Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria

Phase 2

Recruiting

• Conditions: Chronic Spontaneous Urticaria; CSU
• Interventions: Drug: Ritlecitinib

• Registration Number: NCT06795373
• Lead Sponsor: Ahuva D Cices

Brief Summary

The purpose of this research study is to see if a drug called ritlecitinib is safe and effective for treating chronic spontaneous urticaria (CSU). CSU is hives and itching lasting over six weeks. Ritlecitinib is approved by the Food and Drug Administration (FDA) to treat another condition, but it is not approved for treating CSU. Participation is expected to last 20 weeks and include 7 clinic visits. This study will involve physical examinations, blood tests, looking at and taking pictures of participant's skin and hives, optional skin biopsies, and hearing tests. Eligible participants for this study will take ritlecitinib for 12 weeks and complete a daily diary about their skin and hives. The main risks of being in this study are side effects from ritlecitinib. Less than 1 in 10 people taking ritlecitinib experience diarrhea, acne, hives, rash, inflammation of hair follicles, dizziness, and increased blood levels of creatine phosphokinase (a muscle protein). Participants could also experience a rare but serious side effect, such as shingles, unusual infection, cancer, or blood clot. Benefits of participating in this study include a potential improvement in participant's condition and quality of life. Participating in this study may also help researchers develop new ways of helping future patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Study Start: 2025-02
• Primary Completion: 2026-05
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
persistent, progressive, or recurrent chronic spontaneous urticaria (CSU).	Ritlecitinib	Participants with persistent, progressive, or recurrent chronic spontaneous urticaria (CSU).

Primary Outcome Measures

Name	Time	Method
Change in Urticaria Activity Score (UAS7)	Baseline to Week 12	The UAS7 is calculated by adding up the daily UAS scores over a 7-day period. The score ranges from 0 to 42, with higher scores indicating more active disease.; Score Ranges: 0: Urticaria-free; 1-6: Well-controlled urticaria; 7-15: Mild urticaria; 16-27: Moderate urticaria; 28-42: Severe urticaria.

Secondary Outcome Measures

Name	Time	Method
Change in Angioedema Activity Score (AAS7)	Baseline to Week 2, 4, 8, and 16	Questionnaire used to measure the severity of angioedema symptoms over a 7-day period, where patients rate different aspects of their angioedema experience on a scale, with a higher score indicating greater disease activity; it is often used to assess the effectiveness of treatments for angioedema conditions like chronic spontaneous urticaria (CSU) or chronic histaminergic angioedema (CHA). Each day, patients rate different aspects of their angioedema (duration, severity, impact on daily activities) on a scale from 0 to 3, and the daily scores are summed over 7 days to get the AAS7 score. The score ranges from 0 to 105, with higher scores indicating more severe angioedema activity. Low Score (0-6): Indicates minimal angioedema activity Moderate Score (7-18): Represents moderate angioedema activity High Score (19-105): Shows severe angioedema activity
Percentage change of Health-Related Quality of Life (CU-Q2oL)	Baseline to Week 12	Survey that measures a patient's health-related quality of life (HR-QOL) in relation to chronic urticaria (CU). The CU-Q2oL is a 23-question survey that measures a patient's HR-QOL in relation to CU. The survey asks about a patient's sleep, concentration, energy levels, and how CU symptoms impact their daily life. The survey scores range from 1 (no complaints) to 5 (many complaints). which gives a total raw score from 0-115 which is then converted to provide Total score range from 0-100, with higher score indicating poorer health outcome.
Percentage of participants achieving 80% or greater improvement in Urticaria Activity Score (UAS7)	Baseline to Week 12	Percentage of participants achieving 80% or greater improvement in their weekly UAS7 score compare to baseline at week 12 and throughout the study. The UAS7 is calculated by adding up the daily UAS scores over a 7-day period. The score ranges from 0 to 42, with higher scores indicating more active disease.; Score Ranges: 0: Urticaria-free; 1-6: Well-controlled urticaria; 7-15: Mild urticaria; 16-27: Moderate urticaria; 28-42: Severe urticaria.
Percentage Change in Cohort Response Rate of Urticaria Activity Score (UAS7)	Baseline to Week 12	The UAS7 is calculated by adding up the daily UAS scores over a 7-day period. The score ranges from 0 to 42, with higher scores indicating more active disease.; Score Ranges: 0: Urticaria-free; 1-6: Well-controlled urticaria; 7-15: Mild urticaria; 16-27: Moderate urticaria; 28-42: Severe urticaria.
Change in Urticaria Control Test (UCT)	Baseline to Week 12	A 4 question survey with a 4 week recall to describe a patient's current health situation in relation to UC. Total score ranges from 0 -16, with higher score indicating better health outcomes. A score of 16 indicates complete disease control. A score of \<12 on the UCT identifies patients with poorly controlled chronic urticaria (CU), and a score of ≥12 identifies those with well-controlled symptoms. An improvement in 3 points is a minimal response, and an improvement of ≥6 points is a marked response.
Percentage change in Urticaria Activity Score (UAS7)	Baseline to Week 2, 4, 8, 12, and 16	The UAS7 is calculated by adding up the daily UAS scores over a 7-day period. The score ranges from 0 to 42, with higher scores indicating more active disease.; Score Ranges: 0: Urticaria-free; 1-6: Well-controlled urticaria; 7-15: Mild urticaria; 16-27: Moderate urticaria; 28-42: Severe urticaria.
Percentage change in Angioedema Activity Score (AAS7)	Baseline to Week 2, 4, 8, 12, and 16	Questionnaire used to measure the severity of angioedema symptoms over a 7-day period, where patients rate different aspects of their angioedema experience on a scale, with a higher score indicating greater disease activity; it is often used to assess the effectiveness of treatments for angioedema conditions like chronic spontaneous urticaria (CSU) or chronic histaminergic angioedema (CHA). Each day, patients rate different aspects of their angioedema (duration, severity, impact on daily activities) on a scale from 0 to 3, and the daily scores are summed over 7 days to get the AAS7 score. Low Score (0-6): Indicates minimal angioedema activity Moderate Score (7-18): Represents moderate angioedema activity High Score (19-105): Shows severe angioedema activity
Percentage of participants with Response of Urticaria Activity	Baseline to Week 12	Percentage of participants achieving complete response (CR: 100% improvement), partial response (PR: 50% to 99% reduction from the baseline UAS7 score), stable disease (SD: \<25% increase to \<50% clearance from baseline), and progressive disease (\>25% worsening above the baseline score) in skin at week 12 and throughout the study.
Change in Urticaria Activity Score (UAS7)	Baseline to Week 2, 4, 8, and 16	The UAS7 is calculated by adding up the daily UAS scores over a 7-day period. The score ranges from 0 to 42, with higher scores indicating more active disease.; Score Ranges: 0: Urticaria-free; 1-6: Well-controlled urticaria; 7-15: Mild urticaria; 16-27: Moderate urticaria; 28-42: Severe urticaria.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States