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Chronic Spontaneous UrticariaPhase 2NCT07219615

A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.

A Phase 2 study testing Ritlecitinib 50 mg and Ritlecitinib 100 mg in people with Chronic Spontaneous Urticaria, run by Pfizer at 77 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are used to stop the body's "allergy alarm system" from overreacting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
Ritlecitinib 50 mg and Ritlecitinib 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
77 sitesin 10 countries
Study dates
30 Oct 2025to 23 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age:
  • 18 years of age or older (or the minimum legal adult age as defined per local regulations, whichever is greater) at screening.
  • Disease Characteristics:
  • Participants must meet the following Chronic Spontaneous Urticaria (CSU) criteria:
  • 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.
  • 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.
  • 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.
  • 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

Who cannot join

  • Medical Conditions:
  • 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.).
  • 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.
Show all 31Show fewer
  • 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.
  • 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).
  • 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.
  • 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:
  • Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol defined timelines.
  • Prior/Concurrent Clinical Study Experience:
  • 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:
  • Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
  • Screening standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Other Exclusion Criteria:
  • 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.

Trial locations and contacts

77 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

77 sites in 10 countries

United States19 sites, 19 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Orion Clinical Research

    Austin, Texas, 78759

    Recruiting

  • Kern Research, Inc.

    Bakersfield, California, 93301

    Recruiting

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907

    Recruiting

  • Columbia Dermatology & Aesthetics

    Columbia, South Carolina, 29212

    Recruiting

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

    Recruiting

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

    Recruiting

  • Acuro Research, Inc.

    Little Rock, Arkansas, 72205

    Recruiting

  • Ark Clinical Research

    Long Beach, California, 90815

    Recruiting

  • Allergy, Asthma, & Clinical Research Center

    Oklahoma City, Oklahoma, 73120

    Recruiting

  • Skin & Beauty Center - Pasadena

    Pasadena, California, 91105

    Recruiting

  • Saguaro Dermatology - Phoenix

    Phoenix, Arizona, 85008

    Recruiting

  • Asthma and Allergy Center of Chicago

    River Forest, Illinois, 60305

    Recruiting

  • RFSA Dermatology - San Antonio - West Avenue

    San Antonio, Texas, 78213

    Recruiting

  • Complete Dermatology

    Sugar Land, Texas, 77479

    Recruiting

  • Equity Medical, LLC

    The Bronx, New York, 10455

    Recruiting

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

    Recruiting

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

    Recruiting

  • Chesapeake Clinical Research

    White Marsh, Maryland, 21162

    Recruiting

Other trials in United States

Canada8 sites, 8 recruiting

  • Laser Rejuvenation Clinics Edmonton D.T. Inc

    Edmonton, Alberta, T5J 3S9

    Recruiting

  • Allergy Centre Research

    Mississauga, Ontario, L4W 5G6

    Recruiting

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Recruiting

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario, L2H 1H5

    Recruiting

  • DAR Clinical Research

    Ottawa, Ontario, K1V 1C1

    Recruiting

  • Dar Clinical Research

    Ottawa, Ontario, K2T 0N7

    Recruiting

  • Centre de Recherche Saint-Louis inc.

    Québec, G1W 4R4

    Recruiting

  • CaRe Clinic

    Red Deer, Alberta, T4P 1K4

    Recruiting

Other trials in Canada

Poland8 sites, 8 recruiting

  • M2M Med Badania Sp. z o.o.

    Chorzów, 41-500

    Recruiting

  • Penta Hospitals Badania Kliniczne sp. z o.o.

    Gdansk, 80-546

    Recruiting

  • LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska

    Lublin, 20-573

    Recruiting

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

    Tarnów, 33-100

    Recruiting

  • ETG Warszawa

    Warsaw, Masovian Voivodeship, 02-677

    Recruiting

  • Klinika Osipowicz & Turkowski Sp. z o.o.

