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Hay FeverPhase 2NCT02156791

Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM

A Phase 2 study testing gpASIT+TM in people with Hay Fever, run by BioTech Tools S.A. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this clinical trial is to confirm the safety, clinical tolerability and immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with grass pollen-induced allergic… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hay Fever
What is being tested?
gpASIT+TM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteGermany
Study dates
Aug 2013to Dec 2013
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated Informed Consent Form by a legally competent patient
  • Female or male patients aged 18-70 years
  • The patients are in good physical and mental health according to his/her medical history and vital signs
  • Non-pregnant, non-lactating females with adequate contraception
  • Females unable to bear children must have signed the form for adequate contraceptive protection (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 medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) for the grass pollen season during at least the two previous years
  • A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction ≤ 2 mm
  • Specific IgE against grass pollen (IgE > 0.7 kU/l)
  • Patients treated with anti-allergic medication for at least 2 years prior to enrolment
  • In asthmatic patients:
  • Confirmed diagnosis of controlled asthma according to GINA-guidelines (GINA 2011)

Who cannot join

  • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
  • Previous immunotherapy with grass allergens within the last 5 years
  • Ongoing immunotherapy
  • Patients being in any relationship or dependence with the Sponsor and/ or Investigator
  • Inability to understand instructions/ study documents
  • Patients with a history of hypersensitivity to the excipients of investigational products
Show all 24Show fewer
  • Patients with partly controlled or uncontrolled asthma
  • Chronic asthma or emphysema, particularly with a FEV 1 <80% of the predicted value (ECSC)
  • Patients symptomatic to perennial inhalant allergens to which the subjects are regularly exposed
  • Patients with a history of ragweed allergy
  • Patients with a history of renal disease or chronic hepatic disease
  • Patients with malignant disease
  • Patients with a know severe autoimmune disease and patients with a positive test to ANA, ANCA or ASCA
  • Patients with any chronic disease which may impair the patient's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
  • Patients requiring beta-blockers/ACE-inhibitors medication
  • Patients requiring anti-IgE antibodies, mast cell stabilizers, and antileukotriene agents
  • Patients with any contraindication for the use of adrenaline
  • Patients with febrile illness (> 37.5°C, oral)
  • Patients with a known positive serology for HIV-1/2, HBV or HCV
  • Patients who are immunocompromised by medication or illness, have received a vaccine corticoids or immunosuppressive medications within 1 month before trial entry
  • Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
  • Consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 3 weeks preceding the trial (screening visit)
  • Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007)
  • Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany

    Dresden, 01307

Other trials in Germany

About this study

Official title: Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM Administered Subcutaneously to Hay Fever Patients

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this clinical trial is to confirm the safety, clinical tolerability and immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated dose of gpASIT+TM .

Conditions
Hay Fever
Being tested
gpASIT+TM
Keywords
Seasonal allergic rhinoconjunctivitis, Grass pollen, Allergen specific immunotherapy
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gpASIT+TMBiological

Study groups in NCT02156791
Study groupRoleWhat they receive
gpASIT+TMExperimentalNot described
Receives: Biological: gpASIT+TM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (Serious) adverse events

    Measured: Up to 6 weeks

Secondary outcomes (6)

  1. Grass pollen allergen -specific immunoglobulins

    Measured: up to 6 weeks

  2. Blocking antibody production

    Measured: up to 6 weeks

  3. Change from baseline in Conjunctival Provocation Test score

    Measured: at screening, after 4 weeks and 6 weeks of treatment

  4. Local reaction at the injection site

    Measured: up to 6 weeks

  5. Systemic reaction after injection

    Measured: up to 6 weeks

  6. Change from baseline in safety laboratory parameters

    Measured: up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156791
Sponsor's protocol ID
BTT-gpASIT007
Status last verified
May 2014
First submitted
23 May 2014
Last updated
6 Jun 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gpASIT+TM in people with Hay Fever, run by BioTech Tools S.A. at 1 site in Germany.

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 12 inclusion and 24 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 6 Jun 2014. 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 Germany. 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 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?

(Serious) adverse events (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02156791.

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 6 Jun 2014.

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