Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

C

Cytos Biotechnology

Status and phase

Completed
Phase 2

Conditions

Rhinoconjunctivitis
Allergies

Treatments

Drug: CYT003-QbG10
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00800332
CYT003-QbG10 09

Details and patient eligibility

About

The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
  • Further criteria as defined in the study protocol

Exclusion criteria

  • Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
  • Clinically relevant perennial allergy/-ies other than house dust mites allergy
  • Contraindication to any study test or procedure
  • Further criteria as defined in the study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 3 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: CYT003-QbG10
2
Experimental group
Treatment:
Drug: CYT003-QbG10
3
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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