EUCTR2021-002344-73-DE进行中（未招募）1 期
A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 315
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
- 性别
- All
入选标准
- •- Participant must be 18 years of age, inclusive, or older at the time of
- •signing the informed consent.
- •- Participated in KY1005-CT05 (DRI17366) for moderate to severe AD
- •and received study treatment, adequately completed the assessments
- •required for the treatment period. Participants must only be enrolled
- •from 1 of the following 3 groups:
- •-- The first group: participants at Week 24 in the KY1005-CT05
- •(DRI17336) study who have not achieved an = Eczema Area and Skin
- •Severity Index (EASI)-75 and are Investigator Global Assessment (IGA)
- •2, 3 or 4.
- •-- The second group: participants entering the LTE between Week 28 and Week 52 of the parent study, due to loss of clinical response in the part 2
- •of the parent study. Loss of clinical response is defined as the first
- •instance of < EASI-50 during the second study period.
- •-- The third group: participants at Week 24 in KY1005-CT05 (DRI17336)
- •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
- •- Provide signed informed consent and able to comply with the
- •requirements of the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Participants are excluded from the study if any of the following criteria
- •- Any participant who has received prohibited systemic therapies, as per
- •KY1005-CT05 (DRI17366) clinical trial protocol, either during or after
- •completion of KY1005-CT05 (DRI17366) will not be eligible for the longterm extension (LTE)
- •- Participants who, during their participation in KY1005-CT05
- •(DRI17366), developed an adverse events (AE) or a serious adverse
- •event (SAE) deemed related to amlitelimab, which in the opinion of the
- •Investigator could indicate that continued treatment with amlitelimab
- •may present an unreasonable risk for the participant
- •- Conditions in KY1005-CT05 (DRI17366), consistent with protocoldefined criteria for permanent IMP discontinuation, if deemed related to
- •amlitelimab or led to Investigator or Sponsor-initiated withdrawal of
- •participant from the study (e.g., non-compliance, inability to complete
- •study assessments, etc.).
- •- Developed a medical condition that would preclude participation as per
- •KY1005-CT05 (DRI17366) clinical trial protocol
- •- Concurrent participation in any other clinical study, including noninterventional studies
- •- Only in those participants entering after completion of KY1005-CT05
- •(DRI17366) safety follow-up
- •a) Newly diagnosed Tuberculosis (TB) or non-TB mycobacterial
- •infections requiring treatment (including a positive QuantiFERON®-TB
- •Gold blood test at the screening visit),
- •b) Positive for human immunodeficiency virus (HIV), hepatitis B surface
- •antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C
- •antibody (HCV Ab) at the screening visit.
- •c) Laboratory values at the Screening Visit:
- •i) Serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and >
- •1.9 mg/dL (168 µmol/L) in male patients,
- •ii) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •>2.0 x upper limit of normal (ULN),
- •iii) Serum total bilirubin >1.5 x ULN (except for subjects with Gilbert's
- •syndrome, where total bilirubin must not exceed 3.0 mg/dL or 50
- •iv) In the Investigator's opinion, any additional clinically significant
- •laboratory results from the clinical chemistry, haematology or urinalysis
- •tests at the Screening visit.
- •d) In the Investigator's opinion any significant abnormality on 12-lead
- •ECG at the screening visit.
- •- History of or known or suspected hypersensitivity to amlitelimab or the
- •matching placebo formulation, or excipients used in the presentation of
- •amlitelimab or placebo, or in preparation for administration. History of
- •or known or suspected severe hypersensitivity reactions to other mAbs
- •and/or their excipients.
研究者
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