E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate-to-Severe Atopic Dermatitis |
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E.1.1.1 | Medical condition in easily understood language |
Moderate-to-Severe Atopic Dermatitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 |
The primary objective of this study is to evaluate the effects of ANB020 on skin lesions. |
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E.2.2 | Secondary objectives of the trial |
Secondary Objective: To evaluate the safety and tolerability of ANB020. To evaluate the effects of ANB020 on pruritus symptoms. To evaluate the effects of ANB020 on quality of life. Exploratory Objective: To evaluate the effects of ANB020 on asthma symptoms. To evaluate the immunogenicity of ANB020. To characterize the PK of ANB020. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
● Male or female subjects must be 18 to 75 years of age, at the time of signing the informed consent. ● Body mass index (BMI) of 18 to ≤35 kg/m2 for females and 18 to 40 kg/m2 for males, and total body weight >50 kg (110 lb). ● Clinically confirmed diagnosis of AD. ● Eczema Area and Severity Index (EASI) score ≥16, body surface area (BSA) involvement ≥10%, and an Investigator’s Global Assessment (IGA) score (5-point scale) ≥3 at Baseline. ● Subjects with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable. ● Daily use of non-medicated emollient for at least 7 days prior to Baseline. ● A WOCB who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after receiving the last dose of study treatment and refrain from donating oocytes (eggs)during this period.
For additional details refer to the study protocol |
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E.4 | Principal exclusion criteria |
● Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing. ● Prior exposure to an anti-IL-33 antibody. ● Exposure to an investigational or licensed or other anti-Th2-type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer. ● History of prior exposure to any investigational or biologic systemic treatment within 5 half-lives of the screening or is currently enrolled in another clinical study. ● Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening. ● History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is percent change in EASI score from Baseline to Week 16.
The safety and tolerability endpoints of this study are as follows: Incidence of AEs. Incidence of SAEs Incidence of Treatment Emergent Adverse Events (TEAEs) AEs leading to discontinuation of study drug AEs leading to withdrawal from the study AEs resulting in death Changes in vital signs (blood pressure [BP], temperature, respiration rate, heart rate [HR], and weight) Changes in clinical safety laboratory tests (hematology, chemistry, and urinalysis) Changes in ECG parameters Immunogenicity (anti-drug antibody [ADA] and neutralizing ADA) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the duration of the study. |
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E.5.2 | Secondary end point(s) |
Proportion of subjects with EASI-50 (≥50% improvement from Baseline) Proportion of subjects with EASI-75 (≥75% improvement from Baseline) Proportion of subjects with EASI-90 (>90% improvement from Baseline) Proportion of subjects who achieve vIGA-AD score reduction of ≥2 Proportion of subjects who achieve vIGA-AD response of 0 (clear) or 1 (almost clear) Proportion of subjects who achieve NRS for pruritus score reduction from Baseline of ≥4 Percent change in peak weekly averaged NRS for pruritus score from Baseline Percent change in SCORAD scores from Baseline Change from Baseline in DLQI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the duration of the study. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
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 |
Canada |
Czech Republic |
Germany |
Poland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |