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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: November 13, 2013
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Urticaria Drug: Placebo Drug: Quilizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

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

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

Enrollment: 32
Study Start Date: December 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Two administrations by subcutaneous injection
Active Comparator: Quilizumab Drug: Quilizumab
Two administrations by subcutaneous injection


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01987947

Canada, Ontario
Toronto, Ontario, Canada, M4V 1R2
Berlin, Germany, 10117
Mainz, Germany, 55131
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01987947     History of Changes
Other Study ID Numbers: GX29107
Study First Received: November 13, 2013
Last Updated: November 1, 2016

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 18, 2017