2024-519370-40-00招募中3 期
B7981094 - A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO‑CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 74
- 试验地点
- 22
- 主要终点
- SALT ≤20 response at Week 24
研究概览
简要总结
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on regrowth of scalp hair
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled.
- •Must meet the following AA criteria at both Screening and Baseline: a. Have a clinical diagnosis of AA with no other etiology of hair loss. b. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months. •Photographs taken at Screening must be submitted to the Sponsor’s designee for verification of SALT score ≥50 and hair loss due to AA. Participants must not be randomized until verification has been confirmed. c. Current episode of hair loss ≤10 years.
排除标准
- •Diseases or conditions affecting hair loss
- •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.
- •Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria: •Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the C-SSRS administered at the Screening visit (see Section 8.3.10). •Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS. •For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior.
- •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
- •Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB.
- •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. • Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility. • 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).
- •Other Medical Conditions: •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. Documentation of the official reading must be located and available in the source documentation. •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 EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. •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 enrolled with approval of the sponsor.
- •Adolescent participants 12 to <18 years of age without one of the following: •Documented evidence from a health professional of having received varicella vaccination (2 doses); or •Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening. Note: Serological testing must be performed for VZV immunoglobulin G (IgG) antibody (Ab) only in the absence of documented evidence from a health professional of having received varicella vaccination (2 doses). If serological testing is performed in the presence of documented evidence of having received varicella vaccination (2 doses), participants are eligible to enter the study regardless of the result of serological testing.
- •Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
结局指标
主要结局
SALT ≤20 response at Week 24
SALT ≤20 response at Week 24
次要结局
- SALT ≤20 response at Week 24
- PGI-C response, defined as a score of “moderately improved” or “greatly improved” at Week 24
- CFB in SALT score at Week 24
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (22)
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