Actively Recruiting
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Led by Pfizer · Updated on 2026-04-13
200
Participants Needed
52
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at screening.
- Have a diagnosis of chronic spontaneous urticaria for 3 months or more.
- Have chronic spontaneous urticaria not controlled well by second-generation antihistamines.
- Have had itching and hives for at least 6 consecutive weeks before screening while taking second-generation antihistamines.
- Have been on second-generation antihistamines at approved or higher doses for at least 7 consecutive days before symptom assessment.
- Have Urticaria Activity Score 7 (UAS7) of 16 or more and Itch Severity Score 7 (ISS7) of 8 or more during the 7 days before randomization.
- Complete at least 5 Urticaria Activity Score electronic diary entries in the 7 days before randomization.
- Be either anti-Immunoglobulin E (IgE) therapy naive or have stopped anti-IgE therapy at least 16 weeks before randomization if previously treated.
You will not qualify if you...
- Urticaria caused only by inducible urticaria.
- Other active skin diseases causing chronic itching or urticaria symptoms.
- History of severe allergic or anaphylactic reaction to kinase inhibitors or study drug components.
- Recent systemic infections requiring hospitalization or significant treatment within 3 months before dosing.
- Active infections requiring treatment within 4 weeks before dosing.
- Untreated or inadequately treated active or latent tuberculosis.
- History of disseminated or recurrent herpes infections.
- Positive for hepatitis B or C virus or HIV infection.
- Known immunodeficiency disorder or family history of hereditary immunodeficiency.
- Severe or uncontrolled medical conditions affecting various organs or systems.
- Progressive hearing loss or acute ear diseases.
- Abnormal chest imaging findings including active infections or malignancy.
- History of malignancies except treated nonmetastatic skin or cervical cancers.
- History of lymphoproliferative disorders.
- Recent major surgery or trauma within 1 month before dosing.
- Psychiatric conditions including recent suicidal ideation or behavior.
- Use of prohibited medications or treatments within protocol-defined timelines.
- Recent participation in other investigational drug or vaccine studies within 8 weeks before dosing.
- Abnormal laboratory or ECG findings affecting safety or study results.
- Investigator site staff and their families involved in the study conduct.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Acuro Research, Inc.
Little Rock, Arkansas, United States, 72205
Not Yet Recruiting
2
Kern Research. Inc.
Bakersfield, California, United States, 93301
Actively Recruiting
3
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
Actively Recruiting
4
Skin & Beauty Center - Pasadena
Pasadena, California, United States, 91105
Actively Recruiting
5
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 80907
Not Yet Recruiting
6
Asthma and Allergy Center of Chicago
River Forest, Illinois, United States, 60305
Actively Recruiting
7
Chesapeake Clinical Research
White Marsh, Maryland, United States, 21162
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
9
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
Actively Recruiting
10
Allergy, Asthma, & Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
11
Complete Dermatology
Sugar Land, Texas, United States, 77479
Actively Recruiting
12
Diagnostic Consultative Center 1 - Pernik
Pernik, Bulgaria, 2300
Not Yet Recruiting
13
Medical Center Hera EOOD
Sofia, Bulgaria, 1510
Actively Recruiting
14
Medical Center Pulmovision
Sofia, Bulgaria, 1756
Not Yet Recruiting
15
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
16
CaRe Clinic
Red Deer, Alberta, Canada, T4P 1K4
Actively Recruiting
17
Allergy Centre Research
Mississauga, Ontario, Canada, L4W 5G6
Actively Recruiting
18
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada, L2H 1H5
Actively Recruiting
19
DAR Clinical Research
Ottawa, Ontario, Canada, K1V 1C1
Not Yet Recruiting
20
Dar Clinical Research
Ottawa, Ontario, Canada, K2T 0N7
Actively Recruiting
21
Centre de Recherche Saint-Louis inc.
Québec, Canada, G1W 4R4
Actively Recruiting
22
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
23
The Third Affiliated Hospital Of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510630
Not Yet Recruiting
24
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Actively Recruiting
25
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
26
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Not Yet Recruiting
27
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
28
Hautarztpraxis Dres. Leitz & Kollegen
Stuttgart, Baden-Wurttemberg, Germany, 70178
Not Yet Recruiting
29
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany, 12203
Actively Recruiting
30
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
31
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42283
Not Yet Recruiting
32
Hattori Dermatology Clinic
Takasaki, Gunma, Japan, 370-0071
Not Yet Recruiting
33
Yokohama Queen's Tower C 8F
Yokohama, Kanagawa, Japan, 220-6208
Not Yet Recruiting
34
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan, 221-0825
Not Yet Recruiting
35
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan, 593-8324
Not Yet Recruiting
36
Tachikawa Dermatology Clinic
Tachikawa, Tokyo, Japan, 190-0023
Not Yet Recruiting
37
University of Miyazaki Hospital
Miyazaki, Japan, 889-1692
Not Yet Recruiting
38
ETG Warszawa
Warsaw, Masovian Voivodeship, Poland, 02-677
Not Yet Recruiting
39
M2M Med Badania Sp. z o.o.
Chorzów, Poland, 41-500
Actively Recruiting
40
ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.
Tarnów, Poland, 33-100
Not Yet Recruiting
41
Klinika Osipowicz & Turkowski Sp. z o.o.
Warsaw, Poland, 00-716
Not Yet Recruiting
42
Trialmed CRS - Warszawa
Warsaw, Poland, 02-482
Actively Recruiting
43
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, South Korea, 15355
Actively Recruiting
44
Pusan National University Hospital
Busan, Pusan-kwangyǒkshi, South Korea, 49241
Actively Recruiting
45
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
Actively Recruiting
46
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05505
Actively Recruiting
47
Chung-Ang University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06973
Actively Recruiting
48
Clínica Gaias - Santiago
Santiago de Compostela, A Coruña [LA Coruña], Spain, 15702
Not Yet Recruiting
49
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 23561 (R.O.C)
Actively Recruiting
50
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
51
National Taiwan University Hospital
Taipei, Taiwan, 100225
Not Yet Recruiting
52
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here