A Single-center, Single-arm, Open-label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Urticaria Activity Score (UAS7)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
persistent, progressive, or recurrent chronic spontaneous urticaria (CSU).
Participants with persistent, progressive, or recurrent chronic spontaneous urticaria (CSU).
Intervention: Ritlecitinib (Drug)
Outcomes
Primary Outcomes
Change in Urticaria Activity Score (UAS7)
Time Frame: 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 Outcomes
- Change in Angioedema Activity Score (AAS7)(Baseline to Week 2, 4, 8, and 16)
- Percentage change of Health-Related Quality of Life (CU-Q2oL)(Baseline to Week 12)
- Percentage of participants achieving 80% or greater improvement in Urticaria Activity Score (UAS7)(Baseline to Week 12)
- Percentage Change in Cohort Response Rate of Urticaria Activity Score (UAS7)(Baseline to Week 12)
- Change in Urticaria Control Test (UCT)(Baseline to Week 12)
- Percentage change in Urticaria Activity Score (UAS7)(Baseline to Week 2, 4, 8, 12, and 16)
- Percentage change in Angioedema Activity Score (AAS7)(Baseline to Week 2, 4, 8, 12, and 16)
- Percentage of participants with Response of Urticaria Activity(Baseline to Week 12)
- Change in Urticaria Activity Score (UAS7)(Baseline to Week 2, 4, 8, and 16)
Investigators
Ahuva D Cices
Assistant Professor
Icahn School of Medicine at Mount Sinai