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A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
NCT07219615 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Ritlecitinib 50 mg
- DRUG Ritlecitinib 100 mg
- DRUG Placebo - 50 mg
- DRUG Placebo - 100 mg
Study Locations (2)
Michigan
- Revival Research Institute, LLC — Troy
Oklahoma
- Allergy, Asthma and Clinical Research — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-10-30 |
| Est. Completion | 2027-04-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07219615
The ClinicalTrials.gov registry entry for NCT07219615 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 4 interventions — of which Ritlecitinib 50 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07219615 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Michigan, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07219615 about?
NCT07219615 is a clinical study titled "A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.". 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...
What is the current status of trial NCT07219615?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-10-30. Estimated completion is 2027-04-23.
What conditions does trial NCT07219615 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07219615?
The interventions under investigation include: Ritlecitinib 50 mg (DRUG), Ritlecitinib 100 mg (DRUG), Placebo - 50 mg (DRUG), Placebo - 100 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07219615?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07219615 being conducted?
This trial has 2 study locations across Michigan, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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