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Study Evaluating the Efficacy and Safety of Povorcitinib in Adults 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.
Conditions:
Urticaria Chronic Spontaneous Urticaria Chronic Idiopathic Urticaria Hives Angioedema Pruritis
Study Start (Actual) 2023-07-31
Primary Completion (Estimated) 2025-03-07
Study Completion (Estimated) 2025-09-05
Enrollment (Estimated) 136
Study Type INTERVENTIONAL
Phase PHASE2
Locations:
📍 Birmingham, Alabama, United States
📍 Birmingham, Alabama, United States
📍 Scottsdale, Arizona, United States
📍 Little Rock, Arkansas, United States
📍 North Little Rock, Arkansas, United States
📍 Fountain Valley, California, United States
📍 Newport Beach, California, United States
📍 Palmdale, California, United States
📍 Redwood City, California, United States
📍 Boise, Idaho, United States
📍 Normal, Illinois, United States
📍 New Orleans, Louisiana, United States
📍 Ann Arbor, Michigan, United States
📍 Troy, Michigan, United States
📍 Saint Louis, Missouri, United States
📍 Columbus, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Tulsa, Oklahoma, United States
📍 Sugarloaf, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 San Antonio, Texas, United States
📍 Bellingham, Washington, United States
📍 Berlin, Germany
📍 Dresden, Germany
📍 Frankfurt, Germany
📍 Hamburg, Germany
📍 Kiel, Germany
📍 Leipzig, Germany
📍 Mainz, Germany
📍 Osnabrück, Germany
📍 Tuebingen, Germany
📍 Bialystok, Poland
📍 Katowice, Poland
📍 Lublin, Poland
📍 Opole, Poland
📍 Poznan, Poland
📍 Poznan, Poland
📍 Swidnica, Poland
📍 Warszawa, Poland
📍 Warszawa, Poland
📍 Warszawa, Poland
📍 Wroclaw, Poland
More locations available...

Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2023-06-26
  • First Submitted that Met QC Criteria2023-07-06
  • First Posted2023-07-07

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-07-24
  • Last Update Posted2024-07-26
  • Last Verified2024-07
I'm interested ...!!