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

Part of paid clinical trials in New York, New York.

Sponsor
Ahuva D Cices
Study ID
NCT06795373
Phase
PHASE2
Status
Withdrawn

Conditions

  • CSU
  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ritlecitinib — DRUG
    Once daily dose of 100mg of ritlecitinib taken orally for 12 weeks

Study Details

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.

Key Dates

First listed
Jan 28, 2025
Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: persistent, progressive, or recurrent chronic spontaneous urticaria (CSU).
    Participants with persistent, progressive, or recurrent chronic spontaneous urticaria (CSU).

Primary Outcome Measure

Change in Urticaria Activity Score (UAS7) [ Time Frame: Baseline to Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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