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

C

Cytos Biotechnology

Status and phase

Completed
Phase 2

Conditions

Perennial Allergic Rhinoconjunctivitis
House Dust Mite Allergy

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00574704
CYT005-AllQbG10 03

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 4 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
2
Placebo Comparator group
Treatment:
Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
3
Experimental group
Treatment:
Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
4
Placebo Comparator group
Treatment:
Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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