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

NCT01987947 | Completed Phase 2

• 1 other identifier: GX29107
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 3

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.

Conditions

Urticaria

Keywords

MEMP1972A

Outcome Measures

Primary Outcomes (3)

• Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.

  21 weeks

• Safety: Incidence & severity of adverse events.

  Approximately 30 weeks

• Safety: Incidence of anti-therapeutic antibodies.

  Approximately 30 weeks

Secondary Outcomes (2)

• Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.

  5 weeks

• Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.

  21 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Quilizumab

ACTIVE COMPARATOR

Drug: Quilizumab

Interventions

Placebo DRUG

Two administrations by subcutaneous injection

Placebo

Quilizumab DRUG

Two administrations by subcutaneous injection

Quilizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Unknown Facility

Toronto, Ontario, M4V 1R2, Canada

Location

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

DE (2); CA (1)