Perennial Allergic RhinoconjunctivitisPhase 2NCT00574223
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
A Phase 2 study testing CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) in people with Perennial Allergic Rhinoconjunctivitis and House Dust Mite Allergy, run by Cytos Biotechnology AG at 1 site in Switzerland.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
- What is being tested?
- CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 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 rhinoconjunctivits due to hypersensitization towards house dust mite allergens
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, CH-8952
About this study
Official title: Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy
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
- Being tested
- CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10), House dust mite allergen extract in combination with CYT003-QbG10-placebo
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)Drug
subcutaneous injections at 8 visits
House dust mite allergen extract in combination with CYT003-QbG10-placeboDrug
subcutaneous injections at 8 visits
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo |
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: about 1.5 hours on 4 occasions over 1 year
Secondary outcomes (1)
Safety and tolerability of the study treatment by collection of adverse events
Measured: about 30 min. 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 startNov 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 Allergic 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philipp Mueller, MD, Study director, Cytos Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574223
- Sponsor's protocol ID
- CYT005-AllQbG10 04
- 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 Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy
- ClinicalTrials.gov ID
- NCT00574223
- Acronym / sponsor ID
- CYT005-AllQbG10 04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Nov 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 the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting
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 |
|---|---|---|
| Arm 1 | Experimental | Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) |
| Arm 2 | Placebo comparator | Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo |
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 rhinoconjunctivits due to hypersensitization towards house dust mite allergens
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)subcutaneous injections at 8 visits | Drug | Arm 1 |
| House dust mite allergen extract in combination with CYT003-QbG10-placebosubcutaneous injections at 8 visits | Drug | Arm 2 |
Primary outcome
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Time frame: about 1.5 hours on 4 occasions over 1 year
1 secondary outcome
Safety and tolerability of the study treatment by collection of adverse events
Time frame: about 30 min. 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.
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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.
Philipp Mueller, MD study director
Cytos Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) in people with Perennial Allergic Rhinoconjunctivitis and House Dust Mite Allergy, run by Cytos Biotechnology AG at 1 site in Switzerland.
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 2 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 1 site in Switzerland. 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: about 1.5 hours on 4 occasions 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.