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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01599637
First received: January 25, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Chronic Idiopathic Urticaria
Drug: IGE025
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in FcεRI/IgE positive skin cells [ Time Frame: Baseline through Day 85 post-treatment ] [ Designated as safety issue: No ]
    FcεRI/IgE positive skin cells will be measured from skin biopsies collected at baseline (pre-treatment) and then on Day 8 and at time points through Day 85.


Secondary Outcome Measures:
  • Change in FcεRI/ IgE on positive skin cells with respect to UAS7 score [ Time Frame: Baseline through Day 85 ] [ Designated as safety issue: No ]
  • Change in skin cell immune system markers [ Time Frame: Baseline through Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Change in common blood cells [ Time Frame: Baseline through Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Differences between affected and unaffected skin samples [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Serum levels of omalizumab [ Time Frame: Baseline through Day 85 ] [ Designated as safety issue: No ]
  • Serum total and free IgE [ Time Frame: Baseline through Day 85 ] [ Designated as safety issue: No ]
  • Specific IgE [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Urticaria activity score (UAS7) [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Likert scale [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Assessment of angioedema [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index (DLQI) [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Skindex-29 [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: No ]
  • Number of participants with adverse events, serious adverse events or death [ Time Frame: Day 140 post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGE025
Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center.
Drug: IGE025
Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
Placebo Comparator: Placebo to IGE025
Placebo administered subcutaneously every 4 weeks at the study center.
Drug: placebo
Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599637

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Muenster, Germany, 48149
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01599637     History of Changes
Other Study ID Numbers: CIGE025E2201, 2011-004216-31
Study First Received: January 25, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Chronic idiopathic urticaria
CIU
Xolair
IGE025
FcεRI
IgE

Additional relevant MeSH terms:
Urticaria
Omalizumab
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014