EUCTR2019-004300-34-PL进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB WHEN USED IN COMBINATION WITH TOPICAL CORTICOSTEROID TREATMENT IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS - ADhere
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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. Adults and adolescents =12 to <18 years of age 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 (see Section 8.2.1).
- •5. =10% body surface area (BSA) of AD involvement at the baseline visit.
- •6. History of inadequate response to treatment with topical medications.
- •7. Applied a stable dose of non-medicated topical moisturizer at least twice daily for =7 days prior to the baseline visit.
- •8. Completed electronic diary entries for pruritus and sleep-loss for a minimum of 4 of 7 days preceding randomization.
- •9. Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
- •10. 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 or placebo.
- •NOTE: A woman of childbearing potential (WOCBP) 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 (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, 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.
- •11. 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
- •12. Provided signed informed consent/assent as described in Section 10.15.
- •13. Adolescent patients or their parents/caregivers who are willing and able to administer the study drug after training on proper injection techniques as required by this addendum.
- •14. Provide signed informed consent/assent to this addendum as described in Section 2.6.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •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 such as 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 rituximab, within 6 months.
- •d. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- •6. Use of 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 (defined by an ACQ-5 score =1.5 or a 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 cl
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