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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718679

Acronym

IVN-CAT-001B

Enrollment

Registered

2008-07-21

Start date

2008-07-31

Completion date

2010-02-28

Last updated

2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy to Cat Dander

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

Interventions

DRUGIVN201

Intralymphativ injection of the study drug

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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) * Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation) * Pregnancy or breast feeding * Sexually active woman of childbearing potential not actively practicing birth control by using a medically accepted device or therapy * Lack of compliance or other sililar reason, that the investigator believes, precludes satisfactory participation in the study * Systemic glucocorticoid therapy * Allergic asthma and chronic medication with steroids at doses exceeding 200ug/day Treatment with ATII antagonists, B-blocker, ACE inhibitors

Design outcomes

Primary

Measure	Time frame
Saftety tolerability and efficacy	2009

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026