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

NCT ID: NCT01987947

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-10-31

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.

Conditions

Urticaria

Keywords

MEMP1972A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Two administrations by subcutaneous injection

Quilizumab

Group Type: ACTIVE_COMPARATOR

Quilizumab

Intervention Type: DRUG

Two administrations by subcutaneous injection

Interventions

Placebo

Two administrations by subcutaneous injection

Intervention Type: DRUG

Quilizumab

Two administrations by subcutaneous injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Toronto, Ontario, Canada

Berlin, , Germany

Mainz, , Germany

Countries

Canada; Germany

Other Identifiers

GX29107

Identifier Type: -

Identifier Source: org_study_id