CHRONIC IDIOPATHIC URTICARIA (CIU) MedDRA version: 12.1 Level: LLT Classification code 10021247 Term: Idiopathic urticaria
Conditions
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: 1. Aged 12-75 years (age limits may vary dependent upon regional restrictions). 2. Diagnosis of CIU refractory to H1 antihistamines at the time of randomization, as defined by all of the following: The presence of itch and hives for = 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment during this time period UAS7 score (range 0-42) = 16 and itch component of UAS7 (range 0-21) = 8 during 7 days prior to randomization (Week 0) 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 an approved dose of an H1 antihistamine for CIU for at least the 3 consecutive days immediately prior to the Day -14 screening visit and must document current use on the day of the initial screening visit. CIU diagnosis for = 6 months. 3. Willing to give written informed consent, adhere to the visit schedules and meet study requirements.For those patients below the legal age of consent, the child must be willingto give written informed assent and the parent(s)/guardian(s) must be willing to give written informed consent. For patients below the legal age of consent, both child and parent must be able to adhere to dose and visit schedules and meet study requirements. 4. Willing and able to complete a daily symptom eDiary for the duration of the study. 5. Patients must not have any missing eDiary entries in the 7 days prior to randomization. Are the trial subjects under 18? yes 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: Patients who meet any of the following criteria will be excluded from study entry: 1. Treatment with an investigational agent within 30 days of Day -14. 2. Weight less than 20 kg (44 lbs). 3. Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact As well as the following diseases as these diseases may have symptoms of urticaria or angioedema Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer. 4. Evidence of parasitic infection defined as having the following three items: Risk factors for parasitic disease (living in an endemic area, chronic GI symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression) AND An absolute eosinophil count more than twice the upper limit of normal AND Evidence of parasitic colonization or infection on stool evaluation for ova and parasites. Note that stool ova and parasite evaluation will only be conducted in patients with both risk factors and an eosinophil count more than twice the upper limit of normal. 5. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch. 6. Previous treatment with omalizumab within a year prior to Day -14. 7. Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -14: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. 8. IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day -14. 9. Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -14. 10. Any H2 antihistamine use within 7 days prior to Day -14. 11. Any LTRA (montelukast or zafirlukast) within 7 days prior to Day -14. 12. Any H1 antihistamines at greater than approved doses within 3 days prior to Day -14. 13. Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved. 14 .Hypersensitivity to omalizumab or any component of the formulation. 15. History of anaphylactic shock. 16. Presence of clinically significant cardiovascular, 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. 17. Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study. Any items that are cause for uncertainty must be reviewed with the Medical Monitor. 18. Inability to comply with study and follow-up procedures. 19. Evidence of current drug or alcohol abuse. 20. Nursing women or women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective •To evaluate the efficacy of omalizumab compared with placebo in patients with refractory chronic idiopathic urticaria (CIU) receiving concomitant H1 antihistamine therapy ;Secondary Objective: Secondary Objectives • To evaluate the safety of omalizumab therapy in patients with refractory CIU • To evaluate onset of clinical effect of omalizumab therapy in CIU • To evaluate the dose of omalizumab therapy in patients with refractory CIU • To evaluate duration of response after withdrawal of omalizumab in patients with refractory CIU • To evaluate the quality-of-life benefit of omalizumab therapy in patients with refractory CIU;Primary end point(s): The primary efficacy endpoint is the change in weekly itch score from baseline to Week 12. The analysis of the primary endpoint will consist of treatment comparisons made using analysis of covariance (ANCOVA) controlling for baseline weekly itch score, and baseline weight (less than 80 kg vs. more than or equal to 80 kg). The ANCOVA model will be based on the mITT patients. Missing Week 12 itch scores will be imputed by carrying forward the patients’ baseline scores (BOCF). The Week 12 itch scores for patients who received excluded therapy listed in Section 4.4.2 by Week 12 will also be imputed using their baseline scores. | — |
Countries
Denmark, France, Germany, Italy, Spain
Outcome results
None listed