Hives
Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
Incyte Study ID:
INCB54707-207
CT.gov ID:
Eudra ID:
N/A
EU CT Number:
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jul 2023 - Sep 2025
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18 - 65 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
CHARITE UNIVERSITAETSMEDIZIN BERLIN - CAMPUS BENJAMIN FRANKLIN
BERLIN, Germany, 12200
Name
UNIVERSITATS-HAUTKLINK TUBINGEN
TUEBINGEN, Germany, 72076
Name
UNIVERSITAETSKLINIKUM CARL GUSTAV CARUS TU DRESDEN
DRESDEN, Germany, 01307
Name
UNIVERSITATSKLINIKUM FRANKFURT
FRANKFURT, Germany, 60590
Name
KLIFOS - KLINISCHE FORSCHUNG OSNABRUCK
OSNABRÜCK, Germany, 49074
Name
UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - CAMPUS KIEL
KIEL, Germany, 24105
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Key Inclusion and Exclusion 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.
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
Requirements information
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.
Protocol Summary
Incyte Study ID:
INCB54707-207
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Interventions:
Enrollment:
136
Primary Outcome
Open
Change from baseline in the urticaria activity score (UAS7)
Timeframe: 12 Weeks
Secondary Outcome
Open
Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12
Timeframe: 12 Weeks
Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period
Timeframe: 12 Weeks
Proportion of participants with UAS7 = 0 at Week 12.
Timeframe: 12 Weeks