EUCTR2020-000285-42-PL进行中（未招募）1 期
A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study with a 36–week Extension to Investigate the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis Despite Treatment with Topical Medications (The HILLIER Study) - HILLIER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female participants = 12 years of age at the time of signing the ICF.
- •2. Participants weighing = 35 kg at the time of signing the ICF.
- •3. Physician-confirmed diagnosis of AD (according to American Academy of Dermatology Consensus Criteria) that is not adequately controlled with topical medications.
- •4. EASI score of = 12 at screening and = 16 at randomization.
- •5. IGA score of = 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at screening and at randomization.
- •6. AD involvement of = 8% body-surface area at screening and = 10% body-surface area at randomization.
- •7. A pruritus numerical rating scale average score for maximum itch intensity of = 4, based on the average of daily pruritus numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization.
- •8. Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medications, or patients for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- •9. Participants that have applied a stable dose of topical emollient (moisturizer) twice daily for = 7 consecutive days immediately before the randomization visit. (NOTE: See exclusion criterion 23 for limitations regarding emollients)
- •10. Participants must be willing and able to complete daily PRO assessments:
- •(a)Complete at least 70% of daily PRO assessments between Visit 1 and Visit 2 and
- •(b)Complete at least 5 of 7 daily PRO assessments in the 7 days prior to Visit 2.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •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) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Participants with active dermatological conditions (eg, psoriasis, seborrheic dermatitis, cutaneous lymphoma) other than AD that, in the investigator’s opinion, may interfere with the study assessments.
- •2. Known active allergic or irritant contact dermatitis that, in the investigator’s opinion, may interfere with the study assessments.
- •3. Current malignancy, or history of malignancy, with the exception of:
- •(a) Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent/assent, was obtained.
- •(b) Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent/assent, was obtained.
- •4. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- •(a)Affect the safety of the participant throughout the study.
- •(b)Influence the findings of the studies or their interpretations.
- •(c)Impede the participant’s ability to complete the entire duration of study.
- •5. History of anaphylaxis to any biologic therapy or vaccine.
- •6. History of Guillain-Barré syndrome.
- •7. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent/assent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
- •8. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete entire duration of the study.
- •9. Current active liver disease:
- •(a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen or hepatitis C antibody), or other stable chronic liver disease are acceptable if participant otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis.
- •(b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level = 3 times the upper limit of normal, confirmed by repeated testing during the run-in period.
- •10. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
- •11. Participants who have received treatment for AD with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase-4 (PDE4) inhibitors within the 7 days prior to the randomization visit.
- •12. Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit).
- •13. Regular use (2 visits per week) of a tanning booth/parlor or phototherapy for AD within 4 weeks prior to the r
研究者
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