Perennial Allergic RhinoconjunctivitisPhase 1/2NCT00652223
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
A Phase 1/2 study testing CYT005-AllQbG10 in people with Perennial Allergic Rhinoconjunctivitis and Allergic Asthma, run by Cytos Biotechnology AG at 1 site in Switzerland.
Trial summary
The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Perennial Allergic Rhinoconjunctivitis, Allergic Asthma
- What is being tested?
- CYT005-AllQbG10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2005to Nov 2005
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
- Mild asthma
- Females only if non-reproductive or agree to practice an effective and accepted method of contraception
Who cannot join
- Relevant cardiovascular, renal, pulmonary or endocrine disease
- History of autoimmune disease
- Severe allergies
- History of active infectious disease
- Current diagnosis or history of malignancy
- Relevant neurological or psychiatric disorder
Show all 10Show fewer
- Pregnancy or lactation
- History of alcohol abuse or other recreational drugs
- Use of an investigational drug within three month before enrolment
- Blood donation within 30 days before enrolment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Official title: Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.
- Being tested
- CYT005-AllQbG10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT005-AllQbG10Biological
Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CYT005-AllQbG10 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2005
- Study completionNov 2005
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philipp Mueller, MD, Study director, Cytos Biotechnology AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652223
- Sponsor's protocol ID
- CYT005-AllQbG10 01
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
- ClinicalTrials.gov ID
- NCT00652223
- Acronym / sponsor ID
- CYT005-AllQbG10 01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 3 Apr 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 the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CYT005-AllQbG10 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
- Mild asthma
- Females only if non-reproductive or agree to practice an effective and accepted method of contraception
Key exclusion criteria (10 listed)
- Relevant cardiovascular, renal, pulmonary or endocrine disease
- History of autoimmune disease
- Severe allergies
- History of active infectious disease
- Current diagnosis or history of malignancy
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-AllQbG10Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT | Biological | 1 |
Primary outcome
Not reported in the source record.
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 9 Apr 2008.
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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 AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYT005-AllQbG10 in people with Perennial Allergic Rhinoconjunctivitis and Allergic Asthma, 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 3 inclusion and 10 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 9 Apr 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 9 Apr 2008.