E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe Eosinophilic Asthma |
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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] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068462 |
E.1.2 | Term | Eosinophilic asthma |
E.1.2 | System Organ Class | 100000004855 |
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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 |
• Safety of ANB020 in adult patients with severe eosinophilic asthma: Number of participants with treatment-related adverse events as
assessed by CTCAE v. 4.0
• Change in blood eosinophil count |
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E.2.2 | Secondary objectives of the trial |
• Change in respiratory function
• Describe Limited Pharmacokinetics
• Test for immunogenicity
• Describe Limited Pharmacodynamics |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female patients aged ≥18 to ≤65 years and able to give informed consent.
• Patients with a confirmed clinical diagnosis of eosinophilic asthma
• History of diagnosis of eosinophilic asthma
• Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016
• Body mass index (BMI) of 18 to 38 kg/m2 (inclusive) and total body weight >50 kg (110 lb.).
• Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use effective methods of
contraception throughout the study.
• Male patients must be willing to use effective methods of contraception during the entire study period.
• Patient must be on high dose ICS plus LABA.
• Willing and able to comply with the study protocol requirements.
• Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff.
For additional details refer to the study protocol. |
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E.4 | Principal exclusion criteria |
• Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the patient's response to the IP.
• Have experienced severe life threatening anaphylactic reactions.
• Have received any IP within a period of 3 months or 5 half lives of an IP
• Have received high dose systemic corticosteroids
• Have received treatment with biologics within 3 months or 5 half lives (whichever is longer) before screening.
• Abnormal ECG assessment at screening
• Uncontrolled hypertension, or acute ischemic cardiovascular diseases.
• If female, is pregnant or lactating, or intend to become pregnant during the study period.
• History (or suspected history) of alcohol or substance abuse within 2 years before screening.
• Any comorbidity that the Investigator believes is a contraindication to study participation.
• Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.
• Planned surgery during the study or 30 days before screening.
• History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease.
For additional details refer to the study protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Number of participants with treatment-related adverse events as assessed by CTCAE v. 4.0
• Monitor peripheral blood eosinophil counts |
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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) |
• Monitor FEV1 variation
• Maximum observed concentration (Cmax) and time to Cmax
• Detection of ADA
• Pharmacodynamic analysis |
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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 | 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 | Yes |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |