Phase 2 N=40 Randomized Quadruple-blind Treatment

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

Perennial Allergic Rhinoconjunctivitis · House Dust Mite Allergy

Bottom Line

View on ClinicalTrials.gov: NCT00574704 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jul 2013

Primary outcome: Primary: 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) — 10; 10; 10; 1 Factor of Increased Allergen Tolerance

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) (Drug); House dust mite allergen extract in combination with CYT003-QbG10-placebo (Drug); CYT003-AllQbG10 in combination with house dust mite allergen extract placebo (Drug); CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cytos Biotechnology AG
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	10; 10; 10; 1	—
SECONDARY Safety and Tolerability of the Study Treatment by Collection of Adverse Events	—	—

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

Eligibility Criteria

Inclusion Criteria

Mild to moderate perennial allergic rhinoconjunctivitis 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00574704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.