moderate to severe chronic spontaneous urticaria with angioedema MedDRA version: 14.1 Level: LLT Classification code 10009159 Term: Chronic urticaria System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Xolair
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Current Sponsor code: IGE025
Concentration unit: mg millig
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is informed about study procedures and medications and has given written informed consent before any assessment. 2. Patient is able to communicate with the investigator, understands and complies with the requirements of the study. 3. Male or Female of any race aged 18-75 years 4. Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at Baseline (Day -14) based on patient’s medical history, as defined by all of the following: • The presence of itch and hives for > 6 weeks • UAS7 score (range 0-42) = 14 5. Patient has a history of insufficient response to 4x of the approved dose of nsH1-antihistamines. 6. Patients on high dose nsH1-antihistamine (2-4x of the approved dose) for at least 3 consecutive days immediately prior to the Day -14 screening visit (current use must be documented on the day of screening visit). 7. CU-Q2oL Score = 30 at baseline 8. CSU diagnosis for = 6 months 9. CSU with occurrence of angioedema at least 4x in the last 6 months 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with non urticaria associated angioedema 2. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of the compound, whichever is longer 3. History of hypersensitivity to any of the study drugs (omalizumab) or rescue medication or to drugs of similar chemical structures. 4. Evidence of parasitic infection. 5. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch. 6. Previous treatment with omalizumab within 6 months prior to screening. 7. Treatment with defined comedications 8. History of anaphylactic shock. 9. Presence of clinically significant cardiovascular, bronchial, neurological, psychiatric, metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients. 10. Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions. 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 12. Women who are pregnant or breast feeding or capable of becoming pregnant and not practicing a medically approved method of contraception1. 15. Permanent severe diseases, especially those affecting the immune system, except CSU. 16. Presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract). 17. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia. 18. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. 19. Evidence of severe renal dysfunction. 20. Evidence of significant hepatic disease. 21. Patient considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits. 22. Serious psychiatric and/or psychological disturbances. 23. History of drug or alcohol abuse. 24. Patient unable to complete a patient diary or complete questionnaires on paper. 25. Any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule. 12.26. Patients, who have already been randomized into this trial earlier must not be included a second time. 13.27. Study personnel or first degree relatives of investigator(s) must not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the superiority of omalizumab 300 mg versus placebo in patients with moderate to severe CSU regarding QoL measures. This will be done by evaluating the change of total CU-Q2oL scores in moderate to severe CSU patients with a history of angioedema and insufficient treatment response to a high dose of nsH1-antihistamines (second line treatment: up to 4x of the approved nsH1-Antihistamine dose). Scores will be calculated from baseline (visit 2) to week 28 (visit 9) with secondary objective(s).;Secondary Objective: ? Angioedema burdened days ? Angioedema Activity Score (AAS) ? AE-Q2oL (Angioedema Quality-of-Life Score) ? Time to first angioedema episode following initiation of study therapy ? Time interval between successive angioedema episodes following initiation of therapy ? Time to first recurrence after discontinuation of omalizumab /placebo therapy within follow-up period ? Need for sedating H1-antihistamine and corticosteroids based rescue medication (as specified under 6.6.4) ? UAS7 (weekly Urticaria Activity Score) ? DLQI (Dermatology Quality of Life Index) ;Primary end point(s): The primary variable is the change from baseline to week 28 of the CU-Q2oL questionnaire. ;Timepoint(s) of evaluation of this end point: week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The AAS, AE-Q2oL, UAS7 and DLQI will be analyzed analogous to the primary endpoint, as a mean difference from baseline (visit 2) to week 28 (visit 9). Time courses will be displayed descriptively and graphically. For these analyses, values of patients requiring rescue medication will not be used for 6 weeks (resp. 4 weeks for the DLQI) following the last corticosteroid intake. Other secondary or exploratory objectives (e.g. rescue medication use, angioedema burdened days) will be summarized descriptively by treatment group. ;Timepoint(s) of evaluation of this end point: week 28 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed