Seasonal Allergic RhinoconjunctivitisPhase 1NCT01111279
Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis
A Phase 1 study testing gpASIT+TM and gpAST+TM/adjuvant in people with Seasonal Allergic Rhinoconjunctivitis, run by BioTech Tools S.A. at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seasonal Allergic Rhinoconjunctivitis
- What is being tested?
- gpASIT+TM and gpAST+TM/adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has given written informed consent
- Age between 18 and 50 years
- The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- Male or non pregnant, non-lactating female
- Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
- Allergy diagnosis:
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- A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least during the two previous years
- A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture
- Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l)
- Asymptomatic to perennial inhalant allergens even if shown to be hypersensitive in a skin prick test.
Who cannot join
- Subjects with current or past immunotherapy (any time in the past)
- A history of hypersensitivity to the excipients
- Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
- Subjects with a history of hepatic or renal disease
- Subjects symptomatic to perennial inhalant allergens
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- Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
- Subject with malignant disease, autoimmune disease (and family medical history of autoimmune disease)
- Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)
- Subjects requiring beta-blockers medication
- Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
- Subject with febrile illness (> 37.5°C, oral)
- A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
- The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
- Receipt of blood or a blood derivative in the past 6 months preceding trial entry
- Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
- Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
- Use of long-acting antihistamines
- Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
- Any condition which could be incompatible with protocol understanding and compliance
- Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
- Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
- Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
- Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
- Subjects who participated to trial BTT-gpASIT003 and were in the treated groups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis
The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Being tested
- gpASIT+TM, gpAST+TM/adjuvant, Placebo solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gpASIT+TMBiological
1 subcutaneous injection every 7 days, during 29 days.
gpAST+TM/adjuvantBiological
1 subcutaneous injection every 7 days, during 29 days
Placebo solutionBiological
1 subcutaneous injection every 7 days, during 29 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo solution |
| gpASIT+TM | Experimental | Not described Receives: Biological: gpASIT+TM |
| gpASIT+TM/adjuvant | Experimental | Not described Receives: Biological: gpAST+TM/adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical tolerability and safety of the treatment
The following parameters will be assessed : general physical status, vital signs, haematological parameters , general blood biochemistry parameters, all (serious) adverse, immunological analysis (total IgG, total IgE) and inflammatory parameters (CRP, sedimentation rate)
Measured: 3 times during the treatment phase, at week 24 (the end of the study)
Secondary outcomes (2)
Impact of gpASIT+TM on the immunological status of the subjects
The following parameters will be assessed :
- allergen-specific IgE, IgG, IgG4, IgA antibody concentrations,
- adjuvant-specific IgG antibody concentrations,
- lymphoproliferation and production of IL-10 in allergen and adjuvant stimulated PBMC.
Measured: visit 1, week 7, week 18 and week 24
Impact of gpASIT+TM on the clinical status of the subjects
The following parameters will be assessed (during the pollen season following treatment):
- daily average allergic symptom score,
- daily average allergic medication score,
- number of "well-days",
- Visual Analogue Scale .
Measured: 1 May - 15 August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioTech Tools S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Ceuppens, Professor, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111279
- Sponsor's protocol ID
- BTT-gpASIT004
- Status last verified
- Feb 2011
- First submitted
- 20 Apr 2010
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01111279
- Acronym / sponsor ID
- BTT-gpASIT004
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- BioTech Tools S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Apr 2010 (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 this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.
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 |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo solution |
| gpASIT+TM | Experimental | Biological: gpASIT+TM |
| gpASIT+TM/adjuvant | Experimental | Biological: gpAST+TM/adjuvant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject has given written informed consent
- Age between 18 and 50 years
- The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- Male or non pregnant, non-lactating female
- Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
Key exclusion criteria (25 listed)
- Subjects with current or past immunotherapy (any time in the past)
- A history of hypersensitivity to the excipients
- Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
- Subjects with a history of hepatic or renal disease
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 |
|---|---|---|
| gpASIT+TM1 subcutaneous injection every 7 days, during 29 days. | Biological | gpASIT+TM |
| gpAST+TM/adjuvant1 subcutaneous injection every 7 days, during 29 days | Biological | gpASIT+TM/adjuvant |
| Placebo solution1 subcutaneous injection every 7 days, during 29 days | Biological | Placebo |
Primary outcome
Clinical tolerability and safety of the treatment
Time frame: 3 times during the treatment phase, at week 24 (the end of the study)
The following parameters will be assessed : general physical status, vital signs, haematological parameters , general blood biochemistry parameters, all (serious) adverse, immunological analysis (total IgG, total IgE) and inflammatory parameters (CRP, sedimentation rate)
2 secondary outcomes
Impact of gpASIT+TM on the immunological status of the subjects
Time frame: visit 1, week 7, week 18 and week 24
Impact of gpASIT+TM on the clinical status of the subjects
Time frame: 1 May - 15 August 2010
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 1 Mar 2011.
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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.
Jan Ceuppens, Professor principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gpASIT+TM and gpAST+TM/adjuvant in people with Seasonal Allergic Rhinoconjunctivitis, run by BioTech Tools S.A. at 1 site in Belgium.
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 10 inclusion and 25 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 1 Mar 2011. 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 Belgium. 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 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.
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?
Clinical tolerability and safety of the treatment (time frame: 3 times during the treatment phase, at week 24 (the end of the study)). 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 1 Mar 2011.