A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS - B7451050 (9002/0605)

Pfizer0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 撤回
发起方: Pfizer
入组人数: 8

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: 18 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 must be 18 years of age or older inclusive, at the time of
•signing the informed consent.
•Type of Participant and Disease Characteristics
•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 1 year prior to Day 1 and has confirmed atopic dermatitis at the
•screening and baseline visits according to Hanifin and Rajka criteria for AD.
•Refer to Appendix 9.
•* Documented recent history (within 6 months before the screening visit) of
•inadequate response to treatment with medicated topical therapy for AD for at
•least 4 consecutive weeks, or who have required systemic therapies for control
•of their disease within the past year. 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 (BSA * 10%, IGA * 3, EASI * 16, and PP-NRS severity
•score * 4 on the day of the baseline visit).
•3. 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
•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 applies:
•* Is not a woman of childbearing potential (WOCBP) (see definition in Appendix
•* Is a WOCBP (all female participants, regardless of whether or not they have
•experienced/reported menarche, are considered WOCBP unless they are permanently
•sterile or confirmed infertile). A WOCBP who is sexually active must use a
•contraceptive method that is highly effective, with a failure rate of <1%,
•as described in Appendix 4 during the intervention period and for at least 28
•days after the last dose of study intervention. The investigator should
•evaluate the effectiveness of the contraceptive method in relationship to the
•first dose of study intervention.
•* A WOCBP must have a negative highly sensitive (Appendix 2) 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 study intervention
•and at every site visit including the EOT and follow-up visits to confirm the
•participant has not become pregnant. If a urine test cannot be confirmed as
•negative (eg, an ambiguous result), a serum pregnancy test is required. In such
•cases, the participant must be excluded from participation if the serum
•pregnancy result is positive.
•* The investigator is responsible for review of medical history, menstrual
•history, and recent sexual activity to decrease the risk for inclusion of a
•woman with an early undetected pregnancy.
•4. Capable of giving signed informed consent as described in Appendix 1 which
•includes compliance with the requirements and restrictions listed in the
•informed consent form (ICF) and in this protocol.
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排除标准

•Participants are excluded from the study if any of the following criteria apply:
•Medical Conditions
•1. Other acute or chronic medical condition including laboratory abnormality
•that may increase the risk associated with study participation or study
•intervention administration or may interfere with the interpretation of study
•results and, in the judgement of the investigator, would make the participant
•inappropriate for entry into this study.
•2. The participant should 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 screening information indicate:
•* Suicidal ideation associated with actual intent and a method or plan in the
•past year: *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: *Yes* answer (for
•events that occurred in the past 5 years) 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.
•* 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. A current or past medical history of conditions associated with
•thrombocytopenia, coagulopathy, or platelet dysfunction.
•4. Receiving anti-coagulants or medications known to cause thrombocytopenia
•(unless considered safe to stop and washout for the duration of the study).
•5. Currently have active forms of other inflammatory skin diseases (ie, not AD)
•or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis,
•Lupus) at the time of Day 1 that would interfere with evaluation of AD or
•response to treatment.
•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 6 months prior to Day 1;
•* Have a known helminth infection;
•* Have active chronic or acute skin infection requiring treatment with systemic
•antimicrobials within 2 weeks prior to Day 1, or superficial skin infections
•within 1 week prior to Day 1;
•* A participant known to be infected with human immunodeficiency virus (HIV),
•Hepatitis B, or Hepatitis C.
•* Participants who are hepatitis B surface antigen (HBsAg) negative, hepatitis
•B core antibody (HBcAb) positive, and hepatitis B surface antibody (HBsAb)
•positive at Screening will have reflex testing for hepatitis B Virus (HBV)
•deoxyribose nucleic acid (DNA). Participants who have HBV DNA above the lower
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研究者

发起方

Pfizer

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