Recent Updates
Recently added Catalysts

IGE025

Phase 2

Chronic Idiopathic Urticaria | Small molecule | Dermatology |Novartis AG|Last Updated: Mar 31, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01599637Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine TreatmentPHASE2 COMPLETED 40 — — Apr 1, 2012Sep 1, 2013Mar 31, 20154 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Baseline through Day 85 post-treatment

Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Baseline through Day 85 post-treatment

Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Secondary Endpoints
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
Baseline through Day 85
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
Baseline through Day 85
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
Baseline to Day 85
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
IGE025EXPERIMENTALPatients will receive omalizumab administered subcutaneously every 4 weeks at the study center.
Placebo to IGE025PLACEBO_COMPARATORPlacebo administered subcutaneously every 4 weeks at the study center.
Interventions
NameTypeDescription
IGE025DRUGStudy medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
placeboDRUGStudy medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

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...

Countries:Germany
Unlock Eligibility Criteria