A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. (NCT07219615)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Saguaro Dermatology - Phoenix — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (69 Sites)
Showing the first 25 of 69 sites.
- Saguaro Dermatology - Phoenix — Phoenix, Arizona
- Acuro Research, Inc. — Little Rock, Arkansas
- Kern Research. Inc. — Bakersfield, California
- First OC Dermatology Research Inc — Fountain Valley, California
- Antelope Valley Clinical Trials — Lancaster, California
- Skin & Beauty Center - Pasadena — Pasadena, California
- Asthma and Allergy Associates, PC — Colorado Springs, Colorado
- Asthma and Allergy Center of Chicago — River Forest, Illinois
- Chesapeake Clinical Research — White Marsh, Maryland
- University of Michigan — Ann Arbor, Michigan
- Revival Research Institute, LLC — Troy, Michigan
- Allergy, Asthma, & Clinical Research Center — Oklahoma City, Oklahoma
- Orion Clinical Research — Austin, Texas
- RFSA Dermatology - San Antonio - West Avenue — San Antonio, Texas
- Complete Dermatology — Sugar Land, Texas
- Diagnostic Consultative Center Aleksandrovska — Sofia, Sofia (stolitsa)
- Medical Center Pulmo - 2018 EOOD — Haskovo,
- Diagnostic Consultative Center 1 - Pernik — Pernik,
- Diagnostic Consultative Center "Ascendent" — Sofia,
- Medical Center Hera EOOD — Sofia,
- Medical Center Pulmovision — Sofia,
- Laser Rejuvenation Clinics Edmonton D.T. Inc — Edmonton, Alberta
- CaRe Clinic — Red Deer, Alberta
- Allergy Centre Research — Mississauga, Ontario
- Allergy Research Canada Inc. — Niagara Falls, Ontario
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Spontaneous Urticaria
- Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. — CABA, Buenos Aires
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) — Cullman, Alabama
- 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up — Bakersfield, California
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria — Birmingham, Alabama
- An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib — Birmingham, Alabama
- Remibrutinib in Real-world Clinical Practice — Kirksville, Missouri
Explore by condition: All Chronic Spontaneous Urticaria clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.