Testing Ritlecitinib against a placebo for chronic spontaneous urticaria

Exclusion

• −History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
• −Infected with hepatitis B or hepatitis C viruses: all participants will undergo screeningScreeningThe checks done before joining, to see whether a study fits.Read more → for hepatitis B and C for eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →.
• −Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency (unless known negative carrier status).
• −Medical Conditions:
• −Medical conditions pertaining to CSU and other diseases/conditions affecting the skin
• −Urticaria is solely due to inducible urticaria.
• −Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms, including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to Complement 1 (C1) inhibitor deficiency).
• −Any other active skin disease associated with chronic itching that might influence, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigold, dermatitis herpetiformis, senile pruritus, etc.).
• −General Infection History:
• −Having a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
• −Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1.
• −Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
• −Specific Viral Infection History
• −History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
• −Other Medical Conditions
• −Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hyperthyroidism or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements.
• −Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive.
• −Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening.
• −Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• −Have a history of any lymphoproliferative disorder such as Epstein-Barr Virus (EBV)-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
• −Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Any psychiatric condition including recent or active suicidal ideation or behavior that protocolProtocolThe detailed plan a study must follow.Read more →-defined criteria.
• −Prior/Concomitant Therapy:
• −Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol defined timelines.
• −Prior/Concurrent Clinical Study Experience:
• −Previous administration of an investigational product (drug or vaccine) within 8 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
• −Diagnostic Assessments:
• −Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
• −Screening standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
• −Other Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −Investigator siteTrial siteA hospital or clinic where a study is actually run.Read more → staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsorSponsorThe organisation responsible for the study overall.Read more → and sponsor delegate employees directly involved in the conduct of the study and their family members.
• −Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery. Participants with elective surgery scheduled to occur during the study can only be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → with approval of the sponsor.