Actively Recruiting
A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effects of Ritlecitinib in Adults With Chronic Spontaneous Urticaria
Led by Pfizer · Updated on 2026-04-13
200
Participants Needed
52
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a medicine called ritlecitinib for adults with chronic spontaneous urticaria (CSU), a condition that causes itchy hives and deep skin swellings without a clear cause. The study focuses on people whose CSU is not well controlled by antihistamines, aiming to see if ritlecitinib doses can help manage their symptoms. This Phase 2 study is sponsored by Pfizer and compares two doses of ritlecitinib to placebo to better understand the treatment's safety and impact. Participants will be randomly assigned to receive either 50 mg or 100 mg of ritlecitinib or a placebo pill once daily. For the first 12 weeks (Period A), some receive placebo, then from weeks 12 to 24 (Period B), those on placebo switch to 100 mg ritlecitinib while others continue their doses. This design allows comparison of the two doses and placebo over 24 weeks, with capsules matched to maintain blinding. During about 8 months of participation, individuals will visit the study site up to nine times for physical exams, hearing tests, blood tests, chest X-rays, and ECGs. Participants will also complete daily electronic diaries about their urticaria symptoms. Researchers will measure changes in symptom scores like the Urticaria Activity Score 7 (UAS7) and monitor any side effects or adverse events throughout the study.
CONDITIONS
Brief 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...
- 18 years of age or older at screening
- Diagnosis of chronic spontaneous urticaria for 3 months or more
- Presence of itch and hives for at least 6 consecutive weeks despite using second generation antihistamines
- Use of second generation antihistamines at approved dose or higher for at least 7 consecutive days before screening
- Urticaria Activity Score 7 (UAS7) of 16 or higher and Itch Severity Score 7 (ISS7) of 8 or higher during the 7 days before randomization
- Completion of at least 5 Urticaria Activity Score eDiary entries in the 7 days before randomization
- Willingness to stop all other chronic spontaneous urticaria treatments except second generation antihistamines
- Both anti-Immunoglobulin E-naive and anti-Immunoglobulin E-experienced participants are eligible
- Anti-IgE-experienced participants must have stopped anti-IgE therapy at least 16 weeks before randomization
You will not qualify if you...
- Urticaria caused only by inducible urticaria
- Active skin diseases other than chronic urticaria that cause wheals or angioedema (eg, urticarial vasculitis, erythema multiforme, cutaneous mastocytosis, hereditary or acquired angioedema)
- Other active skin diseases causing chronic itching that could affect study results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus)
- History of severe allergic reaction to kinase inhibitors or allergy to study drug components
- History of systemic infection requiring hospitalization or parenteral therapy within 3 months before Day 1
- Active infections requiring treatment within 4 weeks before Day 1
- Untreated, treated inadequately, or latent tuberculosis infection
- History of disseminated herpes zoster or herpes simplex, or recurrent localized herpes zoster
- Infection with hepatitis B or C viruses
- Known immunodeficiency disorder or first-degree relative with hereditary immunodeficiency unless negative carrier status
- Severe or uncontrolled medical conditions including renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic, or neurologic diseases
- Hearing loss with progression in past 5 years or middle/inner ear diseases that are acute, fluctuating, or progressive
- Abnormal chest imaging findings including active tuberculosis, infections, cardiomyopathy, or malignancy
- History of malignancies except treated nonmetastatic basal or squamous cell skin cancer or cervical carcinoma in situ
- History of lymphoproliferative disorders or signs of lymphatic disease
- Major surgery or significant trauma within 1 month before first study dose
- Active suicidal ideation in past year or suicidal behavior in past 5 years
- Use of prohibited medications or treatments within defined timelines
- Participation in other investigational drug or vaccine studies within 8 weeks before first study dose
- Abnormal laboratory values or ECG findings that may affect safety or study results
- Investigator site staff and their family members, and sponsor employees involved in study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive daily capsules of Ritlecitinib or matching placebos for chronic spontaneous urticaria treatment.
Weekly visits for up to 12 weeks, then visits as scheduled through Week 24
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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