E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic dermatitis / Eczema |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD). |
|
E.2.2 | Secondary objectives of the trial |
No secondary objectives have been identified for the study |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Optional skin punch biopsy samples:
Skin punch biopsy samples will be used to study IL-4Rα, effect of IL-4Rα inhibition with a monoclonal antibody, immunology, inflammation, eosinophil-driven disease, and atopic diseases in the skin. Part of each sample from each time point will be processed for RNA extraction. RNA samples may be used for exploratory microarray expression profiling or transcriptome sequencing. The other samples will be fixed for histology or immunohistochemistry.
Optional genomics sub-study:
The purpose of the genomic analyses is to identify genomic associations with clinical or biomarker response to IL4-Rα inhibition, immunology, inflammation, eosinophil driven diseases, and atopic diseases. |
|
E.3 | Principal inclusion criteria |
1. Male and female patients aged 18 years or older
2. Chronic Atopic Dermatitis for at least 2 years
3. Patients must be applying an additive-free, basic bland emollient twice daily for at least 7 days before the baseline visit
|
|
E.4 | Principal exclusion criteria |
1. Prior treatment with REGN668
2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
3. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
4. Known history of human immunodeficiency virus (HIV) infection
5. History of clinical parasite infection
6. Pregnant or breast-feeding women
7. History of alcohol or drug abuse within 2 years of the screening visit
8. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known (whichever is longer), before the baseline visit
9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence and severity of adverse events (AEs). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the duration of the study |
|
E.5.2 | Secondary end point(s) |
No secondary end points have been identified for the study |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
No secondary end points have been identified for the study |
|
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 | Yes |
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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |