Perennial Allergy to House Dust Mite and/or CatPhase 2NCT00575003
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
A Phase 2 study testing CYT003-QbG10 in people with Perennial Allergy to House Dust Mite and/or Cat, run by Cytos Biotechnology AG at 7 sites in 3 countries.
Trial summary
The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergy to House Dust Mite and/or Cat
- 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
- 64 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Dec 2007to Mar 2009
- 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
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens
Who cannot join
- Clinical 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.
- Any clinically relevant concomitant disease as judged by the investigator.
- Pregnancy or female planning to become pregnant during the study.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Lithuania3 sites
Kaunas County Hospital, Department of Pulmonology and Allergology
Kaunas, 45130
Kaunas Medical University Hospital, Department of Pulmonology and Immunology
Kaunas, 50009
Vilnius University Hospital, Centre of Pulmonology and Allergology
Vilnius, 08661
Estonia2 sites
Tartu University Clinic, Out-Patients Department
Tartu, 50406
Tartu University Clinic, Lungs Clinic
Tartu, 51014
Latvia2 sites
The centre of the investigation in treatment of allergic disease
Riga, 1003
SNC Uniclinica
Riga, 1010
About this study
Official title: Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis
The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.
- Being tested
- CYT003-QbG10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT003-QbG10Drug
6 subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CYT003-QbG10 |
| 2 | Placebo comparator | Not described Receives: Drug: CYT003-QbG10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Measured: on 4 occations over 1 year
Secondary outcomes (1)
Safety and tolerability of the vaccine by collection of adverse events
Measured: at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergy to House Dust Mite and/or CatStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Audra Blaziene, Principal investigator, Vilnius University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575003
- Sponsor's protocol ID
- CYT003-QbG10 08
- Status last verified
- Apr 2009
- First submitted
- 14 Dec 2007
- Last updated
- 27 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00575003
- Acronym / sponsor ID
- CYT003-QbG10 08
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Dec 2007 (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 the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CYT003-QbG10 |
| 2 | Placebo comparator | Drug: CYT003-QbG10 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens
Key exclusion criteria (4 listed)
- Clinical 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.
- Any clinically relevant concomitant disease as judged by the investigator.
- Pregnancy or female planning to become pregnant during the study.
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-QbG106 subcutaneous injections | Drug | 1, 2 |
Primary outcome
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Time frame: on 4 occations over 1 year
1 secondary outcome
Safety and tolerability of the vaccine by collection of adverse events
Time frame: at each visit
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 27 Apr 2009.
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.
Audra Blaziene principal investigator
Vilnius University Hospital
7 sites in 3 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 Perennial Allergy to House Dust Mite and/or Cat, run by Cytos Biotechnology AG at 7 sites in 3 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 1 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 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Lithuania, Estonia, Latvia. 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?
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life (time frame: on 4 occations over 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2009.