EUCTR2024-000141-26-Outside-EU/EEA进行中（未招募）1 期
A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABROCITINIB 100 MG AND 200 MG TABLETS IN PARTICIPANTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS IN INDIA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
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
- •This study is seeking participants who:
- •1. Must be of 12 years of age or older, at the time of informed consent.
- •2. Meet all the following Atopic Dermatitis (AD) criteria:
- •i) Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed AD (Hanifin and Rajka criteria of AD).
- •ii) Moderate to severe AD (affected body surface area (BSA) =10%, Investigator's Global Assessment (IGA) =3, Eczema Area and Severity Index (EASI) =16, and Peak Pruritus Numerical Rating Scale (PP-NRS) =4 at the baseline visit);
- •iii) Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks), or who have required systemic therapies for control of their disease.
- •3. Negative pregnancy test for females of childbearing potential at Screening. Female participants of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of study intervention.
- •4. Body weight =25 kg at Baseline
- •5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Document (ICD) and in this protocol. Evidence of a personally signed and dated ICD indicating that the participant (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study. For minors under the age of legal consent in India, assent of the participating child needs to be documented for the age range 12 to 18 years in addition to the parental informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 156
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •This study does not include participants who:
- •1) Have active forms of other inflammatory skin diseases or have evidence of skin conditions eg., psoriasis
- •2) History of blood disorders, coagulation abnormalities, or QT interval irregularities.
- •3) Increased risk of venous thromboembolism, such as deep vein thrombosis or pulmonary embolism.
- •4) History of lymphoproliferative disorders, including EBV-related conditions, lymphoma, leukemia, or current symptoms of lymphatic diseases.
- •5) History or active infection with TB, disseminated herpes, HIV, Hepatitis B, or C.
- •6) Individuals with malignancies except for treated non- metastatic skin cancers or cervical carcinoma in situ.
- •7) 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 judgement, make the participant inappropriate for the study. Any psychiatric condition including recent or active suicidal ideation or behavior that met any of the following criteria when screened for during the main study:
- •i) 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);
- •ii) 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;
- •iii) Any lifetime history of serious or recurrent suicidal behavior;
- •iv) The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria;
- •v) In the opinion of the investigator or Pfizer (or designee) exclusion is required.
- •8. Prior treatment with systemic Jjanus Kkinase (JAK) inhibitors.
- •9. Participants who are vaccinated with live attenuated vaccine within the 6 weeks prior to the first dose of abrocitinib or who are expected to be vaccinated with these vaccines during treatment or during the 6 weeks following discontinuation of abrocitinib.
- •10. Have received any of the following treatment regimens specified in the timeframes outlined below:
- •Within 1 year of first dose of study intervention:
- •i) Prior treatment with non B cell-specific lymphocyte depleting agents/therapies (eg, alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc.). Participants who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal cluster of differentiation (CD) 19/20+ counts by fluorescence activated cell sorting (FACS) analysis.
- •Within 12 weeks of first dose of study intervention:
- •Biologic drugs that have immunomodulatory properties or could be used to treat AD: within 12 weeks of first dose of investigational product or 5 half-lives (if known), whichever is longer. Other biologics without immunomodulatory properties (eg, insulin) are permissible at the judgement of the Investigator.
- •Within 4 weeks of first dose of study intervention:
- •Use of oral immunosuppressive drugs (eg, Cyclosporine A (CsA), azathioprine, methotrexate, systemic corticosteroids, mycophenolate mofetil, Interferon gamma) within 4 weeks of first dose of study intervention or within 5 half-lives (if known), whichever is longer.
- •Within 1 week of first dose of study intervention:
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