COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01987947
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Urticaria Drug: Placebo Drug: Quilizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Two administrations by subcutaneous injection

Active Comparator: Quilizumab Drug: Quilizumab
Two administrations by subcutaneous injection

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01987947

Layout table for location information
Canada, Ontario
Toronto, Ontario, Canada, M4V 1R2
Berlin, Germany, 10117
Mainz, Germany, 55131
Sponsors and Collaborators
Genentech, Inc.
Layout table for investigator information
Study Director: Clinical Trials Genentech, Inc.
Layout table for additonal information
Responsible Party: Genentech, Inc. Identifier: NCT01987947    
Other Study ID Numbers: GX29107
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Keywords provided by Genentech, Inc.:
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases