Clinical trial NCT01599637: Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
Official title: A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Determine the Mode of Action of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Idiopathic Urticaria
Keywords: Chronic idiopathic urticaria
CIU
Xolair
IGE025
FcεRI
IgE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline

Exclusion Criteria:

* Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact, as well as the following diseases as these diseases may have symptoms of urticaria or angioedema: Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer.
* Previous treatment with omalizumab.
* A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
timeFrame: Baseline through Day 85 post-treatment
measure: Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
timeFrame: Baseline through Day 85 post-treatment
Secondary outcomes:
measure: Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
timeFrame: Baseline through Day 85
measure: Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
timeFrame: Baseline through Day 85
measure: Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit
timeFrame: Baseline to Day 85
measure: Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit
timeFrame: Baseline through Day 85
measure: Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.
timeFrame: Baseline through Day 85
measure: Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.
timeFrame: Baseline through Day 85
measure: Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set
timeFrame: Baseline
measure: Serum Levels of Omalizumab
timeFrame: Baseline through Day 85
measure: Mean (SD) Serum Total IgE Concentration From Baseline by Visit
timeFrame: Baseline through Day 85
measure: Mean (SD) Serum Total IgE % Change From Baseline by Visit
timeFrame: Baseline through Day 85
measure: Mean (SD) Serum Free IgE Concentration From Baseline by Visit
timeFrame: Baseline through Day 85
measure: Mean (SD) Serum Free IgE % Change From Baseline by Visit
timeFrame: Baseline through Day 85
measure: Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit
timeFrame: Baseline through Day 140
measure: Change From Baseline in Urticaria Activity Score (UAS7)
timeFrame: Baseline, Day 85
measure: Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment
timeFrame: Baseline, Day 85
measure: Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment
timeFrame: Day 29 to Day 85
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment
timeFrame: Baseline through Day 85
measure: Skindex-29 by Treatment
timeFrame: Baseline and Day 85
measure: Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment
timeFrame: Baseline and Day 85
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Metz M, Torene R, Kaiser S, Beste MT, Staubach P, Bauer A, Brehler R, Gericke J, Letzkus M, Hartmann N, Erpenbeck VJ, Maurer M. Omalizumab normalizes the gene expression signature of lesional skin in patients with chronic spontaneous urticaria: A randomized, double-blind, placebo-controlled study. Allergy. 2019 Jan;74(1):141-151. doi: 10.1111/all.13547. Epub 2018 Oct 15.