Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

NCT01308021 | Completed Phase 2

• 1 other identifier: BTT-gpASIT005
• Study Type: interventional
• Target: 202
• Locations: 3 countries
• Sites: 19

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

Conditions

Grass Pollen Allergy; Hay Fever

Keywords

Rhinoconjunctivitis; Allergy; Grass pollen; Hypersensitivity; Immune system disorder

Outcome Measures

Primary Outcomes (1)

• Impact of gpASIT+TM on the clinical efficacy of the subjects

  The following parameter will be assessed: rhinoconjunctivitis total symptom score

  grass pollen season 2011 (April to July)

Secondary Outcomes (4)

• Clinical tolerability and safety of the treatment

  8 months

• Impact of gpASIT+TM on the immunological status of the subjects

  screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)

• Impact of gpASIT+TM on the clinical status of the subjects

  grass pollen season 2011 (April-July)

• Impact of gpASIT+TM on the quality of life of the subjects

  grass pollen season 2011 (April-July)

Study Arms (3)

gpASIT400

EXPERIMENTAL

gpASIT+TM 400 µg

Biological: gpASIT+TM

gpASIT800

EXPERIMENTAL

gpASIT+TM 800 µg

Biological: gpASIT+TM

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

gpASIT+TM BIOLOGICAL

entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days

gpASIT400

Placebo BIOLOGICAL

Placebo entero-coated capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years
• Subject has given written informed consent
• 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
• Female 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 \> 2 years

You may not qualify if:

• Subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years
• Subjects with perennial asthma
• Subjects with a VC \< 80% and FEV1 \< 70%
• Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
• Documented evidence of chronic sinusitis (as determined by investigator)
• Subjects with a history of hepatic or renal disease
• Subjects symptomatic to perennial inhalant allergens
• Subject with malignant disease, autoimmune disease
• Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD, ...)
• Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, 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, HBV or HCV
• The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry

Sponsors & Collaborators

• BioTech Tools S.A.: lead

Study Sites (19)

CHR Saint Joseph Warquignies

Boussu, 7300, Belgium

Location

AZ Sint Lucas

Bruges, 8310, Belgium

Location

Clinique du Parc Léopold

Brussels, 1040, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UCL Saint Luc

Brussels, 1200, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

UCL Mont Godinne

Yvoir, 5530, Belgium

Location

Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

CHRU Lille

Lille, 59037, France

Location

Private practice

Nantes, 44000, France

Location

Private practice

Nantes, 44400, France

Location

CHU Reims

Reims, 51100, France

Location

CHRU Strasbourg

Strasbourg, 67091, France

Location

CH Luxembourg

Luxembourg, 1210, Luxembourg

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity; Immune System Diseases

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Study Officials

• Claus Bachert, MD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

• Jan Ceuppens, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Didier Ebo, MD

  UZ Antwerpen

  PRINCIPAL INVESTIGATOR

• Jean-Luc Halloy, MD

  CHR Warquignies

  PRINCIPAL INVESTIGATOR

• Stijn Hallewyck, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Peter Hellings, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Renaud Louis, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

• Catherine Mbasoa, MD

  Clinique du Parc Léopold Bruxelles

  PRINCIPAL INVESTIGATOR

• Charles Pilette, MD

  UCL Saint Luc Bruxelles

  PRINCIPAL INVESTIGATOR

• Hélène Simonis, MD

  CHR Citadelle Liège

  PRINCIPAL INVESTIGATOR

• Olivier Vandenplas, MD

  UCL Mont Godinne Yvoir

  PRINCIPAL INVESTIGATOR

• Christoph Verhoye, MD

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

• Patricia Wackenier, MD

  CHU Ambroise-Paré - Mons

  PRINCIPAL INVESTIGATOR

• Frédéric De Blay, MD

  CHRU Strasbourg

  PRINCIPAL INVESTIGATOR

• Marie-Christine Castelain, MD

  Hôpital Saint Vincent de Paul, Lille

  PRINCIPAL INVESTIGATOR

• François Lavaud, MD

  CHRU Reims

  PRINCIPAL INVESTIGATOR

• Benoît Wallaert, MD

  CHU Lille

  PRINCIPAL INVESTIGATOR

• François Wessel, MD

  Private Practice Nantes

  PRINCIPAL INVESTIGATOR

• Bruno Lebeaupin, MD

  Private Practice Nantes

  PRINCIPAL INVESTIGATOR

• François Hentges, MD

  CHL Luxembourg

  PRINCIPAL INVESTIGATOR

• François Durand Perdriel, MD

  Private Practice Nantes

  PRINCIPAL INVESTIGATOR

• François Spirlet, MD

  CH de Dinant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 3, 2011
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

FR (6); BE (12); LU (1)