A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria

Study Overview
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Brief Summary
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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.

Conditions
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Urticaria

Intervention / Treatment
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* Drug: Placebo
* Drug: Quilizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Two administrations by subcutaneous injection<br>|
| Active Comparator: Quilizumab<br> | Drug: Quilizumab<br>* Two administrations by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MEMP1972A