New pill could soothe stubborn hives when allergy meds fail

NCT ID NCT07219615

Symptom relief Sponsor: Pfizer Source: ClinicalTrials.gov ↗

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

Summary

This study tests an experimental daily pill, ritlecitinib, for adults with chronic spontaneous urticaria (long-term itchy hives and swelling) that antihistamines don't fully control. About 200 participants will receive either 50 mg, 100 mg, or a placebo for 12 weeks, then all will get active treatment for another 12 weeks. The goal is to see if the drug safely reduces hives and itching.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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 years and older

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: Age: 1. 18 years of age or older (or the minimum legal adult age as defined per local regulations, whichever is greater) at screening. Disease Characteristics: 2. Participants must meet the following Chronic Spontaneous Urticaria (CSU) criteria: a. Chronic spontaneous urticaria diagnosis for ≥3 months at the time of screening (with the onset date assessed by the Investigator based on all available records) b. Diagnosis of CSU inadequately controlled by second generation antihistamine (sgAH) at the time of randomization, defined as: (i) The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgAH during this time period. (ii) Participants must have been on a sgAH at locally approved dose or higher for treatment of CSU for at least 7 consecutive days before screening assessment of UAS7 and ISS7 is initiated. (iii) Urticaria Activity Score 7 (UAS7) ≥16 (range 0-42) and an Itch Severity Score 7 (ISS7) ≥8 (range: 0-21) during the 7 days prior to randomization Day 1 c. Participants must complete at least 5 Urticaria Activity Score (UAS) eDiary entries during the 7 days immediately preceding randomization (Day 1) to confirm eligibility. If this requirement is not met due to documented, limited circumstances such as technical issues or short-term illness, the screening period may be extended only for the number of days necessary to allow completion of 5 UAS entries within any 7-day window. This extension period must not exceed 7 days. d. Anti-Immunoglobulin E-naïve (IgE-naïve) and Anti-Immunoglobulin E-experienced (Anti-IgE-experienced) participants. Anti-IgE-experienced participants are defined as meeting any of the following criteria confirmed by the Site Investigator: (i) Did not adequately respond to the approved dosage of an anti-IgE therapy (eg, omalizumab 300 mg Q4W or an alternate approved anti-IgE therapy) for at least 3 months, as assessed by the Investigator (ii) Could not tolerate an anti-IgE therapy (iii) Stopped an anti-IgE therapy for any reason, eg, loss of access e. Anti-IgE-experienced participants must have stopped anti-IgE therapy for at least 16 weeks, or 5 half-lives, whichever is longer, prior to randomization Day 1 Exclusion Criteria: Medical Conditions: 1. Medical conditions pertaining to CSU and other diseases/conditions affecting the skin * Urticaria is solely due to inducible urticaria. * Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms, including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to Complement 1 (C1) inhibitor deficiency). * Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigold, dermatitis herpetiformis, senile pruritus, etc.). 2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention. 3. General Infection History: * Having a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1. * Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. * Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis. 4. Specific Viral Infection History * History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster. * Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility. * Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency (unless known negative carrier status). 5. Other Medical Conditions * Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hyperthyroidism or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements. * Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive. * Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening. * Have any malignancies or have a 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. * Have a history of any lymphoproliferative disorder such as Epstein-Barr Virus (EBV)-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery. Participants with elective surgery scheduled to occur during the study can only be enrolled with approval of the sponsor. 6. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Any psychiatric condition including recent or active suicidal ideation or behavior that protocol-defined criteria. Prior/Concomitant Therapy: 7. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol defined timelines. Prior/Concurrent Clinical Study Experience: 8. Previous administration of an investigational product (drug or vaccine) within 8 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study. Diagnostic Assessments: 9. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat. 10. Screening standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. Other Exclusion Criteria: 11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria Pruritus urticaria

As listed by the trial registrant

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

Chronic spontaneous urticaria

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

69 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.
RECRUITING

Tarnów, 33-100, Poland
Acuro Research, Inc.
RECRUITING

Little Rock, Arkansas, 72205, United States
Allergy Centre Research
RECRUITING

Mississauga, Ontario, L4W 5G6, Canada
Allergy Research Canada Inc.
RECRUITING

Niagara Falls, Ontario, L2H 1H5, Canada
Allergy, Asthma, & Clinical Research Center
RECRUITING

Oklahoma City, Oklahoma, 73120, United States
Antelope Valley Clinical Trials
RECRUITING

Lancaster, California, 93534, United States
Asan Medical Center
RECRUITING

Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea
Asthma and Allergy Associates, PC
RECRUITING

Colorado Springs, Colorado, 80907, United States
Asthma and Allergy Center of Chicago
RECRUITING

River Forest, Illinois, 60305, United States
Beijing Friendship Hospital, Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100050, China
CaRe Clinic
RECRUITING

Red Deer, Alberta, T4P 1K4, Canada
Centre de Recherche Saint-Louis inc.
RECRUITING

Québec, G1W 4R4, Canada
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING

Gdansk, 80-546, Poland
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
RECRUITING

Taoyuan, 333423, Taiwan
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
RECRUITING

