Back to resultsA Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
Primary Purpose
Urticaria
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Quilizumab
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria focused on measuring MEMP1972A
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Quilizumab
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
Safety: Incidence & severity of adverse events.
Safety: Incidence of anti-therapeutic antibodies.
Secondary Outcome Measures
Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.
Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01987947
Brief Title
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria
Keywords
MEMP1972A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Quilizumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two administrations by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Quilizumab
Intervention Description
Two administrations by subcutaneous injection
Primary Outcome Measure Information:
Title
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
Time Frame
21 weeks
Title
Safety: Incidence & severity of adverse events.
Time Frame
Approximately 30 weeks
Title
Safety: Incidence of anti-therapeutic antibodies.
Time Frame
Approximately 30 weeks
Secondary Outcome Measure Information:
Title
Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.
Time Frame
5 weeks
Title
Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.
Time Frame
21 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
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