Chronic Spontaneous Urticaria MedDRA version: 18.1 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: QGE031
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ligelizumab
Current Sponsor code: QGE031
Other descriptive name: anti-IgE antibody
Concentration unit: mg/ml milli
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female adult patients aged = 18 to = 75 years. -Diagnosis of CSU (with or without urticarial dermographism when testing for dermographism) refractory to H1-AH at approved or increased doses alone, or in combination with H2-AH and/or leukotriene receptor antagonist (LTRA) at the time of randomization, as defined by all of the following: - The presence of itch and hives for = 6 consecutive weeks at any time prior to enrollment despite current use of H1-AH (up to four times the approved dosage), or in combination with H2-AH and/or LTRA treatment during this time period - UAS7 score (range 0-42) = 16 and HSS7 (range 0-21) = 8 during 7 days prior to randomization (Day 1) - In-clinic UAS = 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1) - Patients must have been on H1-AH at approved or increased doses (up to fourfold) alone or in combination with H2-AH and/or a LTRA for treatment of CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit and must have documented current use on the day of the initial screening visit - CSU diagnosis for = 6 months -Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. - Patients must not have had any missing eDiary entries in the 7 days prior to randomization. Re-screening may be considered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lifes prior to Visit 1, whichever is longer. History of hypersensitivity to any of the study drugs or its components, or to drugs of similar chemical classes. Clearly defined underlying etiology for chronic urticarias other than CSU. This includes the following: Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g.,due to C1 inhibitor deficiency) Patients with a stool examination positive for ova or parasites (at screening); re-screening may be considered if a repeat stool examination is negative following treatment. Any other skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus etc.) Previous exposure to omalizumab or QGE031 History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to randomization Inability to comply with study and follow-up procedures Use of prohibited treatment detailed in protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the dose-response relationship of QGE031 with respect to achievement of complete hives response at Week 12 in patients with CSU when added to H1-AH alone or in combination with H2-AH and/or a LTRA;Primary end point(s): Achieving complete hives response at Week 12. Complete hives response is defined as a HSS7 score of 0. Analogously, complete itch response and complete UAS7 response are defined as an ISS7 and UAS7 score of 0, respectively.;Timepoint(s) of evaluation of this end point: at Week 12;Secondary Objective: Evaluate efficacy of QGE031 compared to omalizumab 300 mg with respect to achievement of complete hives response at Week 12 evaluate the efficacy of individual QGE031 doses of 24 mg, 72 mg and 240 mg s.c. compared to omalizumab 300 mg with respect to achievement of complete hives response at Week 20 Evaluate the efficacy of QGE031 doses of 24 mg, 72 mg and 240 mg s.c. versus placebo and omalizumab 300 mg: Change from Baseline in Hives Severity Score (HSS7) Change from Baseline in Itch Severity Score (ISS7) Change from Baseline in Urticaria Activity Score (UAS7) Evaluate the safety (including immunogenicity) and tolerability of QGE031 (doses of 24 mg, 72 mg and 240 mg s.c. every 4 weeks) versus placebo and omalizumab 300 mg | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the efficacy of QGE031 based on the selected dose response model compared to omalizumab 300 mg with respect to achievement of complete hives response. Evaluate the efficacy of individual QGE031 doses of 24 mg, 72 mg and 240 mg s.c. compared to omalizumab 300 mg with respect to achievement of complete hives response Evaluate the efficacy of QGE031 doses of 24 mg, 72 mg and 240 mg s.c. versus placebo and omalizumab 300 mg in patients with CSU, in terms of: Change from Baseline in Hives Severity Score (HSS7) Change from Baseline in Itch Severity Score (ISS7) Change from Baseline in Urticaria Activity Score (UAS7) evaluate the safety (including immunogenicity) and tolerability of QGE031 versus placebo and omalizumab 300 mg in patients with CSU particularly in regards to ECG adverse events vital signs and clinical laboratory;Timepoint(s) of evaluation of this end point: at Week 12 and Week 20 (as indicated in protocol) | — |
Countries
Australia, Canada, Germany, Greece, Japan, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinial Trial Information Desk
Novartis Pharma AG
Outcome results
None listed