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Hay FeverPhase 3NCT02560948

Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

A Phase 3 study testing gpASIT+TM in people with Hay Fever, run by BioTech Tools S.A. at 3 sites in 3 countries.

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 study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Hay Fever
What is being tested?
gpASIT+TM
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
554 participants
Where
3 sitesin 3 countries
Study dates
Dec 2015to Aug 2016
Phase
Phase 3
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Allergy diagnosis:
  • A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
  • A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm
  • Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L
  • Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens
  • Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
  • For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)

Who cannot join

  • Previous immunotherapy with grass allergens within the last 5 years
  • Ongoing immunotherapy with grass allergens or any other allergens
  • Patients with a history of anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
  • Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
  • Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
  • Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
  • Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Belgium1 site

  • University Hospital Ghent

    Ghent

Other trials in Belgium

Italy1 site

  • Clinica dell'Azienda Opsedaliera Luigi Sacco

    Milan

Other trials in Italy

Spain1 site

  • Fundacion Jiménez Diaz

    Madrid

Other trials in Spain

About this study

Official title: A Multicenter, International, Randomised, Double-blind, Placebo Controlled Study to Demonstrate the Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo.

Conditions
Hay Fever
Being tested
Placebo solution, gpASIT+TM
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.

  • Placebo solutionBiological

    4 x 2 injections over 21 days

  • gpASIT+TMBiological

    4 x 2 injections over 21 days

Study groups in NCT02560948
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo solution
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. Combined Symptom and Medication Score (CSMS)

    Measured: over the peak (corresponding to 14 consecutive days with highest pollen counts) of grass pollen season estimated between 3 and 6 months after treatment

Secondary outcomes (15)

  1. Combined Symptom and Medication Score (CSMS)

    Measured: over the entire grass pollen season estimated between 3 and 6 months after treatment

  2. Symptom sub-scores (Eyes, Nose)

    Measured: over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment

  3. Well days: number of days with symptomatic score below or equal to 2 and no rescue medication

    Measured: over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment

  4. Lung Symptom Score (LLS: the average of coughing, wheezing, chest tightness and exercise induced dyspnoea scores) in asthmatic patients

    Measured: over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment

  5. Total Symptom Score (TSS: the sum of the nose, eye and lung scores) in asthmatic patients

    Measured: over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment

  6. Use of rescue medication to relief asthma symptoms in asthmatic patients

    Measured: over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment

  7. Conjunctival Provocation Test (CPT) outcomes

    Measured: at baseline and up to 6 weeks

  8. Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis

    Measured: between 2 weeks and 8 months after treatment

  9. Number of working day lost due to grass pollen induced-allergy symptoms

    Measured: between 2 weeks and 8 months after treatment

  10. Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS)

    Measured: between 2 weeks and 8 months after treatment

  11. Solicited adverse events

    • Local reactions at the injection site (swelling and redness)
    • Allergic systemic reactions

    Measured: up to 4 weeks

  12. Unsolicited adverse events and serious adverse events

    Measured: up to 8 months

  13. Physical examinations and vital signs

    Measured: up to 8 months

  14. Laboratory investigations (haematology, clinical biochemistry, immunological parameters)

    Measured: up to 8 months

  15. Use of rescue medication

    Measured: up to 4 weeks

Timeline

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

  1. First posted25 Sep 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560948
Sponsor's protocol ID
BTT-gpASIT009
Status last verified
Sep 2015
First submitted
23 Sep 2015
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Sharif H, Singh I, Kouser L, Mosges R, Bonny MA, Karamani A, Parkin RV, Bovy N, Kishore U, Robb A, Katotomichelakis M, Holtappels G, Derycke L, Corazza F, von Frenckell R, Wathelet N, Duchateau J, Legon T, Pirotton S, Durham SR, Bachert C, Shamji MH. Immunologic mechanisms of a short-course of Lolium perenne peptide immunotherapy: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2019 Sep;144(3):738-749. doi: 10.1016/j.jaci.2019.02.023. Epub 2019 Mar 5.

    PubMed 30844425

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gpASIT+TM in people with Hay Fever, run by BioTech Tools S.A. at 3 sites in 3 countries.

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 7 inclusion and 7 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Italy, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Combined Symptom and Medication Score (CSMS) (time frame: over the peak (corresponding to 14 consecutive days with highest pollen counts) of grass pollen season estimated between 3 and 6 months after treatment). 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 NCT02560948, which also lists 1 linked publication.

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 11 Oct 2018.

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