Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

Completed · Phase 2 · Has a placebo group

Conditions studied: Urticaria, Chronic Spontaneous Urticaria, Chronic Idiopathic Urticaria, Hives, Angioedema, Pruritis

In brief

This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

Key facts

Study ID

NCT05936567

Run by

Incyte Corporation

People needed

136

Starts

2023-07-31

Expected to finish

2025-10-09

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• Further inclusion criteria apply

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.
• Further exclusion criteria apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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