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

November 1, 2016 updated by: Genentech, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4V 1R2
  • Germany
      • Berlin, Germany, 10117
      • Mainz, Germany, 55131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Two administrations by subcutaneous injection
Active Comparator: Quilizumab
Drug: Quilizumab
Two administrations by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
Time Frame: 21 weeks
21 weeks
Safety: Incidence & severity of adverse events.
Time Frame: Approximately 30 weeks
Approximately 30 weeks
Safety: Incidence of anti-therapeutic antibodies.
Time Frame: Approximately 30 weeks
Approximately 30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.
Time Frame: 5 weeks
5 weeks
Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.
Time Frame: 21 weeks
21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX29107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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