E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic rhinosinusitis with nasal polyps |
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E.1.1.1 | Medical condition in easily understood language |
Chronic rhinosinusitis with nasal polyps is a condition in which painless growths called polyps are formed in the nasal passages and the sinuses along with inflammation and swelling |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
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 | 10028756 |
E.1.2 | Term | Nasal polyps |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal 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 |
•To evaluate adverse events associated with usage of omalizumab in patients with CRSwNP •To evaluate efficacy of continued treatment with omalizumab after an initial 24 week treatment period •To evaluate the durability of response following treatment discontinuation
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E.2.2 | Secondary objectives of the trial |
•To evaluate the impact of treatment duration with omalizumab on durability of response
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Ability to comply with the study protocol, in the investigator's judgment -Participation in Study GA39688 or Study GA39855, including completion of endoscopy and other assessments at Week 24 -Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior to the Week 24 visit of Study GA39688 or Study GA39855 -For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug
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E.4 | Principal exclusion criteria |
-Anaphylaxis/hypersensitivity related to study drug in Study GA39688/GA39855 -Serious adverse events related to study drug in Study GA39688/GA39855 that the investigator or Sponsor determines may jeopardize the patient's safety if he or she continues in the study -Uncontrolled epistaxis within Study GA39688 or GA39855 -Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab -Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence of serious and non-serious adverse events 2. Incidence of adverse events leading to omalizumab discontinuation 3. Change from baseline in NPS 4. Change from baseline in NCS
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2. Up to 76 weeks 3. At Weeks 4, 8, 16, 24 36, 52, 64, and 76 4. At Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
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E.5.2 | Secondary end point(s) |
1. Clinically significant change in laboratory values 2. Change from baseline In TNSS 3. Change from baseline In Loss of smell Week 76 4. Change from baseline In Posterior rhinorrhea 5. Change from baseline In Anterior rhinorrhea 6. Change from baseline In SNOT 22 7. Change from baseline In EQ-5D-5L 8. Change from baseline In AQLQ (patients with comorbid asthma only) 9. Change from baseline In UPSIT
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 76 weeks 2-5. At Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 6. At Weeks 4, 8, 16, 24, 36, 52, 64, and 76 7. At Weeks 16, 24, 36, 52, 64, and 76 8. At Weeks 4, 8, 16, 24, 36, 52, 64, and 76 9. At Weeks 8, 16, 24, 36, 52, 64, and 76
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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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Durability of response of omalizumab in an open-label setting |
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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) | No |
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 | No |
E.8.1.2 | Open | Yes |
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.8.2.4 | 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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
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 |
Belgium |
Canada |
Czech Republic |
Finland |
France |
Germany |
Hungary |
Mexico |
Poland |
Portugal |
Russian Federation |
Spain |
Ukraine |
United Kingdom |
United States |
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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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The end of the study is defined as the date of the last patient's last visit (LPLV). The LPLV is expected to occur approximately 52 weeks after the last patent is enrolled (28 week treatment period of OLE followed by 24-week follow-up period) |
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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 | 27 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 27 |