Berlin, 12203, Germany
Chesapeake Clinical Research
RECRUITING

White Marsh, Maryland, 21162, United States
China Medical University Hospital
RECRUITING

Taichung, 40447, Taiwan
Chung-Ang University Hospital
RECRUITING

Seoul, Seoul-teukbyeolsi [seoul], 06973, South Korea
Clínica Gaias - Santiago
RECRUITING

Santiago de Compostela, A Coruña [LA Coruña], 15702, Spain
Complete Dermatology
RECRUITING

Sugar Land, Texas, 77479, United States
DAR Clinical Research
RECRUITING

Ottawa, Ontario, K1V 1C1, Canada
Dar Clinical Research
RECRUITING

Ottawa, Ontario, K2T 0N7, Canada
Dermatology and Ophthalmology Kume Clinic
RECRUITING

Sakai, Osaka, 593-8324, Japan
Diagnostic Consultative Center "Ascendent"
RECRUITING

Sofia, 1202, Bulgaria
Diagnostic Consultative Center 1 - Pernik
RECRUITING

Pernik, 2300, Bulgaria
Diagnostic Consultative Center Aleksandrovska
RECRUITING

Sofia, Sofia (stolitsa), 1431, Bulgaria
ETG Warszawa
RECRUITING

Warsaw, Masovian Voivodeship, 02-677, Poland
First OC Dermatology Research Inc
RECRUITING

Fountain Valley, California, 92708, United States
Hattori Dermatology Clinic
RECRUITING

Takasaki, Gunma, 370-0071, Japan
Hautarztpraxis Dres. Leitz & Kollegen
RECRUITING

Stuttgart, Baden-Wurttemberg, 70178, Germany
Helios Universitätsklinikum Wuppertal
RECRUITING

Wuppertal, 42283, Germany
Hospital Arnau de Vilanova
RECRUITING

Valencia, València, 46015, Spain
Hospital Universitario Fundacion ALcorcon
RECRUITING

Alcorcón, Madrid, 28922, Spain
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING

Córdoba, Andalusia, 14004, Spain
Huashan Hospital, Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 200040, China
Kern Research. Inc.
RECRUITING

Bakersfield, California, 93301, United States
Klinika Osipowicz & Turkowski Sp. z o.o.
RECRUITING

Warsaw, 00-716, Poland
Korea University Ansan Hospital
RECRUITING

Ansan-si, Kyǒnggi-do, 15355, South Korea
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
RECRUITING

Lublin, 20-573, Poland
Laser Rejuvenation Clinics Edmonton D.T. Inc
RECRUITING

Edmonton, Alberta, T5J 3S9, Canada
M2M Med Badania Sp. z o.o.
RECRUITING

Chorzów, 41-500, Poland
Mackay Memorial Hospital
RECRUITING

Taipei, 10449, Taiwan
Medical Center Hera EOOD
RECRUITING

Sofia, 1510, Bulgaria
Medical Center Pulmo - 2018 EOOD
RECRUITING

Haskovo, 6300, Bulgaria
Medical Center Pulmovision
RECRUITING

Sofia, 1756, Bulgaria
Melita Medical
RECRUITING

Wroclaw, 53-611, Poland
National Taiwan University Hospital
RECRUITING

Taipei, 100225, Taiwan
Nomura Dermatology Clinic
RECRUITING

Yokohama, Kanagawa, 221-0825, Japan
Orion Clinical Research
RECRUITING

Austin, Texas, 78759, United States
Parc de Salut Mar - Hospital del Mar
RECRUITING

Barcelona, Barcelona [barcelona], 08003, Spain
Pusan National University Hospital
RECRUITING

Busan, Pusan-kwangyǒkshi, 49241, South Korea
RFSA Dermatology - San Antonio - West Avenue
RECRUITING

San Antonio, Texas, 78213, United States
Revival Research Institute, LLC
RECRUITING

Troy, Michigan, 48084, United States
Saguaro Dermatology - Phoenix
NOT_YET_RECRUITING

Phoenix, Arizona, 85008, United States
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Skin & Beauty Center - Pasadena
RECRUITING

Pasadena, California, 91105, United States
Tachikawa Dermatology Clinic
RECRUITING

Tachikawa, Tokyo, 190-0023, Japan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
RECRUITING

New Taipei City, 23561 (R.O.C), Taiwan
The First Hospital of Hebei Medical University
RECRUITING

Shijiazhuang, Hebei, 050031, China
The First People's Hospital of Hangzhou
RECRUITING

Hangzhou, Zhejiang, 310000, China
The Third Affiliated Hospital Of Sun Yat-Sen University
RECRUITING

Guangzhou, Guangdong, 510630, China
Tianjin Medical University General Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300052, China
Trialmed CRS - Warszawa
RECRUITING

Warsaw, 02-482, Poland
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
RECRUITING

Dresden, 01307, Germany
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Miyazaki Hospital
RECRUITING

Miyazaki, 889-1692, Japan
Universitätsklinikum Leipzig
RECRUITING

Leipzig, 04103, Germany
Universitätsklinikum Münster
RECRUITING

Münster, North Rhine-Westphalia, 48149, Germany
Yokohama Queen's Tower C 8F
RECRUITING

Yokohama, Kanagawa, 220-6208, Japan

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