EUCTR2021-002166-40-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis with Inadequate Response to or for Whom Cyclosporine A is not Medically Advisable - A Multicenter trial to assess the safety and efficacy of nemolizumab in subjects with moderate-to-se
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma SA
- 入组人数
- 270
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. Subjects aged = 18 years at the screening visit.
- •2. Chronic AD for at least 2 years before the screening visit and confirmed according to American Academy of Dermatology Consensus
- •Criteria at the time of the screening visit.
- •3. EASI score = 20 at both the screening and baseline visits. Subjects with an EASI score of 18-19 at the screening visit only may be
- •reevaluated once within 48 hours.
- •4. IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
- •5. AD involvement = 10% of BSA at both the screening and baseline visits.
- •6. PP NRS score of at least 4.0 at the screening and baseline visit. The screening PP NRS score will be determined by a single PP NRS
- •assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit. The baseline PP NRS score
- •will be determined based on the average of the daily PP NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding
- •baseline (rounding is not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this
- •calculation.
- •7. Documented history of one of the following:
- •a. Previously exposed to CsA:
- •1) Inadequate response to CsA with previous exposure (defined as flare of AD during CsA tapering from a maximum of 6 weeks of high dose [5
- •mg/kg/day] to maintenance dose [2 to 3 mg/kg/day] or a flare after a minimum of 3 months on maintenance dose). Flare is defined as increase
- •in signs and/or symptoms leading to escalation of therapy (ie, increase in dose, switch to a higher-potency TCS, or start of another systemic
- •nonsteroidal immunosuppressive drug).
- •2) Previous requirement for CsA at doses > 5 mg/kg/day, or duration beyond those specified in the prescribing information (> 1 year).
- •3) Intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function tests, uncontrolled hypertension, paresthesia,
- •headache, nausea, hypertrichosis) with previous CsA exposure.
- •b. CsA is medically inadvisable:
- •1) medical contraindications (e.g. uncontrolled hypertension on medication).
- •2) use of prohibited concomitant medications (e.g. statins, digoxin, macrolide antibiotics, barbiturates, anti-seizure drugs, nonsteroidal antiinflammatory drugs, diuretics, angiotensin-converting-enzyme inhibitors, St John's Wort, etc.).
- •3) increased susceptibility to CsA-induced renal damage (elevated creatinine) and/or liver damage (elevated function tests).
- •4) increased risk of serious infections.
- •5) hypersensitivity to CsA active substance or excipients. Acceptable documentation includes patient records with information on CsA prescription and treatment outcome, other prohibitive medications/medical history, or written documentation of the conversation with the subject's treating physician, if different than the investigator, as applicable.
- •8. Documented history by a physician (within 6 months before the screening visit) of inadequate response to topical medications or use of systemic therapies for control of the disease. Inadequate response to
排除标准
- •1.Body weight < 30 kg.
- •2.One or more of the following criteria at screening or baseline:
- •a. Exacerbation of asthma requiring hospitalization in the preceding 12
- •b. Asthma that has not been well controlled (ie, symptoms occurring on > 2 days per week, nighttime awakenings 2 or more times per week, or
- •some interference with normal activities) during the preceding 3 months.
- •c. Asthma Control Test (ACT) = 19 (only for subjects with a history of asthma).
- •d. Peak expiratory flow (PEF) < 80% of the predicted value.
- •Note: In the event that PEF is < 80% of the predicted value at the screening visit, PEF testing can be repeated once within 48 hours:
- •For subjects without a history of asthma
- •For subjects with a history of asthma but if the ACT score is >19 at screening
- •3. Current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- •4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved.
- •Resolution of COVID-19 can be confirmed by recovery assessment methods, as described in the protocol.
- •Note: Subjects with chronic, stable use of prophylactic treatment forrecurrent herpes viral infection can be included in this clinical study.
- •5. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C [HCV] antibody with
- •positive HCV RNA, or human immunodeficiency virus [HIV] antibody) atthe screening visit.
- •Note: Subjects with a positive HBcAb and a negative HBsAg can be included if the hepatitis B surface antibody is positive (considered
- •immune after a natural infection). Subjects who are positive for HCV antibody and negative for HCV RNA may be enrolled.
- •In the event of rescreening, the serology tests results (eg, HBV, HCV, HIV) from the first screening can be used by the investigator to assess
- •the eligibility of rescreened subjects if those tests were performed within 6 weeks prior to the baseline visit.
- •6. Current active or latent tuberculosis (TB) infection or history of either untreated or inadequately treated active or latent TB according to the
- •local applicable guidelines. Note: Subjects who have a documented history of completion of an appropriate TB treatment regimen for latent or active TB with no history of re-exposure to TB since their treatment was completed are eligible to participate in the study.
- •In the event of rescreening, the TB test results from the first screening can be used by the investigator to assess the eligibility of rescreened
- •subjects if the test was performed within 6 weeks prior to the baseline visit.
- •7. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
- •8. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma,
- •squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence
- •in the last 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.
- •Full list of exclusion criteria is included within the protocol.
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