EUCTR2015-000595-10-DE进行中（未招募）1 期
A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Written informed consent and any locally required authorization (eg, Health Insurance
- •Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data
- •Privacy Directive in the EU) obtained from the subject prior to performing any protocolrelated
- •procedures, including screening evaluations.
- •2. Age 18-75 years inclusive at the time of Screening
- •3. Current disease state meeting the Hanifin and Rajka, 1980 criteria for AD (see Appendix 5)
- •4. Atopic dermatitis that affects = 10% body surface area at Visit 1 (Screening), as assessed
- •5. A IGA score of = 3 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- •6. An EASI score of = 12 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- •7. A SCORAD of = 20 at Visit 1 (Screening)
- •8. No clinically significant abnormality on the basis of medical/medication history or
- •physical examination
- •9. If on allergen-specific immunotherapy, subjects must be on a maintenance dose and
- •schedule for = 1 month prior to Visit 1 (Screening). Allergen-specific immunotherapy
- •refers to subcutaneous immunotherapy to aeroallergens and/or venom (Hymenoptera) as
- •well as sublingual immunotherapy to aeroallergens.
- •10. Able and willing to comply with the requirements of the protocol
- •11. Females of childbearing potential who are sexually active with a nonsterilized male
- •partner must use highly effective contraception from enrollment (after written informed
- •consent is obtained) and must agree to continue using such precautions through to the end
- •of the study; cessation of birth control after this point should be discussed with a
- •responsible physician. Periodic abstinence, the rhythm method, and the withdrawal
- •method are not acceptable methods of birth control. Females of childbearing potential are
- •defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral
- •oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of
- •contraception is defined as one that results in a low failure rate (ie, less than 1% per year)
- •when used consistently and correctly (Table 4.1.2-1).
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Active dermatologic conditions, which may confound the diagnosis of AD or would
- •interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous
- •lymphoma, ichthyosis, or psoriasis
- •2. Known active allergic or irritant contact dermatitis
- •3. History of a clinically significant infection within 4 weeks prior to Visit 3 (Week 0,
- •Day 1) which, in the opinion of the investigator or medical monitor, may compromise the
- •safety of the subject in the study, interfere with evaluation of the investigational product,
- •or reduce the subject’s ability to participate in the study. Clinically significant infections
- •are defined as:
- •? A systemic infection or
- •? A serious skin infection requiring parenteral antibiotics, antiviral, or antifungal
- •medication.
- •4. Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not
- •been treated with, or has failed to respond to standard of care therapy
- •5. History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix
- •treated with apparent success with curative therapy = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to
- •Visit 1 (Screening)
- •6. History of chronic alcohol or drug abuse within 12 months prior to screening, or any
- •condition associated with poor compliance as judged by the investigator
- •7. Pregnant or breastfeeding women or pregnancy planned within the next 6 months from
- •8. Use of tanning beds or phototherapy within 8 weeks of Visit 3 (Week 0, Day 1)
- •9. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives
- •prior to Visit 3 (Week 0, Day 1), whichever is longer
- •10. Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to
- •Visit 3 (Week 0, Day 1), whichever is longer
- •11. Treatment with the following medications within the last 4 weeks prior to Visit 3
- •(Week 0, Day 1):
- •a. Systemic immunosuppressive/immunomodulating drugs (eg, methotrexate,
- •cyclosporine, azathioprine, mycophenolate mofetil, tacrolimus, interferon ?)
- •b. Immunoglobulin and/or blood products
- •c. Systemic corticosteroids (topical, inhaled, or intranasal delivery are permitted)
- •d. Topical calcineurin inhibitor use
- •12. Subjects who have received a live or attenuated vaccine within 4 weeks prior to Visit 3
- •(Week 0, Day 1). Receipt of inactive/killed vaccinations (eg, inactive influenza) is
- •allowed provided they are not administered within 1 week before/after any study visit.
- •13. Receipt of the Th2 cytokine inhibitor suplatast within 15 days prior to Visit 1 (Screening)
- •14. Known history of allergy or reaction to any component of the investigational product
- •formulation
- •15. History of anaphylaxis following any biologic therapy
- •16. Subjects who are intolerant or contraindicated to use study-mandated TCS for lesional
- •17. Any clinically relevant abnormal findings in physical examination ECG, vital signs,
- •hematology, clinical chemistry, or urinalysis during screening, which in the opinion of
- •the investigator or medical monitor may compromise the safety of the subject in the study
- •or interfere with evaluation of the investigational product or reduce the subject’s ability
- •to participate in the study
- •18. Evidence of active liver disease, including jaundice or aspartate transaminase (AST),
- •alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit o
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