Urticaria
Conditions
Keywords
MEMP1972A
Brief summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.
Interventions
DRUGPlacebo
Two administrations by subcutaneous injection
DRUGQuilizumab
Two administrations by subcutaneous injection
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CSU refractory to H1 antihistamines with/without LTRAs, as defined by the following: * The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment despite use of H1 antihistamines during this time period * UAS7 score greater than 16 and itch component of UAS7 greater than 8 during 7 days prior to Day 1. Patients must have been on daily stable doses of H1 antihistamine for at least 3 consecutive days immediately prior to the screening visit and must document current use at screening * CSU diagnosed for more than 6 months * Patients must have a minimum diary compliance (6 out of 7 consecutive days) prior to Day 1
Exclusion criteria
* Treatment with an investigational agent within 30 days of screening, and previous treatment with monoclonal antibody therapies used to treat CSU 9 months prior to screening * Chronic urticarias other than CSU, including the following: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact. * Other diseases and conditions with symptoms of urticaria. * Routine doses of the following medications within 30 days prior to screening: systemic or topical corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide * IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening * Patients with cancer, history of cancer considered uncured or in complete remission for \< 10 years, or currently under work-up for suspected cancer except non-melanoma skin cancer that has been treated or excised and is considered resolved * History of anaphylactic shock without clearly identifiable avoidable antigen * Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions. * Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study. * Evidence of current drug or alcohol abuse * Nursing women and women of childbearing potential, unless using effective contraception as defined by protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Absolute change from baseline to Week 20 in the weekly itch score. | 21 weeks |
| Safety: Incidence & severity of adverse events. | Approximately 30 weeks |
| Safety: Incidence of anti-therapeutic antibodies. | Approximately 30 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Absolute change from baseline to Week 4 in the weekly itch score. | 5 weeks |
| Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score. | 21 weeks |
Countries
Canada, Germany
Outcome results
None listed