A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study Of Xolair (Omaluzimab) In Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Anithistamine Treatment (H1)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-009498-87-DE
• Date of registration: 20/03/2009
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study Of Xolair (Omaluzimab) In Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Anithistamine Treatment (H1)
• Scientific title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study Of Xolair (Omaluzimab) In Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Anithistamine Treatment (H1)
• Date of first enrolment: 25/06/2009
• Target sample size: 76
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009498-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1) Signed Informed Consent Form
2) Aged 12-75 years (in Germany, 18-75 years)
3) Diagnosis of moderate to severe CIU at the time of screening, as defined by pruritus and hives for > 3 days in a 7-day period for > 6 consecutive weeks despite treatment with H1 antihistamine
4) CIU diagnosis > 3 months (by history)
5) The non-diary based UAS score >= 4 established in the clinic at the time of screening visit (Week -2) and at run-in visit (Week -1)
6) A diary-based UAS7 score = 12 (equivalent of moderate to severe CIU) at the time of randomization (Week 0) despite stable doses of H1 antihistamine
7) No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
8) Compliance with study procedures during run-in period (e.g., completion of the study diary)

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:
1) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin test. Women of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. “Medically approved” contraception may include implants, injectables, combined oral contraceptives, intrauterine devices, and also abstinence, at the discretion of the investigator.
2) Patients < 40kg
3) Treatment with any investigational agent within 30 days of screening
4) Recent history of drug or alcohol abuse (within 3 years prior to Visit 1)
5) Atopic dermatitis or other skin disease associated with pruritus
6) Clinically relevant major systemic disease (making interpretation of the study results difficult)
7) Inability to comply with study and follow-up procedures
8) Previously treated with omalizumab (< 12 months since last injection)
9) Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, sulfasalazine, dapsone, methotrexate, cyclosporine, cyclophosphamide, IVIG, plasmapheresis, or other monoclonal antibody therapies
10)Patients may not have been taking cyclosporine within the past month prior to screening
11) Patients may not take doxepin during screening, run-in or treatment period or have been taking doxepin within the past 6 weeks regular (daily/every other day) prior to screening
12) Patients may not take systemic corticosteroids or cutaneous corticosteroid (intranasal, inhaled, and ophtahalmic steroids are permitted) during the screening, run-in, or treatment periods
13) Patients may not take H2 antihistamines and leukotriene receptor antagonists within 7 days before screening, during the screening, run in, or treatment phases
14) Contraindications to diphenhydramine: Overreactivity against the agent dyphenhydramine, other antihistaminic agents, or other components of this agent; acute bronchial asthma; acute angle-closure glaucoma; pheochromocytoma; hyperplasia of the prostate gland with formation of residual urine; epilepsy; hypokalemia; hypomagnesemia; bradycardia; a congenital long QT syndrome or other clinically significant cardial disorders (especially coronary heart disease, disturbances in conduction, arrhythmias); the simultaneous application of drugs which prolong the QT interval (e.g., antiarrhythmic drugs class IA or III, antibiotics, cisapride, malaria drugs, antihistaminic drugs, neuroleptic drugs) or lead to hypokalemia (e.g., certain diuretic drugs); the simultaneous application of MAO inhibitors; the simultaneous uptake of alcohol.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Idiopathic Urticaria
MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria
MedDRA version: 9.1 Level: LLT Classification code 10021247 Term: Idiopathic urticaria

Intervention(s)

Trade Name: Xolair
Product Name: Xolair
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Omalizumab
CAS Number: 242138-07-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Xolair
Product Name: Xolair
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Omalizumab
CAS Number: 242138-07-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Xolair
Product Name: Xolair
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Omalizumab
CAS Number: 242138-07-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To evaluate the safety and efficacy of different dose levels of omalizumab in patients with refractory CIU
To evaluate the efficacy of omalizumab in patients with refractory CIU on the patient reported quality of life?related outcome measures
To evaluate the pharmacokinetics and pharmacodynamics of omalizumab in patients with refractory CIU

Main Objective: To evaluate the efficacy of single doses of omalizumab compared with placebo in patients with refractory chronic idiopathic urticaria (CIU) receiving concomitant H1 antihistamine therapy

Primary end point(s): The primary efficacy endpoint is change in diary-based UAS7 from baseline to 4th week (Days 21-27) in the treatment period. The UAS score, which is the sum of pruritus score and score for number of hives, will be used to calculate the UAS7 score. The UAS7 score is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days. The UAS7 score 1 week prior to randomization will be used as the baseline.

Secondary ID(s)

Q4577g