Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
About the study
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Urticaria,Chronic Spontaneous Urticaria,Chronic Idiopathic Urticaria,Hives,Angioedema,Pruritis
Age
18+
Phase
PHASE2
Participants Needed
136
Est. Completion Date
Sep 5, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Incyte Corporation
ClinicalTrials.gov NCT Identifier
NCT05936567
Study Number
INCB 54707-207
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