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

NCT ID: NCT01599637

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-09-30

Brief Summary

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

Conditions

Chronic Idiopathic Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

IGE025

Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center.

Group Type: EXPERIMENTAL

IGE025

Intervention Type: DRUG

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

Placebo to IGE025

Placebo administered subcutaneously every 4 weeks at the study center.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

IGE025

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Dresden, Germany, Germany

Novartis Investigative Site

Mainz, Germany, Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Münster, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29974963 (View on PubMed)

Other Identifiers

2011-004216-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIGE025E2201

Identifier Type: -

Identifier Source: org_study_id