2023-506548-18-00招募中3 期
A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis
Sanofi-Aventis Recherche & Developpement117 个研究点 分布在 10 个国家目标入组 410 人开始时间: 2024年1月8日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 410
- 试验地点
- 117
- 主要终点
- Percentage of participants who experienced treatment-emergent adverse event (TEAE)
研究概览
简要总结
Characterize the safety of long-term treatment with amlitelimab in participants with atopic dermatitis (AD)
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
- •Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. -- Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feederparent study SFY17915, INT18404, EFC17599, or EFC17600 --Participants in DRI17366 must only be enrolled from 1 of the following 3 groups: --- The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥
- •-- The second group: participants entering LTS17367 between Week 28 and Week 52 of the feederparent study, due to loss of clinical response in the part 2 of the feederparent study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or
- •For DRI17366 loss of clinical response is defined as the first instance of < EASI 50 during the second study period and where rescue therapy is no longer permitted. --- The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up or thereafter -- Participated in DRI17366 completing the previous study safety follow up (week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
- •Provide signed informed consent and able to comply with the requirements of the protocol
- •Complied with the previous clinical trial protocol to the satisfaction of the investigator
- •Body weight must be ≥25 kg
排除标准
- •Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol
- •Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator’s judgment
- •Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make particpant’s participation unreliable, or may interfere with study assessments
- •In the Investigator’s opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis
- •Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
- •History of solid organ or stem cell transplant
- •Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
- •Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA
- •History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- •Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB 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-Guérin (BCG)-vaccination within 12 weeks prior to screening
- •Participants with an determinate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met: a) Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection b) Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant c) For whom review and approval from Sponsor have been granted are eligible
- •Severe concomitant illness that would in the Investigator’s opinion inhibit the participant’s participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Percentage of participants who experienced treatment-emergent adverse event (TEAE)
Percentage of participants who experienced treatment-emergent adverse event (TEAE)
次要结局
- Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)
- Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)
- Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
- Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
- Proportion of participants with EASI50/EASI75/EASI90 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24
- Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24
- Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]
- Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]
- Proportion of participants with EASI50/ EASI75/EASI90 in all participants entering the study [each LTS17367 visit]
- Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment
- Serum amlitelimab concentration assessed at prespecified time points through the end of the study
- Number of participants with anti drug antibodies (ADAs) of amlitelimab at specified timepoints
- Percentage of participants who experienced TEAE leading to treatment discontinuation
- Proportion of participants with vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit
- Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit]
- Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study
- Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)
- Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit]
- Proportion of participants with vIGA-AD score 0 [each LTS17367 visit]
- Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment
- Number of days on topical medication (per patient-year) in all participants entering the study
- Change coming from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit]
- Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit]
- Change from feeder study baseline^ in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit]
- Change from feeder study baseline in BSA-AD [each LTS17367 visit]
- Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA)
- Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Research & Development
研究点 (117)
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