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New pill could tame stubborn hives when antihistamines fail

NCT ID NCT05936567

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested an oral drug called povorcitinib in 136 adults with chronic spontaneous urticaria (hives and itching lasting months) that standard antihistamines couldn't control. Participants took either povorcitinib or a placebo for 12 weeks to see if the drug reduced hive and itch scores. The goal is to find a new option for people whose hives don't improve with usual care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
povorcitinib (oral tablet)
What this could lead to
If it works, this could provide a new treatment option for people with chronic hives that don't respond to standard antihistamines.
What could go wrong
This is an early phase 2 trial with only 136 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

136 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

angioedema chronic idiopathic urticaria Chronic Urticaria Pruritus urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Angioedema Chronic idiopathic urticaria Chronic spontaneous urticaria Hives Pruritis Urticaria

Contacts and locations

Locations

  • Allergy and Asthma Center of Charleston

    Charleston, South Carolina, 29407, United States

  • Allergy and Asthma Consultants, Pc

    Redwood City, California, 94063, United States

  • Antelope Valley Clinical Trials Lancaster Office

    Palmdale, California, 93551, United States

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117, United States

  • Bellingham Asthma, Allergy Immunology Clinic

    Bellingham, Washington, 98225, United States

  • Cahaba Dermatology

    Birmingham, Alabama, 35244, United States

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73170, United States

  • Centrum Alergologii Sp Z.O.O

    Lublin, 20-552, Poland

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-081, Poland

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200, Germany

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209, United States

  • DC-MED

    Swidnica, 58-100, Poland

  • David Fivenson, Md, Dermatology, Pllc

    Ann Arbor, Michigan, 48103, United States

  • Delricht Research

    New Orleans, Louisiana, 70115, United States

  • Dermdox Center For Dermatology

    Sugarloaf, Pennsylvania, 18249, United States

  • Etg Warszawa

    Warsaw, 02-793, Poland

  • First Oc Dermatology

    Fountain Valley, California, 92708, United States

  • Foothills Research Center

    Scottsdale, Arizona, 85260, United States

  • Klifos - Klinische Forschung Osnabruck

    Osnabrück, 49074, Germany

  • Klinika Ambroziak

    Warsaw, 02-953, Poland

  • Little Rock Allergy Asthma, Pa Clinical Research Center Lraac

    Little Rock, Arkansas, 72205, United States

  • Melita Medical Sp. Z O. O.

    Wroclaw, 50-449, Poland

  • Mensingderma Research Gmbh

    Hamburg, 22391, Germany

  • Midwest Allergy Sinus Asthma, Sc

    Normal, Illinois, 61761, United States

  • Newport Native Md

    Newport Beach, California, 92663, United States

  • Optimed Research Ltd

    Columbus, Ohio, 43235, United States

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

    Warsaw, 02-507, Poland

  • Rainey and Finklea Dermatology

    San Antonio, Texas, 78212, United States

  • Revival Research Institute, Llc Troy

    Troy, Michigan, 48084, United States

  • Solumed Centrum Medyczne

    Poznan, 60-529, Poland

  • Specderm Poznanska

    Bialystok, 15-375, Poland

  • Specjalistyczny Nzoz Alergologia Plus

    Poznan, 60-693, Poland

  • The Clinical Research Center Crc, Llc

    St Louis, Missouri, 63141, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105, Germany

  • Universitats-Hautklink Tubingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitatsklinikum Leipzig Aor

    Leipzig, 04103, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • University Clinical Hospital

    Opole, 45-401, Poland

  • Vital Prospects Clinical Research Institute, Pc Vpcri

    Tulsa, Oklahoma, 74136, United States

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