Patients with chronic spontaneous urticaria MedDRA version: 16.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: quilizumab
Product Code: MEMP1972A (RO5541079)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: quilizumab
Current Sponsor code: MEMP1972A (RO5541079)
Other descriptive n
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a history of chronic spontaneous urticaria for at least 6 months prior to study screening - Patients willing and able to fill out a symptom diary Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Patients with unstable medical conditions that are likely to change during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy and safety of quilizumab in patients with chronic spontaneous urticaria;Secondary Objective: To evaluate the pharmacokinetics and the pharmacodynamics of quilizumab in patients with chronic spontaneous urticaria;Primary end point(s): Improvement in itch score;Timepoint(s) of evaluation of this end point: at week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement in urticaria activity score;Timepoint(s) of evaluation of this end point: at week 20 | — |
Countries
Canada, Germany
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed