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UrticariaPhase 2NCT05936567

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

A Phase 2 study testing Povorcitinib in people with Urticaria and Chronic Spontaneous Urticaria, run by Incyte Corporation at 42 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Povorcitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
42 sitesin 3 countries
Study dates
31 Jul 2023to 9 Oct 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

42 sites in 3 countries.

42 sites in 3 countries

United States22 sites

  • David Fivenson, Md, Dermatology, Pllc

    Ann Arbor, Michigan, 48103

  • Bellingham Asthma, Allergy Immunology Clinic

    Bellingham, Washington, 98225

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209

  • Cahaba Dermatology

    Birmingham, Alabama, 35244

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Allergy and Asthma Center of Charleston

    Charleston, South Carolina, 29407

  • Optimed Research Ltd

    Columbus, Ohio, 43235

  • First Oc Dermatology

    Fountain Valley, California, 92708

  • Little Rock Allergy Asthma, Pa Clinical Research Center Lraac

    Little Rock, Arkansas, 72205

  • Delricht Research

    New Orleans, Louisiana, 70115

  • Newport Native Md

    Newport Beach, California, 92663

  • Midwest Allergy Sinus Asthma, Sc

    Normal, Illinois, 61761

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73170

  • Antelope Valley Clinical Trials Lancaster Office

    Palmdale, California, 93551

  • Allergy and Asthma Consultants, Pc

    Redwood City, California, 94063

  • Rainey and Finklea Dermatology

    San Antonio, Texas, 78212

  • Foothills Research Center

    Scottsdale, Arizona, 85260

  • The Clinical Research Center Crc, Llc

    St Louis, Missouri, 63141

  • Dermdox Center For Dermatology

    Sugarloaf, Pennsylvania, 18249

  • Revival Research Institute, Llc Troy

    Troy, Michigan, 48084

  • Vital Prospects Clinical Research Institute, Pc Vpcri

    Tulsa, Oklahoma, 74136

Other trials in United States

Poland11 sites

  • Specderm Poznanska

    Bialystok, 15-375

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-081

  • Centrum Alergologii Sp Z.O.O

    Lublin, 20-552

  • University Clinical Hospital

    Opole, 45-401

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • Specjalistyczny Nzoz Alergologia Plus

    Poznan, 60-693

  • DC-MED

    Swidnica, 58-100

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

    Warsaw, 02-507

  • Etg Warszawa

    Warsaw, 02-793

  • Klinika Ambroziak

    Warsaw, 02-953

  • Melita Medical Sp. Z O. O.

    Wroclaw, 50-449

Other trials in Poland

Germany9 sites

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Mensingderma Research Gmbh

    Hamburg, 22391

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105

  • Universitatsklinikum Leipzig Aor

    Leipzig, 04103

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

  • Klifos - Klinische Forschung Osnabruck

    Osnabrück, 49074

  • Universitats-Hautklink Tubingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: 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.

Being tested
Povorcitinib, Placebo
Medical subject headings
Urticaria, Chronic Urticaria, Angioedema, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PovorcitinibDrug

    oral; tablet

  • PlaceboDrug

    oral; tablet

Study groups in NCT05936567
Study groupRoleWhat they receive
Povorcitinib Dose AExperimentalParticipants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
Receives: Drug: Povorcitinib
Povorcitinib Dose BExperimentalParticipants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
Receives: Drug: Povorcitinib
Povorcitinib Dose CExperimentalParticipants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Receives: Drug: Povorcitinib
Placebo followed by Povorcitinib Dose A, B, or CExperimentalParticipants 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.
Receives: Drug: Povorcitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at 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.

    Measured: Baseline; Week 12

Secondary outcomes (5)

  1. Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at 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.

    Measured: Week 12

  2. Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period

    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.

    Measured: up to Week 12

  3. Percentage of Participants With UAS7 = 0 at 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.

    Measured: Week 12

  4. Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    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.

    Measured: up to Week 12

  5. Extension Period: Number of Participants With Any TEAE

    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.

    Measured: from Week 12 to Week 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start31 Jul 2023
  3. Primary completion28 Feb 2025
  4. Study completion9 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936567
Sponsor's protocol ID
INCB54707-207
Other IDs
2022-503062-72-00
Status last verified
Mar 2026
First submitted
26 Jun 2023
Last updated
12 Mar 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Povorcitinib in people with Urticaria and Chronic Spontaneous Urticaria, run by Incyte Corporation at 42 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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