CClinicalTrials.gg
CompletedNCT00800332Updated Nov 15, 2010

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

A Phase 2 interventional study of CYT003-QbG10 and Placebo in Rhinoconjunctivitis and Allergies, sponsored by Cytos Biotechnology AG. Completed at 8 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-11-15.

Sponsored by Cytos Biotechnology AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rhinoconjunctivitis
  • Allergies

Keywords

  • Rhinoconjunctivitis due to house dust mite allergy
03

In context

Dust Mite Allergy

47 studies on the registry are indexed under Dust Mite Allergy; 6 are open to participants now.

This study's planned enrollment of 300 is above the median of 66 across 36 interventional studies indexed under Dust Mite Allergy.

Browse Dust Mite Allergy studies →

Lead sponsor

Cytos Biotechnology AG is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    1

    Drug: CYT003-QbG10

  • Experimental
    2

    Drug: CYT003-QbG10

  • Placebo comparator
    3

    Drug: Placebo

Interventions

  • DrugCYT003-QbG10

    subcutaneous injection

  • DrugPlacebo

    subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Rhinoconjunctivitis symptom and medication scores

    Time frame: Pre- / Post-Treatment

07

Study locations

8 sites
  • Cytos Investigator Sites
    Paide, Tartu, Tallin, Rakvere, Estonia
  • Cytos Investigator Sites
    Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach, Germany
  • Cytos Investigator Sites
    Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen, Germany
  • Cytos Investigator Sites
    N. Faliro, Hiraklion, Athens, Greece
  • Cytos Investigator Sites
    Riga, Rezekne, Latvia
  • Cytos Investigator Sites
    Vilnius, Kaunas, Klaipeda, Lithuania
  • Cytos Investigator Sites
    Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti, Romania
  • Cytos Investigator Sites
    Targu Mures, Bukarest, Craiova, Iasi, Romania
08

References and documents

Publications

  • Klimek L, Willers J, Hammann-Haenni A, Pfaar O, Stocker H, Mueller P, Renner WA, Bachmann MF. Assessment of clinical efficacy of CYT003-QbG10 in patients with allergic rhinoconjunctivitis: a phase IIb study. Clin Exp Allergy. 2011 Sep;41(9):1305-12. doi: 10.1111/j.1365-2222.2011.03783.x. Epub 2011 Jun 14. PubMed 21672053 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00800332
Lead sponsor
Cytos Biotechnology AG
First posted
Dec 2, 2008
Start date
Nov 2008
Primary completion
Apr 2010
Completion
Nov 2010
Last update
Nov 15, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion