## Protocol Section
### Identification Module
**NCT ID:** NCT00718679

**Acronym:** IVN-CAT-001B

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

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

#### Organization Study ID Info
**ID:** IVN-CAT-001B
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-02-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-02-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Start Date
**Date:** 2008-07

**Status Verified Date:** 2010-02

#### Study First Post Date
**Date:** 2008-07-21
**Type:** ESTIMATED
**Study First Submit Date:** 2008-07-18
**Study First Submit QC Date:** 2008-07-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** ImVision GmbH, Hannover

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Zurich

#### Responsible Party

**Old Name Title:** PD Dr. Thomas Kündig

**Old Organization:** University Hospital Zurich

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Allergy to Cat Dander

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Study drug

**Intervention Names:**

- Drug: IVN201

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo

**Intervention Names:**

- Drug: Placebo

**Label:** 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Intralymphativ injection of the study drug

**Name:** IVN201

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Saftety tolerability and efficacy

**Time Frame:** 2009

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zurich

**Country:** Switzerland

**Facility:** Center for Clinical Research University Hospital Zurich

#### Overall Officials

**Official 1:**

**Affiliation:** UniversitaetsSpital Zuerich

**Name:** Gabriela Senti, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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

**Citation:** 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 Section

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
