Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

NCT00718679 | Completed Phase 1

• 1 other identifier: IVN-CAT-001B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients

Conditions

Allergy to Cat Dander

Outcome Measures

Primary Outcomes (1)

• Saftety tolerability and efficacy

  2009

Study Arms (2)

1

EXPERIMENTAL

Study drug

Drug: IVN201

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IVN201 DRUG

Intralymphativ injection of the study drug

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History and subjective symptoms of cat dander allergy including cat specific allergic rhinitis
• Age 18 to 65 years
• Positive reaction to at least one concentration of cat dander allergen in skin prick test, intradermal provocation test and nasal provocation test

You may not qualify if:

• Chronic infectious disease
• Acute infections
• Episode of non-allergic rhinitis within the last 4 weeks
• Use of allergen known to predict anaphylactic reactions
• Treatment with any other investigational drug within 3 months before trial entry
• Vaccination within the last week
• Nasal surgery within the last 8 weeks
• Progressive fatal disease
• Drug or alcohol abuse within the last 5 years
• Cat ownership
• A history of significant cardiac insufficiency (NYHA stage III-IV)
• Coexisting severe disease, e.g. cardiovascular diseases
• Acute or history of obstructive respiratory insufficiency ( FEV1 \<70%)
• Hepatic insufficiency
• Relevant anaemia (as judged by investigator)

Sponsors & Collaborators

• University of Zurich: lead
• ImVision GmbH, Hannover: collaborator

Study Sites (1)

Center for Clinical Research University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (2)

• Freiberger SN, Zehnder M, Gafvelin G, Gronlund H, Kundig TM, Johansen P. IgG4 but no IgG1 antibody production after intralymphatic immunotherapy with recombinant MAT-Feld1 in human. Allergy. 2016 Sep;71(9):1366-70. doi: 10.1111/all.12946. Epub 2016 Jun 17.

  PMID: 27253988 DERIVED

• Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.

  PMID: 22464647 DERIVED

Study Officials

• Gabriela Senti, MD

  UniversitaetsSpital Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 11, 2010

Record last verified: 2010-02

Locations

CH (1)