RhinoconjunctivitisPhase 2NCT00800332
Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy
A Phase 2 study testing CYT003-QbG10 in people with Rhinoconjunctivitis and Allergies, run by Cytos Biotechnology AG at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis, Allergies
- What is being tested?
- CYT003-QbG10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Nov 2008to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
- Further criteria as defined in the study protocol
Who cannot join
- 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 locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Germany2 sites
Cytos Investigator Sites
Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach
Cytos Investigator Sites
Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen
Romania2 sites
Cytos Investigator Sites
Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti
Cytos Investigator Sites
Targu Mures, Bukarest, Craiova, Iasi
About this study
Official title: Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
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.
- Conditions
- Rhinoconjunctivitis, Allergies
- Being tested
- CYT003-QbG10, Placebo
- Keywords
- Rhinoconjunctivitis due to house dust mite allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT003-QbG10Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CYT003-QbG10 |
| 2 | Experimental | Not described Receives: Drug: CYT003-QbG10 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinoconjunctivitis symptom and medication scores
Measured: Pre- / Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800332
- Sponsor's protocol ID
- CYT003-QbG10 09
- Status last verified
- Nov 2010
- First submitted
- 1 Dec 2008
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
- ClinicalTrials.gov ID
- NCT00800332
- Acronym / sponsor ID
- CYT003-QbG10 09
- Conditions
- Rhinoconjunctivitis, Allergies
- Keywords
- Rhinoconjunctivitis due to house dust mite allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CYT003-QbG10 |
| 2 | Experimental | Drug: CYT003-QbG10 |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
- Further criteria as defined in the study protocol
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT003-QbG10subcutaneous injection | Drug | 1, 2 |
| Placebosubcutaneous injection | Drug | 3 |
Primary outcome
Rhinoconjunctivitis symptom and medication scores
Time frame: Pre- / Post-Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- Derived from this study: PubMed 21672053Klimek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT003-QbG10 in people with Rhinoconjunctivitis and Allergies, run by Cytos Biotechnology AG at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Romania, Estonia, Greece, Latvia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinoconjunctivitis symptom and medication scores (time frame: Pre- / Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00800332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.