CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
IGE025 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Diagnosis of chronic spontaneous urticaria that has not responded to H1 antihistamines
Key exclusion· 4
  • ✕Clearly defined underlying cause for chronic urticaria other than CIU (e.g., acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact urticaria)
  • ✕Associated diseases with urticaria or angioedema symptoms: urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
  • ✕Previous treatment with omalizumab
  • ✕History or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01599637
NCT01599637Phase 2Completed
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted May 16, 2012·Updated Mar 31, 2015

In Brief

A Phase 2 clinical trial evaluating IGE025 and placebo for Chronic Idiopathic Urticaria. Completed, enrolled 40 participants across 4 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Urticaria
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2012
Enrollment StartApr 1, 2012
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.1 years ago

Interventions

IGE025drug

Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.

placebodrug

Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.