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
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.
∙ Participants are eligible to be included in the study only if all the following criteria apply:
• Participant has been informed about study procedures and medications and has provided informed consent prior to initiation of any study-specific activities/procedures
• Participant is able to communicate with the investigator, and understands and complies with the requirements of the study
• Age ≥ 18 to ≤ 65 years of age at screening
• Participant has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TBGold test (QFT) at screening or within the last 12 months.
• Chronic spontaneous urticaria diagnosis ≥ 3 months at the time of screening visit 1
• Diagnosis of CSU inadequately controlled by second-generation H1-antihistamines (sgAH) at enrollment, as defined by the following:
‣ The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to screening visit 2 despite current use of an approved dose of H1-antihistamine
⁃ Urticaria Activity Score over 7 days (UAS7) (range 0-42) ≥ 16 and Hive Severity Score over 7 days (HSS7) (range 0-21) ≥ 8 during the 7 days prior to enrollment
• Participant must have been on or failed a sgAH at approved or increased doses (up to 2 or 4x the approved dose) for treatment of CSU prior to the Baseline visit and must have documented current use on the day of screening visit ○ If participants are currently on a sgAH, they must continue the same dose throughout the trial