Phase 2 N=40 Randomized Double-blind Basic Science

Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment

Chronic Idiopathic Urticaria

Bottom Line

View on ClinicalTrials.gov: NCT01599637 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Nov 2014

Primary outcome: Primary: Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin — 18.14; 15.17; 13.40; 20.19 FcεRI positive skin cells

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IGE025 (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin	18.14; 15.17; 13.40; 20.19; -5.42; 3.69	—
PRIMARY Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin	12.93; 15.23; 6.73; 12.47; -5.69; -3.95	—
SECONDARY 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	0.3305; -0.1889; 0.2785; 0.5057; 0.0021; 0.0101	—
SECONDARY 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	0.4841; -0.0952; 0.2759; 0.4947; 0.2190; -0.1142	—
SECONDARY 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	1.06; 1.25; 1.41; 0.95; 0.39; -0.30	—
SECONDARY Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit	2.9669; 3.0394; 2.8190; 3.3035; 2.5597; 2.2742	—
SECONDARY 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.	0.23; 0.36; 0.47; 0.40; 0.22; -0.06	—
SECONDARY 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.	292391; 312038; 79457; 291000; -243700; -38260	—
SECONDARY Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set	1.1600; 1.1241; 14.6400; 19.6207; 7.9000; 10.3724	—
SECONDARY Serum Levels of Omalizumab	0.0; 13400; 30100; 17000; 25000; 28800	—
SECONDARY Mean (SD) Serum Total IgE Concentration From Baseline by Visit	1037; 442; 1152; 447; 1970; 449	—
SECONDARY Mean (SD) Serum Total IgE % Change From Baseline by Visit	27.1; 0.2; 174.7; -1.5; 247.2; -4.0	—
SECONDARY Mean (SD) Serum Free IgE Concentration From Baseline by Visit	1037; 442; 26.8; 111.5; 24.306; 112.169	—
SECONDARY Mean (SD) Serum Free IgE % Change From Baseline by Visit	-96.166; -60.475; -96.446; -60.804; -93.363; -61.456	—
SECONDARY Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit	NA; 0.1360; NA; 0.1140; 0.2730; 1.4800	—
SECONDARY Change From Baseline in Urticaria Activity Score (UAS7)	-23.1; -8.1	—
SECONDARY Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment	2.0; 2.2; 0.8; 2.0; 2.4; 2.4	—
SECONDARY Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment	90.9; 70.5	—
SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment	-10.19; -3.13	—
SECONDARY Skindex-29 by Treatment	17.98; 21.67; 6.17; 22.63	—
SECONDARY Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment	53.71; 59.24; 14.51; 53.53	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01599637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.