Ritlecitinib for Chronic Urticaria

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must be taking: Second-generation antihistamines

Disqualifiers: Active skin diseases, Severe infections, Hepatitis, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

200 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

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

I have either never used anti-IgE therapy or stopped it at least 16 weeks ago due to various reasons.

I am at least 18 years old or the legal adult age in my area.

a. Chronic spontaneous urticaria diagnosis for ≥3 months at the time of screening (with the onset date assessed by the Investigator based on all available records) b. Diagnosis of CSU inadequately controlled by second generation antihistamine (sgAH) at the time of randomization, defined as: (i) The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgAH during this time period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period A

Participants receive either 50 mg or 100 mg of Ritlecitinib or placebo once daily for 12 weeks

12 weeks

Up to 5 visits (in-person)

Treatment Period B

Participants on 50 mg and 100 mg continue their doses; placebo group switches to 100 mg for an additional 12 weeks

12 weeks

Up to 4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Arm 2 Experimental Treatment 2 Interventions

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

Group II: Arm 1 Experimental Treatment 2 Interventions

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

Group III: Arm 3 Placebo Group 3 Interventions

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.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06795373

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-urticaria

Ritlecitinib (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).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07219615

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12105460/

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-urticaria

Pfizer'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 ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1346-8138.17886?af=R

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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39846397/

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-urticaria

A 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 ...