EUCTR2019-004301-28-PL进行中（未招募）1 期
AN OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE SAFETY AND EFFICACY OF LEBRIKIZUMAB IN ADOLESCENT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS - ADore
Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company0 个研究点目标入组 200 人开始时间: 2020年7月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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 or female adolescent (=12 years to <18 years and weighing =40 kg).
- •2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit (see Appendix 2).
- •3. Eczema Area and Severity Index (EASI) score =16 at the baseline visit.
- •4. Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit.
- •5. =10% body surface area (BSA) of AD involvement at the baseline visit.
- •6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- •7. Apply a stable dose of non-medicated, non-prescription moisturizer at least twice daily for =7 days prior to the baseline visit.
- •8. Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
- •9. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab.
- •NOTE: A woman of childbearing potential is defined as a postmenarcheal female, who has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- •NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- •10. Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of child-bearing potential
- •11. Provide signed informed consent/assent as described in Section 10.2.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in a prior lebrikizumab clinical study.
- •2. History of anaphylaxis as defined by the Sampson criteria (Sampson, 2006).
- •3. Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors (e.g., crisaborole) within 1 week prior to the baseline visit.
- •4. Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- •a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •b. Phototherapy and photochemotherapy (PUVA) for AD.
- •5. Treatment with the following prior to the baseline visit:
- •a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- •b. Dupilumab within 8 weeks.
- •c. B cell-depleting biologics, including to rituximab, within 6 months.
- •d. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- •6. Use of medicated prescription moisturizers within 7 days of the baseline visit.
- •7. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- •8. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- •9. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma (history of =2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for > 24 hours).
- •10. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves. 11. Evidence of active acute or chronic hepatitis (as defined by the Department of Health & Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.
- •12. Diagnosed active endoparasitic infections or at high risk of these infections.
- •13. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment.
- •14. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •15. In the Investigator’s opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests obtained at the screening visit.
- •16. Presence of skin comorbidities that may interfere with study assessments.
- •17. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- •18. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect the patient’s participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make pa
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