CTRI/2024/05/067846招募中3 期
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis.
Sanofi Healthcare India Pvt Limited8 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2024年6月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 8
- 主要终点
- To demonstrate the efficacy of amlitelimab monotherapy administered by subcutaneous (SC) injection in comparison to placebo in participants aged 12 years and older with moderate-to-severe atopic dermatitis (AD)
研究概览
简要总结
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate-to-severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate-to-severe AD aged 18 years and older. Study details include:• The study duration will be up to 28 weeks for participants entering the blinded extension study (EFC17600 [ESTUARY]) including a 2 to 4-week screening and a 24-week randomized double-blind period.• The study duration will be up to 44 weeks for participants not entering the blinded extension study (EFC17600 [ESTUARY]) including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.
• The total treatment duration will be up to 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1- Participants must be at least 12 years of age inclusive, at the time of the informed consent is signed.
- •2- Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria (2014) (47) for 1 year or longer at baseline.
- •3- Participant must have documented history within 6 months prior to screening visit, of either inadequate response or inadvisability of topical treatments.
- •4- EASI less than equal to 16 at baseline visit.
- •5- IGA of 3 or 4 at baseline visit (on the 0 to 4 IGA scale, IGA 3 and 4 for moderate and severe respectively).
- •6- AD involvement of 10% or more of BSA at baseline visit.
- •7- Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
- •This calculation shall include all reported values in the 7 days immediately preceding the baseline visit.
- •For participants who have not entered at least 4 daily PP-NRS during the 7 days immediately preceding the planned enrollment date, enrollment should be postponed until this requirement is met, but without exceeding the 28 day maximum duration for screening.
- •Must have applied topical bland emollient (moisturizer) at least once daily for a minimum of 5 out of 7 consecutive days before baseline visit.
- •Note: preferably additive free, basic bland emollient approved by the Investigator.
- •Participant may use prescription emollients or emollients containing additives (eg, urea) if such emollients were initiated before the screening visit.
- •9- Must demonstrate understanding and appropriate use of the e-diary and participant questionnaires, including collection of PP-NRS prior to baseline visit.
- •10- Able and willing to comply with requested study visits and procedures.
- •11- Body weight must be more than equal to 25 kg.
- •12- All participants-Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •13- Capable of giving a signed informed assent and or consent as described in Appendix 1 (Section 10.1) of the protocol which includes the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •The signed ICF must always be present at the time of inclusion.
排除标准
- •1- Skin co-morbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, lupus erythematosus) as per Investigators judgment.
- •2- Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •3- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
- •4- History of solid organ or stem cell transplant.
- •5- Any pre-planned major elective surgery known about at baseline visit that in the Investigator’s opinion would necessitate that IMP be permanently discontinued or require an interval greater than 12 weeks between doses.
- •6- Severe concomitant illness that would, in the Investigators opinion, inhibit the participants participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.
- •7- Any medical or psychiatric condition which, in the Investigators opinion may present an unreasonable risk to the study participants as a result of his her participation in this clinical study, may make participants participation unreliable, or may interfere with study assessments.
- •8- Presence of either of the following at Screening or Baseline Visits- 8a-active suicidal ideation or suicidal ideation in the past 6 months as indicated by a positive response (Yes) to Question 1, 2, or 3, of the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Questions.
- •8b-presence of active suicidal ideation with an intent andor plan or any lifetime history of suicidal ideation with an intent andor plan as indicated by a positive response (Yes) to Question 4 or 5 of C-SSRS Suicidal Ideation Questions.
- •8c- presence of active suicidal behavior or any lifetime history of suicidal behavior including suicide attempt (including actual attempt, interrupted attempt, or aborted attempt), preparatory acts for suicide attempt, or non-suicidal self-injurious behavior as indicated by a positive response (Yes) to any Suicide Behavior Questions of C-SSRS.
- •8d- assessment by the Investigator through participant interview and review of medical history of high risk of suicidal behavior.
- •9-Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections) and any infection which as per Investigators opinion precludes the participants participation in the study (including confirmed coronavirus disease 2019 [COVID 19] infection).
- •10- In the Investigators opinion, medical conditions related to prior AD medications that have not healedfully recovered for more than 2 weeks before Screening Visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis 11- Treatment with a live (attenuated) vaccine within 12 weeks prior to baseline, failure to complete non-live immunization required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
- •12- Prior use of any oral JAK inhibitor or topical ruxolitinib that exceeded 6 months.
- •13- Having received any of the following therapy (Table 9) within the specified timeframe(s) prior to the Baseline visit (unless otherwise specified) 14- Concurrent participation in any other clinical study, including non-interventional studies.
- •15- Participants positive for human immunodeficiency virus (HIV), participants with any of the following results at Screening (Visit 1)- presence of hepatitis B surface antigen (HBsAg) with or without hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) test or presence of antibody to hepatitis B core antigen (HBcAb) or presence of antibody to hepatitis B surface antigen (HBsAb) with positive HBV DNA PCR test, positive hepatitis C total antibody (HCVAb) confirmed by positive hepatitis C virus ribonucleic acid (HCV RNA).
- •16-Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, nontuberculous mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guerin (BCG)-vaccination within 12 weeks prior to screening 18- In the Investigators opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardiovascular condition that could preclude the participants participation in the study.
- •19-History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- •Known or suspected hypersensitivity to amlitelimab or excipients used in the presentation of amlitelimab or in preparation for administration.
- •20-Individuals accommodated in an institution because of regulatory or legal order, participants who are legally institutionalized, persons who have been placed in an institution on the basis of an official court order.
- •21- Any country-related specific regulation that would prevent the participant from entering the study.
- •22- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures 23- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the International Council for Harmonisation-Good Clinical Practice 24- Any anticipated situation during study implementation or course that may raise ethics considerations.
- •25- History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
结局指标
主要结局
To demonstrate the efficacy of amlitelimab monotherapy administered by subcutaneous (SC) injection in comparison to placebo in participants aged 12 years and older with moderate-to-severe atopic dermatitis (AD)
时间窗: Week 24
次要结局
- To assess the efficacy of amlitelimab monotherapy administered by SC injection in comparison to placebo in participants aged 12 years & older with moderate-to-severe AD.(Week 24)
研究者
研究点 (8)
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