Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial (IVN-CAT-001B)

University of Zurich (UZH)

Status and phase: Completed; Phase 1

Conditions: Allergy to Cat Dander

Treatments: Drug: Placebo; Drug: IVN201

Study type: Interventional

Funder types: Other

Identifiers

NCT00718679

IVN-CAT-001B

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Study drug

Treatment:

Drug: IVN201

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo