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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01987947
First received: November 13, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This multicenter, randomized, double-blind, placebo-controlled, parallel-group s tudy will assess the efficacy and safety of additional quilizumab therapy in adu lt patients with Chronic Spontaneous Urticaria resistant to antihistamine treatm ent.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Efficacy: Absolute change from baseline to Week 20 in the weekly itch score. [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence & severity of adverse events. [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of anti-therapeutic antibodies. [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Absolute change from baseline to Week 4 in the weekly itch score. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score. [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987947

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01987947     History of Changes
Other Study ID Numbers: GX29107
Study First Received: November 13, 2013
Last Updated: July 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Genentech:
MEMP1972A

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014