EUCTR2020-001509-21-PL进行中（未招募）1 期
A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF 06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 71
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Have a clinical diagnosis of AA and =25% scalp hair loss (including AT and AU) due to AA.
- •2.Have normal hearing and BAEP assessments at screening.
- •3.Have a normal neurological examination by a neurologist at screening (unilateral carpal tunnel syndrome or median nerve neuropathy permitted).
- •4.Male or female (not pregnant or breastfeeding) subjects between18 to 50 years.
- •5.Female (not pregnant or breastfeeding) participants must be either be a WOCBP and using a highly effective contraceptive method or not be of childbearing potential (WOCBP).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior.
- •2.Any current hearing loss or current disease that can affect hearing.
- •3.Current or history of clinically significant central or peripheral neurological disease
- •4.First degree family history of hereditary neuropathy.
- •5.Any history of peripheral neuropathy (PN), including diabetic PN, chemotherapy-induced PN, drug-induced PN, genetic PN, idiopathic PN, etc.
- •6.Current or recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease and parathyroid disease, which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic (other than AA), rheumatologic, dermatologic 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
- •7.Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •8.History of any lymphoproliferative disorder.
- •9.History of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
- •10.History of systemic infection requiring hospitalization, parenteral antimicrobial therapy within 6 months prior to Day 1
- •11.Known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
- •12.History of HIV or positive serology for human immunodeficiency virus (HIV) at screening.
- •13.Considered in imminent need for surgery.
- •14.Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1
- •15.Infection with hepatitis B or hepatitis C viruses.
- •16.Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
- •17.Abnormal findings on the screening chest radiographs (eg, chest x-ray) including, but not limited to, presence of active TB, infection, cardiomyopathy, or malignancy.
研究者
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