    Warsaw, 00-716

    Recruiting

  • Trialmed CRS - Warszawa

    Warsaw, 02-482

    Recruiting

  • Melita Medical

    Wroclaw, 53-611

    Recruiting

Other trials in Poland

Germany7 sites, 7 recruiting

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12203

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

    Dresden, 01307

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • Universitätsklinikum Marburg

    Marburg, 35043

    Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Recruiting

  • Hautarztpraxis Dres. Leitz & Kollegen

    Stuttgart, Baden-Wurttemberg, 70178

    Recruiting

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

    Recruiting

Other trials in Germany

Spain7 sites, 7 recruiting

  • Hospital Universitario Fundacion ALcorcon

    Alcorcón, Madrid, 28922

    Recruiting

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Barcelona [barcelona], 08003

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

    Recruiting

  • Clínica Gaias - Santiago

    Santiago de Compostela, A Coruña [LA Coruña], 15702

    Recruiting

  • Hospital Arnau de Vilanova

    Valencia, València, 46015

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Bulgaria6 sites, 6 recruiting

  • Medical Center Pulmo - 2018 EOOD

    Haskovo, 6300

    Recruiting

  • Diagnostic Consultative Center 1 - Pernik

    Pernik, 2300

    Recruiting

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia (stolitsa), 1431

    Recruiting

  • Diagnostic Consultative Center "Ascendent"

    Sofia, 1202

    Recruiting

  • Medical Center Hera EOOD

    Sofia, 1510

    Recruiting

  • Medical Center Pulmovision

    Sofia, 1756

    Recruiting

Other trials in Bulgaria

China6 sites, 6 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Recruiting

  • The Third Affiliated Hospital Of Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

    Recruiting

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310000

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Recruiting

Other trials in China

Japan6 sites, 6 recruiting

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

    Recruiting

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

    Recruiting

  • Tachikawa Dermatology Clinic

    Tachikawa, Tokyo, 190-0023

    Recruiting

  • Hattori Dermatology Clinic

    Takasaki, Gunma, 370-0071

    Recruiting

  • Queen's square Medical Facilities Queen's square Dermatology and Allergology

    Yokohama, Kanagawa, 220-6208

    Recruiting

  • Nomura Dermatology Clinic

    Yokohama, Kanagawa, 221-0825

    Recruiting

Other trials in Japan

South Korea5 sites, 5 recruiting

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do, 15355

    Recruiting

  • Pusan National University Hospital

    Busan, Pusan-kwangyǒkshi, 49241

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

    Recruiting

  • Chung-Ang University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 06973

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561 (R.O.C)

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • Mackay Memorial Hospital

    Taipei, 10449

    Recruiting

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, 333423

    Recruiting

Other trials in Taiwan

About this study

Official title: A PHASE 2B RANDOMIZED, DOUBLE-BLIND, 12-WEEK PLACEBO-CONTROLLED STUDY WITH A 12-WEEK DOUBLE-BLIND EXTENSION PERIOD TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH CHRONIC SPONTANEOUS URTICARIA

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are used to stop the body's "allergy alarm system" from overreacting. Chronic spontaneous urticaria is a disease that causes itchy hives and swellings in the deep layers of skin and fatty tissue just underneath the skin that come and go without a clear reason.

This study will look at both the 50 milligrams (mg) once daily (QD) oral dose and 100 milligrams (mg) once daily (QD) oral dose and compare them to placebo (pill with no active medicine).

Read more

This study is seeking participants who:

  • Are 18 years of age or older
  • Have a diagnosis of chronic spontaneous urticaria for 3 months or more that has not been controlled well with antihistamine treatment.
  • Do not have any other skin conditions associated with chronic itching or itching caused mainly by known triggers.
  • Are willing to stop all other treatments that they may be taking for chronic spontaneous urticaria other than a second-generation antihistamine (sgAH).

About 150 participants will take part in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive either the 50 mg dose or 100 mg dose or placebo, taken by mouth once daily for 12 weeks( Period A). Thereafter the participants on 50 mg and 100 mg will continue on their doses while the participants receiving placebo will be switched to 100mg for an additional 12 weeks (Period B). The 2 doses of ritlecitinib in this study will be compared to each other and to the placebo. This will help to see if the 50 mg and/or 100 mg dose of ritlecitinib is safe and effective.

