ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS - B7451064 (9002/0708)

Pfizer0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

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

年龄范围: 12 至 99（—）

入选标准

•Participants are eligible to be included in the study only if all of the
•following criteria apply:
•1. Participants 12 years of age or older at the time of signing the informed
•consent. Adolescent participants below the age of 18 years(or country -specific
•age of majority) will only be enrolled if approved by the country
•regulatory/health authority. If these approvals have not been granted, only
•participants 18 years of age (or country-specific age of majority) or older at
•the time of signing of informed consent may be enrolled.
•2. Participants who meet all of the following atopic dermatitis criteria:
•- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema)
•for at least 6months prior to Day 1 and has confirmed atopic dermatitis at the
•Screening and Baseline visits according to Hanifin and Rajka criteria for AD.10
•Refer to protocol. -Inadequate treatment options for moderate to severe AD due
•to history of inadequate response or intolerance to treatment with available
•approved medicated topical and systemic therapies for the treatment of AD,
•underlying conditions that preclude use of available approved medicated topical
•and systemic therapies for the treatment of AD, or lack of availability or
•access to approved medicated topical and systemic therapies for the treatment
•NOTE: Medicated topical therapy is defined as a topical product that contains
•an active pharmaceutical ingredient indicated for the treatment of AD
•(irrespective of whether it is an over the counter [OTC] or prescribed product).
•- Moderate to severe AD as indicated by meeting at least 1of the following on
•the day of the baseline visit: IGA >=3; EASI >=16.
•3. Participants who are ineligible for participation in any ongoing clinical
•trial of abrocitinib, including lack of access due to geographical limitations.
•4. Participants and, as applicable, parents/legal guardians of age of minority
•participants who are willing and able to comply with all scheduled visits,
•treatment plan, laboratory tests, lifestyle considerations, and other study
•procedures.
•5. Male or Female
•Contraceptive use by men or women should be consistent with local regulations
•regarding the methods of contraception for those participating in clinical
•studies. Refer to protocol.
•a. Male participants: No contraceptive measures are required.
•b. Female participants: A female participant is eligible to participate if she
•is not pregnant or breastfeeding, and at least one of the following conditions
•- Is not a woman of childbearing potential (WOCBP) (Refer to the definition in
•the Contraceptive Guidance appendix).
•- Is a WOCBP.A WOCBP who is sexually active must use a contraceptive method
•that is highly effective, with a failure rate of <1%, as described in
•Contraceptive Guidance appendix during the intervention period and for at least
•28 days after the last dose of abrocitinib. The investigator should evaluate
•the effectiveness of the contraceptive method in relationship to the first dose
•of abrocitinib.
•- A WOCBP must have a negative highly sensitive(refer to the Clinical
•Laboratory Tests appendix)serum pregnancy test at the Screening visit. A urine
•pregnancy test with a sensitivity of at least 25 mIU/mL, will be performed
•before the first dose of abrocitinib and a

排除标准

•Medical Conditions:
•1. Other medical or psychiatric condition including recent(within the past
•year)or active suicidal ideation/behavior or laboratory abnormality that may
•increase the risk of study participation or, in the investigator*s judgment,
•make the participant inappropriate for the study.
•2. The participant must have a risk assessment done by a qualified mental
•health professional (MHP) to assess whether it is safe to participate in the
•trial if the participant*s responses on any of the screening instruments or
•other information from the screening period indicate:
•- Suicidal ideation associated with actual intent and a method or plan in the
•past year for adults or at any time in their lifetime for adolescents ages >=12
•and <18years: *Yes* answers on items 4 or 5 of the Columbia Suicide Severity
•Rating Scale (C-SSRS).
•- Previous history of suicidal behaviors in the past 5 years for adults or at
•any time in their lifetime for adolescents ages >=12 and <18 years: *Yes* answer
•(in the past 5 years for adults or at any time in their lifetime for
•adolescents) to any of the suicidal behavior items of the C-SSRS.
•- Any lifetime history of serious or recurrent suicidal behavior (non-suicidal
•self-injurious behavior is not a trigger for a risk assessment unless in the
•investigator*s judgement it is indicated).
•- Clinically significant depression: Patient Health Questionnaire 8 items
•(PHQ-8) when the total score is>=15 for adults or>=10for adolescents ages >=12 and
•- The presence of any current major psychiatric disorder that is not explicitly
•permitted in the inclusion/exclusion criteria.
•- In the investigator*s judgment a risk assessment or exclusion is required.
•3. Have increased risk of developing venous thromboembolism, eg, deep vein
•thrombosis or pulmonary embolism:
•- History of venous thromboembolism, or
•- First-degree relative with unprovoked venous thromboembolism (ie, without
•known underlying cause such as trauma, surgery, immobilization, prolonged
•travel, pregnancy, hormone use, or plaster cast), that would suggest
•participant is at increased risk of inherited coagulation disorder (eg,Factor V
•4. A current or past medical history of conditions associated with
•thrombocytopenia, coagulopathy, or platelet dysfunction.
•5. Receiving anti-coagulants or medications known to cause thrombocytopenia
•(unless considered safe to stop and washout for the duration of the study).
•6. Have a history of any lymphoproliferative disorder such as Epstein Barr
•virus (EBV), related lymphoproliferative disorder, history of lymphoma,
•leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid
•7. Infection history:
•- Have a history of systemic infection requiring hospitalization, parenteral
•antimicrobial therapy, or as otherwise judged clinically significant by the
•investigator within 6months prior to Day1;
•- Have active chronic or acute skin infection requiring treatment with systemic
•antimicrobials within 2weeks prior to Day1, or superficial skin infections
•within 1week prior to Day1;
•- A participant known to be infected with human immunodeficiency virus (HIV),
•Hepatitis B, or Hepatitis C.
•Screening for Hepatitis B will include testing for hepatitis B surface
•antigen (HBsAg) and hepatitis B core antibody (H

研究者

发起方

Pfizer

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