A Study to Investigate an Immunomodulatory Therapy in Adu... | NCT00574223

Studies
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

NCT00574223

Sponsor

Cytos Biotechnology AG

Status

Completed

Last Update Posted

Apr 27, 2009Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Perennial Allergic Rhinoconjunctivitis
House Dust Mite Allergy

Interventions

CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
House dust mite allergen extract in combination with CYT003-QbG10-placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Official Title

Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Dec 14, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2009

Last Update Posted Date

Apr 27, 2009Estimated

Description Module

Brief Summary

The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
Arm 2	Placebo Comparator		Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)	Drug	subcutaneous injections at 8 visits	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life		about 1.5 hours on 4 occasions over 1 year

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of the study treatment by collection of adverse events		about 30 min. at each visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
Use of any concomitant medication that could affect the patient's study treatment response or assessment results

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philipp Mueller, MD	Cytos Biotechnology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cytos Biotechnology (Sponsor's Headquarter)		Schlieren		CH-8952	Switzerland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000092542	Dust Mite Allergy

Ancestor Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000941	Antigens
D001685	Biological Factors

ID	Term
C559986	CYT003-QbG10
D039741	Antigens, Dermatophagoides