Participants will be in this study for about 8 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:

  • Physical examinations,
  • Hearing tests,
  • Blood tests,
  • X-ray,
  • ECG (electrocardiogram),
  • Participants will also be asked to complete questionnaires every day about their chronic spontaneous urticaria in an electronic diary.
Being tested
Ritlecitinib 50 mg, Ritlecitinib 100 mg, Placebo - 50 mg, Placebo - 100 mg
Keywords
Hives, CSU, Urticaria, Chronic Hives, Itch
Medical subject headings
Chronic Urticaria, Urticaria, Pruritus

What participants receive

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

  • Ritlecitinib 50 mgDrug

    Also called PF-06651600, Litfulo

    50 mg Capsule

  • Ritlecitinib 100 mgDrug

    Also called PF-06651600, Litfulo

    100 mg Capsule

  • Placebo - 50 mgDrug

    Matching Capsule

  • Placebo - 100 mgDrug

    Matching Capsule

Study groups in NCT07219615
Study groupRoleWhat they receive
Arm 1ExperimentalRandomized to Ritlecitinib 50 mg for 24 weeks Periods A and B). In addition to the active Ritlecitinib 50 mg capsule, a placebo matching the Ritlecitinib 100 mg capsule will be given to maintain blind
Receives: Drug: Ritlecitinib 50 mg; Drug: Placebo - 100 mg
Arm 2ExperimentalRandomized to Ritlecitinib 100 mg for 24 weeks (Periods A and B). In addition to the active Ritlecitinib 100 mg capsule, a placebo matching the Ritlecitinib 50 mg capsule will be given to maintain blind
Receives: Drug: Ritlecitinib 100 mg; Drug: Placebo - 50 mg
Arm 3Placebo comparatorRandomized to placebos matching the Ritlecitinib 50 mg and Ritlecitinib 100 mg capsules will be given to maintain blind from Day 1 to Week 12 (Period A). From Week 12 to Week 24 (Period B), will be switched to Ritlecitinib 100 mg. In addition to the active Ritlecitinib 100 mg capsule, a placebo matching the Ritlecitinib 50 mg capsule will be given to maintain blind.
Receives: Drug: Ritlecitinib 100 mg; Drug: Placebo - 50 mg; Drug: Placebo - 100 mg

What is being measured

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

  1. Change from baseline in Urticaria Activity Score 7 (UAS7) at Week 12

    Measured: Week 12

  2. Incidence of Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events leading to discontinuation

    Measured: Week 12

Secondary outcomes (10)

  1. Change from baseline in UAS7 at all timepoints except Week 12

    Measured: Week 1 through Week 11

  2. Change from baseline in Itch Severity Score 7 (ISS7) at Week 12

    Measured: Week 12

  3. Change from baseline in Hives Severity Score 7 (HSS7) at Week 12

    Measured: Week 12

  4. Achieving complete response defined as UAS7=0 at Week 12

    Measured: Week 12

  5. Achieving UAS7 ≤6 at Week 12

    Measured: Week 12

  6. Achieving complete response defined as ISS7=0 at Week 12

    Measured: Week 12

  7. Achieving complete response defined as HSS7=0 at Week 12

    Measured: Week 12

  8. Time to achieving UAS7 ≤6

    Measured: Week 12

  9. Time to achieving improvement from baseline ≥10 in UAS7

    Measured: Week 12

  10. Incidence of TEAEs, SAEs, and AEs leading to discontinuation

    Measured: After Week 12 through Week 24

Timeline

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

  1. First posted22 Oct 2025
  2. Study start30 Oct 2025
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion23 Apr 2027 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07219615
Sponsor's protocol ID
B7981118
Other IDs
2025-522642-44-00, 2025
Status last verified
Oct 2026
First submitted
20 Oct 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ritlecitinib 50 mg and Ritlecitinib 100 mg in people with Chronic Spontaneous Urticaria, run by Pfizer at 77 sites in 10 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 8 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Canada, Poland, Germany, Spain and 5 more countries. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Urticaria Activity Score 7 (UAS7) at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT07219615.

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 26 Oct 2026.

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