Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen

NCT01728519 | Terminated Phase 1

• 1 other identifier: AN003
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen

Conditions

Allergic Rhinitis; Allergy

Keywords

Allergy; Birch Pollen; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)

  84 days

Secondary Outcomes (2)

• change from baseline in blood levels of specific IgG4 and IgE

  after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months

• change from baseline in nasal provocation tests

  84 days

Other Outcomes (1)

• Total score of the Mini-RQLQ Quality-of-life questionnaire

  4 weeks during April 2009

Study Arms (4)

AllerT SC

EXPERIMENTAL

AllerT subcutaneous injections

Drug: AllerT SC

Placebo SC

PLACEBO COMPARATOR

placebo subcutaneous injections

Drug: Placebo SC

AllerT ID

EXPERIMENTAL

AllerT intra-dermal injections

Drug: AllerT ID

Placebo ID

PLACEBO COMPARATOR

placebo intra-dermal injections

Drug: Placebo ID

Interventions

AllerT SC DRUG

AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)

Also known as: AllerT subcutaneous injections

AllerT SC

AllerT ID DRUG

AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)

Also known as: Aller T intra-dermal injections

AllerT ID

Placebo SC DRUG

Placebo subcutaneous injections on days 1, 7, 14, 21 and 56

Also known as: Placebo subcutaneous injections

Placebo SC

Placebo ID DRUG

Placebo intra-dermal injections on days 1, 7, 14, 21 and 56

Also known as: Placebo intra-dermal

Placebo ID

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I minimum)
• Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT

You may not qualify if:

• received immunotherapy against any allergen within 3 years before the start of the study.
• symptomatic to perennial allergens or active seasonal allergy during the trial.
• non controlled asthma (peak flow lower than 30% of predicted value).
• history of any severe medical condition able to influence the course of the study
• Any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia.
• Subjects under immunosuppressive medication.
• Pregnant or lactating women or women willing or intending to become pregnant during the study.
• Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study

Sponsors & Collaborators

• Anergis: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, 1005, Switzerland

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Francois Spertini, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 20, 2012
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2012
• Last Updated: November 20, 2012

Record last verified: 2012-11

Locations

CH (1)