EUCTR2021-002967-23-ES进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable. - ADvantage
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 312
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 (aged =12 to <18 years at the time of ICF/IAF and weighing =40kg)
- •2. Chronic AD (according to Hanifin and Rajka Criteria 2) that has been present for =1 year before the Screening visit
- •3. EASI score =16 at the Baseline Visit
- •4. IGA score =3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit
- •5. =10% BSA of AD involvement at the Baseline visit
- •6. Documented history by a physician of an inadequate response to existing topical medications within 6 months before Screening, defined as: inability to achieve good disease control (eg, not able to achieve IGA =2) after use of at least a moderate-potency TCS for
- •at least 4 weeks, or for the maximum duration recommended by the product prescribing information (eg, 14 days for ultra-high-potency TCS), whichever is shorter
- •7. Documented history by a physician of either:
- •a) No previous CsA exposure and not currently a candidate for CsA treatment because of
- •i. medical contraindications (eg, uncontrolled hypertension on medication), or
- •ii. use of prohibited concomitant medications (eg, statins, digoxin, macrolide antibiotics, barbiturates, anti-seizure drugs, nonsteroidal anti-inflammatory drugs, diuretics, angiotensin-converting-enzyme inhibitors, St John’s Wort, etc.), or
- •iii. increased susceptibility to CsA-induced renal damage (elevated creatinine) and/or liver damage (elevated function tests results), or
- •iv. increased risk of serious infections, or
- •v. hypersensitivity to CsA active substance or excipients
- •b) Previous exposure to CsA; CsA treatment should not be continued or restarted because of:
- •i. intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function test results, uncontrolled hypertension, paraesthesia, headache, nausea, hypertrichosis); or
- •ii. requirement for CsA at doses or durations beyond those specified in the prescribing information or inadequate response
- •8. Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before randomisation
- •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 to use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo
- •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 WOCBP
- •12. Patient must provide signed ICF. Adolescent patients must also provide separate informed assent to enrol in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 39
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 312
- •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. Treatment with IL-4 or IL-13 antagonists biological therapies before the Baseline visit.
- •Exception: previous treatment with dupilumab will be allowed in a subset of patients. A wash-out of at least 8 weeks before the Baseline visit will be required for this subpopulation
- •3. Treatment with TCS within 1 week before the Baseline visit
- •4. Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit
- •5. Treatment with any of the following agents within 4 weeks before the Baseline visit:
- •a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-?, JAK inhibitors, azathioprine, methotrexate, etc.)
- •b. Phototherapy and photochemotherapy (PUVA) for AD
- •6. Treatment with the following before the Baseline visit:
- •a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer;
- •b. B cell-depleting biologics, including but not limited to rituximab, within 6 months;
- •c. Other biologics within 16 weeks or 5 half-lives (if known) , whichever is longer
- •7. Treatment with a live (attenuated) vaccine within 12 weeks of the Baseline visit, planned during the study, or 12 weeks after the study treatment is discontinued
- •8. History of anaphylaxis as defined by the Sampson criteria 40
- •9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the Screening visit
- •10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-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 hospitalisation for >24 hours)
- •11. Have had any of the following types of infection within 3 months of Screening or develop any of these infections before randomisation:
- •a. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment);
- •b. Opportunistic (as defined in Winthrop et al. 2015). NOTE: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over;
- •c. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
- •d. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis)
- •12. Have a current or chronic infection with hepatitis B virus
- •13. Have a current infection with hepatitis C virus (ie, positive for hepatitis C RNA)
- •14. Have known liver cirrhosis and/or chronic hepatitis of any etiology
- •15. Diagnosed active endoparasitic infections or at high risk of these infections
- •16. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent,
- •recurrent, or prolonged infections, per the Investigator’s judgment
- •17. History of HIV infection or positive HIV serology at Screening
- •18. In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry, haematology, or urinalysis tests obtained at the Screening visit
- •19. Presence of skin comorbidities that may interfere with study assessments
- •20. History of malignancy, including mycosis fungoides, within 5 years before
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