E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012438 |
E.1.2 | Term | Dermatitis atopic |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Characterize the safety of long-term treatment with amlitelimab in participants with atopic dermatitis (AD)
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E.2.2 | Secondary objectives of the trial |
-Additional characterization of safety of long-term treatment with amlitelimab in participants with AD
-Characterize the efficacy of long-term treatment with amlitelimab in participants with AD
-Characterize the pharmacokinetics profile of amlitelimab
-Characterize the pharmacodynamic profile of amlitelimab
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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 |
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E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply:
- 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 long-term 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 protocol-defined 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 non-interventional 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 µmol/L),
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of participants who experienced treatment-emergent adverse event (TEAE) from baseline during the study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1)Percentage of participants who experienced treatment-emergent SAEs from baseline during the study
2)Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) from baseline during study
3)Absolute change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
4)Percent change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
5)Proportion of participants with EASI75/EASI90/EASI100 from KY1005-CT05 (DRI17366) baseline at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
6)Proportion of participants with a response of investigator global assessment (IGA) 0 or 1and a reduction from baseline of ≥2 points at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
7)Absolute change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
8)Percent change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
9)Proportion of participants with EASI50/EASI75/EASI90/EASI100 at pre-specified timepoints in all participants entering the study
10)Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTE entry in all participants entering the study
11)Time to first remission after LTE enrolment (achieving IGA 0/1) in those participants who had not achieved IGA 0/1 by the time of LTE entry in all participants entering the study
12)Proportion of participants with IGA score 0/1 at each visit in all participants entering the study
13)Proportion of participants with low disease activity state (e.g., IGA ≤2) at each visit in all participants entering the study
14)Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study
15)Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study
16)Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study
17)Number of days on topical medication (per patient-year) in all participants entering the study
18)Change from LTE baseline to prespecified timepoints through the end of the study: atopic dermatitis control tool (ADCT) in all participants entering the study
19)Change from LTE baseline to prespecified timepoints through the end of the study: dermatology life quality index (DLQI) in all participants entering the study
20)Change from LTE baseline to prespecified time points through the end of the study: patient oriented eczema measure (POEM) in all participants entering the study
21)Serum amlitelimab concentration assessed at prespecified time points through the end of the study
22)Anti-amlitelimab antibody titre in participants with positive response
23)Number of participants with positive anti-drug antibody response |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1)Baseline to Week 120
2)Baseline to Week 120
3)DRI17366 Baseline to Week 104
4)DRI17366 Baseline to Week 104
5)DRI17366 Baseline to Week 104
6)Baseline to Week 104
7)Baseline to Week 104
8)Baseline to Week 104
9)Baseline to Week 104
10)Baseline to Week 104
11)Baseline to Week 104
12)Baseline to Week 104
13)Baseline to Week 104
14)Baseline to Week 120
15)Baseline to Week 120
16)Baseline to Week 120
17)Baseline to Week 120
18)Baseline to Week 104
19)Baseline to Week 104
20)Baseline to Week 104
21)Baseline to Week 104
22)Baseline to Week 120
23)Baseline to Week 120 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Japan |
Taiwan |
United States |
Poland |
Bulgaria |
Spain |
Czechia |
Germany |
Hungary |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 30 |