Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

Chronic Spontaneous Urticaria Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936567
• Other study ID #: INCB54707-207
• Status: Recruiting
• Phase: Phase 2
• Start date: July 31, 2023
• Est. completion date: September 5, 2025

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: September 5, 2025
• Est. primary completion date: March 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angioedema
• Chronic Idiopathic Urticaria
• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Hives
• Pruritis
• Urticaria

Intervention

Drug:
• Povorcitinib
oral; tablet
• Placebo
oral; tablet

Locations

Country	Name	City	State
Germany	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
Poland	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	Etg Warszawa	Warszawa
Poland	Klinika Ambroziak	Warszawa
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji	Warszawa
Poland	Melita Medical Sp. Z O. O.	Wroclaw
United States	David Fivenson, Md, Dermatology, Pllc	Ann Arbor	Michigan
United States	Bellingham Asthma, Allergy Immunology Clinic	Bellingham	Washington
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Allergy and Asthma Center of Charleston	Charleston	South Carolina
United States	Optimed Research Ltd	Columbus	Ohio
United States	First Oc Dermatology	Fountain Valley	California
United States	Little Rock Allergy Asthma, Pa Clinical Research Center Lraac	Little Rock	Arkansas
United States	Newport Native Md	Newport Beach	California
United States	Midwest Allergy Sinus Asthma, Sc	Normal	Illinois
United States	Arkansas Research Trials	North Little Rock	Arkansas
United States	Antelope Valley Allergy Medical Group	Palmdale	California
United States	Allergy and Asthma Consultants, Pc	Redwood City	California
United States	The Clinical Research Center Crc, Llc	Saint Louis	Missouri
United States	Rainey and Finklea Dermatology	San Antonio	Texas
United States	Foothills Research Center	Scottsdale	Arizona
United States	Dermdox Center For Dermatology	Sugarloaf	Pennsylvania
United States	Revival Research Institute, Llc Troy	Troy	Michigan
United States	Vital Prospects Clinical Research Institute, Pc Vpcri	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the urticaria activity score (UAS7)	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.	12 Weeks
Secondary	Proportion of participants who achieve UAS7 = 6 (controlled disease) at Week 12	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.	12 Weeks
Secondary	Time to first achievement of UAS7 = 6 (controlled disease) during the PC period	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.	12 Weeks
Secondary	Proportion of participants with UAS7 = 0 at Week 12.	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.	12 Weeks