Sinus Asthma, Sc | Normal | Illinois |
United States | Arkansas Research Trials | North Little Rock | Arkansas |
United States | Antelope Valley Allergy Medical Group | Palmdale | California |
United States | Allergy and Asthma Consultants, Pc | Redwood City | California |
United States | The Clinical Research Center Crc, Llc | Saint Louis | Missouri |
United States | Rainey and Finklea Dermatology | San Antonio | Texas |
United States | Foothills Research Center | Scottsdale | Arizona |
United States | Dermdox Center For Dermatology | Sugarloaf | Pennsylvania |
United States | Revival Research Institute, Llc Troy | Troy | Michigan |
United States | Vital Prospects Clinical Research Institute, Pc Vpcri | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Germany, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the urticaria activity score (UAS7) | Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity. | 12 Weeks | |
Secondary | Proportion of participants who achieve UAS7 = 6 (controlled disease) at Week 12 | Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity. | 12 Weeks | |
Secondary | Time to first achievement of UAS7 = 6 (controlled disease) during the PC period | Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS. UAS scores range from 0-42; with higher scores reflecting greater disease activity. | 12 Weeks | |
Secondary | Proportion of participants with UAS7 = 0 at Week 12. | Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity. | 12 Weeks |
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