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

Genentech

Status and phase

Completed

Phase 2

Conditions

Urticaria

Treatments

Drug: Placebo

Drug: Quilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01987947

GX29107

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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