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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT05936567
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Povorcitinib — DRUG
    oral; tablet
  • Placebo — DRUG
    oral; tablet

Study Details

This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

Key Dates

Start date
Jul 31, 2023
Status verified
Mar 2026
Primary completion
Feb 28, 2025
Completion
Oct 9, 2025

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Povorcitinib Dose A
    Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
  • Experimental: Povorcitinib Dose B
    Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
  • Experimental: Povorcitinib Dose C
    Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
  • Experimental: Placebo followed by Povorcitinib Dose A, B, or C
    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.

Primary Outcome Measure

Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 [ Time Frame: Baseline; Week 12 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Cahaba DermatologyBirminghamAlabama35244-
Clinical Research Center of AlabamaBirminghamAlabama35209-
Foothills Research CenterScottsdaleArizona85260-
Little Rock Allergy Asthma, Pa Clinical Research Center LraacLittle RockArkansas72205-
Arkansas Research TrialsNorth Little RockArkansas72117-
First Oc DermatologyFountain ValleyCalifornia92708-
Newport Native MdNewport BeachCalifornia92663-
Antelope Valley Clinical Trials Lancaster OfficePalmdaleCalifornia93551-
Allergy and Asthma Consultants, PcRedwood CityCalifornia94063-
Treasure Valley Medical ResearchBoiseIdaho83706-
Midwest Allergy Sinus Asthma, ScNormalIllinois61761-
Delricht ResearchNew OrleansLouisiana70115-
David Fivenson, Md, Dermatology, PllcAnn ArborMichigan48103-
Revival Research Institute, Llc TroyTroyMichigan48084-
The Clinical Research Center Crc, LlcSt LouisMissouri63141-
Optimed Research LtdColumbusOhio43235-
Central Sooner ResearchOklahoma CityOklahoma73170-
Vital Prospects Clinical Research Institute, Pc VpcriTulsaOklahoma74136-
Dermdox Center For DermatologySugarloafPennsylvania18249-
Allergy and Asthma Center of CharlestonCharlestonSouth Carolina29407-
Rainey and Finklea DermatologySan AntonioTexas78212-
Bellingham Asthma, Allergy Immunology ClinicBellinghamWashington98225-

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