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

Urticaria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987947
• Other study ID #: GX29107
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2013
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• Placebo
Two administrations by subcutaneous injection
• Quilizumab
Two administrations by subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.		21 weeks	No
Primary	Safety: Incidence & severity of adverse events.		Approximately 30 weeks	No
Primary	Safety: Incidence of anti-therapeutic antibodies.		Approximately 30 weeks	No
Secondary	Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.		5 weeks	No
Secondary	Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.		21 weeks	No