Clinical trial NCT01987947: A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urticaria
Keywords: MEMP1972A
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
timeFrame: 21 weeks
measure: Safety: Incidence & severity of adverse events.
timeFrame: Approximately 30 weeks
measure: Safety: Incidence of anti-therapeutic antibodies.
timeFrame: Approximately 30 weeks
Secondary outcomes:
measure: Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.
timeFrame: 5 weeks
measure: Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.
timeFrame: 21 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
city: Berlin
country: Germany
city: Mainz
country: Germany
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: