Ritlecitinib for Chronic Urticaria
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine called ritlecitinib to determine its safety and effectiveness in treating chronic hives (itchy welts and swelling) that do not respond to regular allergy medicine. Participants will receive either a low dose, a high dose, or a placebo (a pill with no active ingredients) to compare the effects. Adults who have had chronic hives for three months or more, which have not improved with antihistamines, may be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You will need to stop all other treatments for chronic spontaneous urticaria except for a second-generation antihistamine.
Is there any evidence suggesting that ritlecitinib is likely to be safe for humans?
Research shows that ritlecitinib is generally well-tolerated. In previous studies, many participants reported mild to moderate side effects, with the most common being colds, headaches, upper respiratory infections, and diarrhea. About 86.1% of participants experienced some side effects, but most were not serious.
These findings contribute to understanding the safety of ritlecitinib. As this trial is in an early phase, the treatment remains under close study for safety and effectiveness. However, past data suggests that serious problems are rare, and participants in earlier trials managed the side effects well.12345Why do researchers think this study treatment might be promising for chronic urticaria?
Ritlecitinib is unique because it targets the Janus kinase (JAK) pathway, which plays a crucial role in the inflammatory process of chronic urticaria. Unlike traditional treatments like antihistamines and corticosteroids that mainly address symptoms, Ritlecitinib works at the source of inflammation, potentially providing more effective long-term relief. Researchers are excited about its potential to offer a targeted approach with fewer side effects, making it a promising option for those who don't respond well to existing therapies.
What evidence suggests that ritlecitinib might be an effective treatment for chronic spontaneous urticaria?
Studies have shown that ritlecitinib can effectively treat chronic spontaneous urticaria (CSU), a condition that causes itchy hives and swelling. One study found that 23% of patients taking a 50 mg dose of ritlecitinib experienced significant improvement, compared to just 2% of those taking a placebo. This trial will evaluate different dosages of ritlecitinib, with participants receiving either a 50 mg or 100 mg dose, or a placebo. Ritlecitinib targets specific parts of the immune system, potentially calming the body's overactive "allergy alarm system." Initial findings suggest it is a promising option for those struggling with CSU.14678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Adults diagnosed with chronic spontaneous urticaria (CSU) for at least 3 months, uncontrolled by antihistamines. Participants must be over 18, without other skin conditions causing itchiness or reactions to known triggers. They should not be on any CSU treatments except second-generation antihistamines and have a certain level of disease activity as measured by specific scores.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period A
Participants receive either 50 mg or 100 mg of Ritlecitinib or placebo once daily for 12 weeks
Treatment Period B
Participants on 50 mg and 100 mg continue their doses; placebo group switches to 100 mg for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ritlecitinib
Trial Overview
The trial is testing Ritlecitinib's safety and effectiveness in two doses (50 mg and 100 mg) against a placebo for treating CSU when antihistamines fail. It involves random assignment to one of the doses or placebo for 12 weeks, then an additional period where placebo participants switch to the active drug.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Randomized to Ritlecitinib 100 mg for 24 weeks (Periods A and B). In addition to the active Ritlecitinib 100 mg capsule, a placebo matching the Ritlecitinib 50 mg capsule will be given to maintain blind
Randomized to Ritlecitinib 50 mg for 24 weeks Periods A and B). In addition to the active Ritlecitinib 50 mg capsule, a placebo matching the Ritlecitinib 100 mg capsule will be given to maintain blind
Randomized to placebos matching the Ritlecitinib 50 mg and Ritlecitinib 100 mg capsules will be given to maintain blind from Day 1 to Week 12 (Period A). From Week 12 to Week 24 (Period B), will be switched to Ritlecitinib 100 mg. In addition to the active Ritlecitinib 100 mg capsule, a placebo matching the Ritlecitinib 50 mg capsule will be given to maintain blind.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Study Details | NCT06795373 | Ritlecitinib (PF-06651600) ...
The purpose of this research study is to see if a drug called ritlecitinib is safe and effective for treating chronic spontaneous urticaria (CSU).
2.
mountsinai.org
mountsinai.org/clinical-trials/ritlecitinib-pf-06651600-in-participants-with-chronic-spontaneous-urticariaRitlecitinib (PF-06651600) in Participants With Chronic ...
The purpose of this research study is to see if a drug called ritlecitinib is safe and effective for treating chronic spontaneous urticaria (CSU).
NCT07219615 | A Study to Learn About Ritlecitinib for the ...
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic ...
Long‐term safety and efficacy of ritlecitinib in adults ...
In ALLEGRO‐2b/3, 23% of patients who received ritlecitinib 50 mg daily (QD), compared with 2% in the placebo group, achieved the primary endpoint of SALT ≤20 at ...
5.
tipranks.com
tipranks.com/news/company-announcements/pfizers-new-study-on-ritlecitinib-a-potential-game-changer-for-chronic-urticariaPfizer's New Study on Ritlecitinib: A Potential Game ...
' The study aims to assess the safety and effectiveness of ritlecitinib for treating chronic spontaneous urticaria (CSU), a condition ...
Safety Assessment of Ritlecitinib Based on the FDA ...
The common adverse events (AEs) of ritlecitinib were nasopharyngitis (9.9%), headache (9.3%), upper respiratory tract infection (8.4%), diarrhea ...
Long-term safety and efficacy of ritlecitinib in adults ...
86.1% of patients reported treatment-emergent adverse events (AEs); most were mild or moderate in severity, with the most frequent being ...
8.
trial.medpath.com
trial.medpath.com/clinical-trial/9b19a50a3c773bca/nct07219615-ritlecitinib-pf-06651600-chronic-spontaneous-urticariaA Study to Learn About Ritlecitinib for the Potential Treatment ...
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic ...
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