E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Spontaneous Urticaria |
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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] - 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 | 10072757 |
E.1.2 | Term | Chronic spontaneous urticaria |
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 |
To evaluate the efficacy of ligelizumab assessed as the proportion of subjects achieving UAS7≤6 after 12 weeks of retreatment, in subjects previously treated in the core studies CQGE031C2302/ CQGE031C2303 as well as in the subset of subjects who previously achieved UAS7<6 in the core studies. |
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E.2.2 | Secondary objectives of the trial |
To describe the efficacy of ligelizumab assessed as the proportion of subjects achieving UAS7=0 after 12 weeks of retreatment, in subjects previously treated in the core studies
• To describe the efficacy of ligelizumab assessed as the reduction from extension study baseline in the UAS7 and its components
• To describe the efficacy of ligelizumab in achieving an angioedema-free period at Week 12 previously treated in the core studies
• To describe the efficacy of ligelizumab in achieving Dermatology Life Quality Index = 0-1 at Week 12 previously treated in the core studies
• To describe the efficacy of ligelizumab in the treatment of CSU (UAS7<6), 12 weeks after starting self-administration.
• To assess the safety and tolerability of ligelizumab in all subjects
• To assess the safety and tolerability of ligelizumab pre-filled syringe (PFS)
• To assess the safety and tolerability of ligelizumab in all subjects who self-administer |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent
2. Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
3. Male and female, adult and adolescent subjects ≥12 years of age
4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule |
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E.4 | Principal exclusion criteria |
1. Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
2. Use of omalizumab within 16 weeks of Visit 101 or 201 (whichever
occurs first).
3. History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
4. New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
5. Diseases with possible symptoms of urticaria or angioedema
6. Subjects with evidence of helminthic parasitic infection
7. Documented history of anaphylaxis
8. Pregnant or nursing (lactating) women |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects with well-controlled disease (UAS7 ≤ 6) at Week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• The proportion of subjects with completely controlled disease (UAS7 =0) at Week 12
• Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12
• Cumulative number of weeks that subjects achieve angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
• Percentage of subjects achieving DLQI = 0-1 at Week 12
• The proportion of subjects with well-controlled disease (UAS7 ≤ 6), 12 weeks after starting self-administration
In each dose group, and for each duration of treatment:
• Occurrence of treatment emergent adverse events during the study
• Occurrence of treatment emergent serious adverse events during the study
• Vital signs
• Lab assessments
For the duration of treatment:
• Occurrence of treatment emergent serious adverse events during study Week 12 onwards
• Vital signs Week 12 onwards
• Lab assessments Week 12 onwards
• Occurrence of treatment emergent adverse events
• Occurrence of treatment emergent serious adverse events
• Vital signs
• Lab assessments |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the study; including Week 12 and each protocol defined study visit |
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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 | Yes |
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) | 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 | 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 | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 102 |
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 |
Australia |
Brazil |
Canada |
Chile |
Colombia |
Egypt |
Guatemala |
India |
Israel |
Japan |
Korea, Republic of |
Lebanon |
Malaysia |
Mexico |
Morocco |
Oman |
Peru |
Philippines |
Russian Federation |
Singapore |
South Africa |
Taiwan |
Thailand |
Tunisia |
Turkey |
United States |
Vietnam |
Austria |
Belgium |
Bulgaria |
Croatia |
Denmark |
Estonia |
Finland |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Romania |
Slovakia |
Spain |
Sweden |
United Kingdom |
Czechia |
Argentina |
Greece |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 6 |