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

March 11, 2026 updated by: Incyte Corporation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Hamburg, Germany, 22391
        • MensingDerma Research GmbH
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR
      • Mainz, Germany, 55131
        • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
      • Osnabrück, Germany, 49074
        • KliFOs - Klinische Forschung Osnabrück
      • Tübingen, Germany, 72076
        • Universitats-Hautklink Tubingen
  • Poland
      • Bialystok, Poland, 15-375
        • Specderm Poznanska
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice I
      • Lublin, Poland, 20-552
        • Centrum Alergologii Sp Z.O.O
      • Opole, Poland, 45-401
        • University Clinical Hospital
      • Poznan, Poland, 60-529
        • SOLUMED Centrum Medyczne
      • Poznan, Poland, 60-693
        • Specjalistyczny Nzoz Alergologia Plus
      • Swidnica, Poland, 58-100
        • DC-MED
      • Warsaw, Poland, 02-793
        • ETG Warszawa
      • Warsaw, Poland, 02-953
        • Klinika Ambroziak
      • Warsaw, Poland, 02-507
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
      • Wroclaw, Poland, 50-449
        • Melita Medical Sp. Z O. O.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Foothills Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Allergy Asthma, Pa Clinical Research Center Lraac
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Research Trials
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Newport Beach, California, United States, 92663
        • Newport Native Md
      • Palmdale, California, United States, 93551
        • Antelope Valley Clinical Trials Lancaster Office
      • Redwood City, California, United States, 94063
        • Allergy and Asthma Consultants, Pc
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Normal, Illinois, United States, 61761
        • Midwest Allergy Sinus Asthma, Sc
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, MD, Dermatology, PLLC
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, Llc Troy
    • Missouri
      • St Louis, Missouri, United States, 63141
        • The Clinical Research Center Crc, Llc
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Optimed Research LTD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73170
        • Central Sooner Research
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute, Pc Vpcri
    • Pennsylvania
      • Sugarloaf, Pennsylvania, United States, 18249
        • Dermdox Center For Dermatology
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Allergy and Asthma Center of Charleston
    • Texas
      • San Antonio, Texas, United States, 78212
        • Rainey and Finklea Dermatology
    • Washington
      • Bellingham, Washington, United States, 98225
        • Bellingham Asthma, Allergy Immunology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Povorcitinib
oral; tablet
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.
Drug: Povorcitinib
oral; tablet
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.
Drug: Povorcitinib
oral; tablet
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.
Drug: Povorcitinib
oral; tablet
Drug: Placebo
oral; tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
Time Frame: Baseline; Week 12
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.
Baseline; Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12
Time Frame: Week 12
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.
Week 12
Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period
Time Frame: up to Week 12
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.
up to Week 12
Percentage of Participants With UAS7 = 0 at Week 12
Time Frame: Week 12
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.
Week 12
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time Frame: up to Week 12
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 60 days after the last dose of study drug.
up to Week 12
Extension Period: Number of Participants With Any TEAE
Time Frame: from Week 12 to Week 44
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 60 days after the last dose of study drug.
from Week 12 to Week 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCB54707-207
  • 2022-503062-72-00 (Registry Identifier: EU CT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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