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

NCT07219615 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: B79811182025-522642-44-00
• Study Type: interventional
• Target: 200
• Locations: 10 countries
• Sites: 52

Brief 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. 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). 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.

Conditions

Chronic Spontaneous Urticaria

Keywords

Hives; CSU; Urticaria; Chronic Hives; Itch

Outcome Measures

Primary Outcomes (2)

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

  Week 12

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

  Week 12

Secondary Outcomes (10)

• Change from baseline in UAS7 at all timepoints except Week 12

  Week 1 through Week 11

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

  Week 12

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

  Week 12

• Achieving complete response defined as UAS7=0 at Week 12

  Week 12

• Achieving UAS7 ≤6 at Week 12

  Week 12

Study Arms (3)

Arm 1

EXPERIMENTAL

Randomized 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

Drug: Ritlecitinib 50 mg; Drug: Placebo - 100 mg

Arm 2

EXPERIMENTAL

Randomized 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

Drug: Ritlecitinib 100 mg; Drug: Placebo - 50 mg

Arm 3

PLACEBO COMPARATOR

Randomized 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.

Drug: Ritlecitinib 100 mg; Drug: Placebo - 50 mg; Drug: Placebo - 100 mg

Interventions

Ritlecitinib 50 mg DRUG

50 mg Capsule

Also known as: PF-06651600, Litfulo

Arm 1

Ritlecitinib 100 mg DRUG

100 mg Capsule

Also known as: PF-06651600, Litfulo

Arm 2; Arm 3

Placebo - 50 mg DRUG

Matching Capsule

Arm 2; Arm 3

Placebo - 100 mg DRUG

Matching Capsule

Arm 1; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:
• 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:
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

Acuro Research, Inc.

Little Rock, Arkansas, 72205, United States

NOT YET RECRUITING

Kern Research. Inc.

Bakersfield, California, 93301, United States

RECRUITING

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

RECRUITING

Skin & Beauty Center - Pasadena

Pasadena, California, 91105, United States

RECRUITING

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907, United States

NOT YET RECRUITING

Asthma and Allergy Center of Chicago

River Forest, Illinois, 60305, United States

RECRUITING

Chesapeake Clinical Research

White Marsh, Maryland, 21162, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

RECRUITING

Allergy, Asthma, & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Complete Dermatology

Sugar Land, Texas, 77479, United States

RECRUITING

Diagnostic Consultative Center 1 - Pernik

Pernik, 2300, Bulgaria

NOT YET RECRUITING

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

RECRUITING

Medical Center Pulmovision

Sofia, 1756, Bulgaria

NOT YET RECRUITING

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

CaRe Clinic

Red Deer, Alberta, T4P 1K4, Canada

RECRUITING

Allergy Centre Research

Mississauga, Ontario, L4W 5G6, Canada

RECRUITING

Allergy Research Canada Inc.

Niagara Falls, Ontario, L2H 1H5, Canada

RECRUITING

DAR Clinical Research

Ottawa, Ontario, K1V 1C1, Canada

NOT YET RECRUITING

Dar Clinical Research

Ottawa, Ontario, K2T 0N7, Canada

RECRUITING

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada

RECRUITING

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, 100050, China

NOT YET RECRUITING

The Third Affiliated Hospital Of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

NOT YET RECRUITING

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Hautarztpraxis Dres. Leitz & Kollegen

Stuttgart, Baden-Wurttemberg, 70178, Germany

NOT YET RECRUITING

Charite Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

NOT YET RECRUITING

Hattori Dermatology Clinic

Takasaki, Gunma, 370-0071, Japan

NOT YET RECRUITING

Yokohama Queen's Tower C 8F

Yokohama, Kanagawa, 220-6208, Japan

NOT YET RECRUITING

Nomura Dermatology Clinic

Yokohama, Kanagawa, 221-0825, Japan

NOT YET RECRUITING

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

NOT YET RECRUITING

Tachikawa Dermatology Clinic

Tachikawa, Tokyo, 190-0023, Japan

NOT YET RECRUITING

University of Miyazaki Hospital

Miyazaki, 889-1692, Japan

NOT YET RECRUITING

ETG Warszawa

Warsaw, Masovian Voivodeship, 02-677, Poland

NOT YET RECRUITING

M2M Med Badania Sp. z o.o.

Chorzów, 41-500, Poland

RECRUITING

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

Tarnów, 33-100, Poland

NOT YET RECRUITING

Klinika Osipowicz & Turkowski Sp. z o.o.

Warsaw, 00-716, Poland

NOT YET RECRUITING

Trialmed CRS - Warszawa

Warsaw, 02-482, Poland

RECRUITING

Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, 15355, South Korea

RECRUITING

Pusan National University Hospital

Busan, Pusan-kwangyǒkshi, 49241, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 06973, South Korea

RECRUITING

Clínica Gaias - Santiago

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

NOT YET RECRUITING

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

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

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

NOT YET RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

NOT YET RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Chronic Urticaria; Urticaria; Pruritus

Interventions

PF-06651600

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): April 23, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (11); JP (6); CN (6); KR (5); ES (1); TW (4); PL (5); BU (3); DE (4); CA (7)