- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111279
Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis
February 28, 2011 updated by: BioTech Tools S.A.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium, 3000
- UZ Leuven, Gasthuisberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
1 subcutaneous injection every 7 days, during 29 days
|
Experimental: gpASIT+TM
|
1 subcutaneous injection every 7 days, during 29 days.
|
Experimental: gpASIT+TM/adjuvant
|
1 subcutaneous injection every 7 days, during 29 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
3 times during the treatment phase, at week 24 (the end of the study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of gpASIT+TM on the immunological status of the subjects
Time Frame: visit 1, week 7, week 18 and week 24
|
The following parameters will be assessed :
|
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
|
The following parameters will be assessed (during the pollen season following treatment):
|
1 May - 15 August 2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Ceuppens, Professor, UZ Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
April 20, 2010
First Submitted That Met QC Criteria
April 26, 2010
First Posted (Estimate)
April 27, 2010
Study Record Updates
Last Update Posted (Estimate)
March 1, 2011
Last Update Submitted That Met QC Criteria
February 28, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTT-gpASIT004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Seasonal Allergic Rhinoconjunctivitis
-
BioTech Tools S.A.CompletedSeasonal Allergic RhinoconjunctivitisBelgium
-
BioTech Tools S.A.CompletedSeasonal Allergic RhinoconjunctivitisBelgium
-
Menarini International Operations Luxembourg SACompletedAsthma | Seasonal Allergic RhinoconjunctivitisPoland, Romania, Germany, Italy, Czechia, Latvia, Croatia, Slovakia
-
Allergy TherapeuticsCompletedSeasonal Allergic Rhinitis | RhinoconjunctivitisUnited States, Germany, Austria, Hungary, Czechia, Poland
-
Medical University of GrazRecruiting
-
Immunomic Therapeutics, Inc.Completed
-
University of ZurichCompletedAllergic RhinoconjunctivitisSwitzerland
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisSpain
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisSpain
-
Immunomic Therapeutics, Inc.CompletedAllergic RhinoconjunctivitisUnited States
Clinical Trials on Placebo solution
-
Eli Lilly and CompanyCompletedDiabetes Mellitus, Type 2Singapore
-
Eli Lilly and CompanyCompletedSleep Initiation and Maintenance DisordersJapan
-
EyePoint Pharmaceuticals, Inc.Medical Technology Enterprise Consortium (MTEC)TerminatedCOVID-19 | Acute Respiratory Distress Syndrome (ARDS)United States
-
Hangzhou Sciwind Biosciences Co., Ltd.Completed
-
Jewish General HospitalNot yet recruitingRight Ventricular Dysfunction | Left Ventricular Dysfunction | Quality of RecoveryCanada
-
Kowa Research Institute, Inc.CompletedFuchs' Endothelial Corneal DystrophyUnited States, Australia, Germany, Spain, Denmark
-
BayerCompleted
-
Pharmosa Biopharm Inc.Novotech (Australia) Pty LimitedRecruitingPulmonary Arterial HypertensionAustralia
-
Boehringer IngelheimRecruitingNetherton SyndromeBelgium, United Kingdom, Australia, Germany, China, Malaysia, Japan, France, United States, Israel, Bulgaria, Italy, Switzerland, Austria, Netherlands, Portugal
-
Boehringer IngelheimCompleted