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 |
|
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 | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal 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 |
Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.
Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study, with regards to:
- Systemic exposure
- Anti-drug antibodies
- Biomarkers
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible patients who have completed the entire study duration of DRI12544, or who completed the treatment period in the other previous asthma studies. |
|
E.4 | Principal exclusion criteria |
Patients who didn’t complete the DRI12544 study or the treatment period in other previous asthma studies.
Patients who have experienced hypersensitivity reactions to dupilumab which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratory assessments before enrollment have ruled out an active infection.
Medical history of human immunodeficiency virus (HIV) infection.
Known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment.
Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before Visit 1; significant viral infections within 4 weeks before Visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment).
Patients with any event or laboratory abnormality that, as per Investigator judgment, would adversely affect participation of the patient in this study.
Patients who have traveled to parasitic endemic area within 6 months prior to screening.
For patients from DRI12544 study, drug induced liver injury related criteria at Screening:
- Underlying clinically significant hepatobiliary disease OR
- Alanine Aminotransferase (ALT) >3 Upper Limit of Normal (ULN).
For patients from DRI12544 study, abnormal lab values at Screening:
- Creatine phosphokinase (CPK) >10 ULN OR
- Platelets <100.000 cells/mm^3 OR
- Eosinophils >1500 cells/mm^3
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants with adverse events |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Assessment of safety parameters (laboratory data, electrocardiogram and vital signs) - clinically significant changes from baseline
2) Forced expiratory volume in one second - clinically significant changes from baseline
3) Asthma control questionnaire - clinically significant changes from baseline
4) Asthma symptom scores - clinically significant changes from baseline
5) Asthma Quality of Life Questionnaire (AQLQS) - clinically significant changes from baseline
6) Anti-drug antibodies - changes from baseline
7) Biomarkers - changes from baseline |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) to 6) : Week 112
7) : Week 96 |
|
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 146 |
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 |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
Chile |
Colombia |
France |
Germany |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Poland |
Romania |
Russian Federation |
South Africa |
Spain |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 13 |