Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
- Conditions
- UrticariaHivesAngioedemaPruritisChronic Spontaneous UrticariaChronic Idiopathic Urticaria
- Interventions
- Drug: Placebo
- Registration Number
- NCT05936567
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 136
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo followed by Povorcitinib Dose A, B, or C Povorcitinib Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period. Placebo followed by Povorcitinib Dose A, B, or C Placebo Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period. Povorcitinib Dose A Povorcitinib Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period. Povorcitinib Dose B Povorcitinib Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period. Povorcitinib Dose C Povorcitinib Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
- Primary Outcome Measures
Name Time Method Change from baseline in the urticaria activity score (UAS7) 12 Weeks 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.
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12 12 Weeks 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.
Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period 12 Weeks 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.
Proportion of participants with UAS7 = 0 at Week 12. 12 Weeks 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.
Trial Locations
- Locations (42)
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
🇺🇸Saint 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
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, Germany
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
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
🇵🇱Warszawa, Poland
Etg Warszawa
🇵🇱Warszawa, Poland
Klinika Ambroziak
🇵🇱Warszawa, Poland
Melita Medical Sp. Z O. O.
🇵🇱Wroclaw, Poland