Clinical trial NCT05936567: Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Urticaria
Chronic Spontaneous Urticaria
Chronic Idiopathic Urticaria
Hives
Angioedema
Pruritis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

* 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.

Primary outcomes:
measure: Change from baseline in the urticaria activity score (UAS7)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12
timeFrame: 12 Weeks
measure: Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period
timeFrame: 12 Weeks
measure: Proportion of participants with UAS7 = 0 at Week 12.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Scottsdale
country: United States
facility: Foothills Research Center
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy Asthma, Pa Clinical Research Center Lraac
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Newport Beach
country: United States
facility: Newport Native Md
state: California
city: Palmdale
country: United States
facility: Antelope Valley Clinical Trials Lancaster Office
state: California
city: Redwood City
country: United States
facility: Allergy and Asthma Consultants, Pc
state: California
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Normal
country: United States
facility: Midwest Allergy Sinus Asthma, Sc
state: Illinois
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Ann Arbor
country: United States
facility: David Fivenson, Md, Dermatology, Pllc
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, Llc Troy
state: Michigan
city: Saint Louis
country: United States
facility: The Clinical Research Center Crc, Llc
state: Missouri
city: Columbus
country: United States
facility: Optimed Research Ltd
state: Ohio
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, Pc Vpcri
state: Oklahoma
city: Sugarloaf
country: United States
facility: Dermdox Center For Dermatology
state: Pennsylvania
city: Charleston
country: United States
facility: Allergy and Asthma Center of Charleston
state: South Carolina
city: San Antonio
country: United States
facility: Rainey and Finklea Dermatology
state: Texas
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy Immunology Clinic
state: Washington
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Tu Dresden
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Mensingderma Research Gmbh
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig Aor
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Osnabrück
country: Germany
facility: Klifos - Klinische Forschung Osnabruck
city: Tuebingen
country: Germany
facility: Universitats-Hautklink Tubingen
city: Bialystok
country: Poland
facility: Specderm Poznanska
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice I
city: Lublin
country: Poland
facility: Centrum Alergologii Sp Z.O.O
city: Opole
country: Poland
facility: University Clinical Hospital
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Poznan
country: Poland
facility: Specjalistyczny Nzoz Alergologia Plus
city: Swidnica
country: Poland
facility: DC-MED
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
city: Warszawa
country: Poland
facility: Etg Warszawa
city: Warszawa
country: Poland
facility: Klinika Ambroziak
city: Wroclaw
country: Poland
facility: Melita Medical Sp. Z O. O.
Study officials:
References: