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

NCT02156791 | Completed Phase 2 DMC

• 1 other identifier: BTT-gpASIT007
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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 rhinoconjunctivitis, and to determine the maximal tolerated dose of gpASIT+TM .

Conditions

Hay Fever

Keywords

Seasonal allergic rhinoconjunctivitis; Grass pollen; Allergen specific immunotherapy

Outcome Measures

Primary Outcomes (1)

• (Serious) adverse events

  Up to 6 weeks

Secondary Outcomes (6)

• Grass pollen allergen -specific immunoglobulins

  up to 6 weeks

• Blocking antibody production

  up to 6 weeks

• Change from baseline in Conjunctival Provocation Test score

  at screening, after 4 weeks and 6 weeks of treatment

• Local reaction at the injection site

  up to 6 weeks

• Systemic reaction after injection

  up to 6 weeks

Study Arms (1)

gpASIT+TM

EXPERIMENTAL

Biological: gpASIT+TM

Interventions

gpASIT+TM BIOLOGICAL

gpASIT+TM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BioTech Tools S.A.: lead

Study Sites (1)

Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Officials

• Bettina Hauswald, MD

  Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 5, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 6, 2014

Record last verified: 2014-05

Locations

DE (1)