Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07219615 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
A Phase 2 study of Chronic Spontaneous Urticaria, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT07219615 is a Phase 2 study of Chronic Spontaneous Urticaria that is actively recruiting participants, run by Pfizer. The registered enrollment target is 200 participants, below the 1,416-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT07219615, a Phase 2 study of Chronic Spontaneous Urticaria, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,416-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (86% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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.
NCT07219615 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Oklahoma.
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.
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).
Who is sponsoring clinical trial NCT07219615?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)
RECRUITING · Phase 2
-
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
RECRUITING · Phase 2
-
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
COMPLETED · Phase 2
-
Remibrutinib in Real-world Clinical Practice - a US Sub-study
RECRUITING
-
Remibrutinib in Real-world Clinical Practice
RECRUITING
-
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
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.