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

NCT00574704 | Completed Phase 2 Results

• 1 other identifier: CYT005-AllQbG10 03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

• Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)

  The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was \<10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.

  baseline versus 2 months after baseline

Secondary Outcomes (1)

• Safety and Tolerability of the Study Treatment by Collection of Adverse Events

  about 30 min. at each visit

Study Arms (4)

1

EXPERIMENTAL

Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)

2

PLACEBO COMPARATOR

Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo

3

EXPERIMENTAL

Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo

4

PLACEBO COMPARATOR

Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo

Interventions

CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) DRUG

subcutaneous injections at 6 visits

1

House dust mite allergen extract in combination with CYT003-QbG10-placebo DRUG

subcutaneous injections at 6 visits

2

CYT003-AllQbG10 in combination with house dust mite allergen extract placebo DRUG

subcutaneous injections at 6 visits

3

CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo DRUG

subcutaneous injections at 6 visits

4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytos Biotechnology AG: lead

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

CYT003-QbG10; Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Results Point of Contact

• Title: Head of Clinical Develpment
• Organization: Cytos Biotechnology AG

info@cytos.com

+41 44 733 4

Study Officials

• Philipp Mueller, MD

  Cytos Biotechnology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: September 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 11, 2013
• Results First Posted: July 11, 2013

Record last verified: 2013-02