NL-OMON52148尚未招募3 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. - M-17923-30
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Almirall
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •1. Adults and adolescents (aged >=12 to <18 years at the time of ICF/IAF and
- •weighing >=40
- •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
- •5. >=10% BSA of AD involvement at the Baseline visit
- •6. Documented history by a physician of an inadequate response to existing
- •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 mid-potency
- •at least 4 weeks, or for the maximum duration recommended by the product
- •prescribing
- •information (eg, 14 days for high/very-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
- •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,
- •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
- •i. intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated
- •function test results, uncontrolled hypertension, paraesthesia, headache,
- •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
- •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
- 另有 2 项未显示
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 washout 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-γ, 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
- •b. B cell-depleting biologics, including but not limited to rituximab, within 6
- •c. Other biologics within 16 weeks or 5 half-lives (if known), whichever is
- •7. Treatment with a live (attenuated) vaccine within 12 weeks of the Baseline
- •visit, planned during the study, or 18 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/parlour 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
- •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
- •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,
- •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
- •14. Have known liver cirrhosis and/or chronic hepatitis of any aetiology
- •15. Diagnosed active endoparasitic infections or at high risk of these
- •16. Known or suspected history of immunosuppression, including history of
- •opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis,
- 另有 6 项未显示
研究者
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