Safety of ToleroMune Ragweed to Treat Ragweed Allergy in Ragweed Allergic Subjects With Rhinoconjunctivitis

NCT00878774 | Completed Phase 2

• 1 other identifier: TR001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that 36 million Americans suffer from seasonal allergies and that ragweed is the primary cause of autumn allergies, 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy. The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Ragweed in subjects in subjects with a documented history of allergic rhinoconjunctivitis on exposure to ragweed pollen. The efficacy of ToleroMune Ragweed will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin Response and Conjunctival Provocation Test.

Conditions

Allergy

Keywords

Ragweed allergy; Immunotherapy; Rhinoconjunctivitis; Toleromune Ragweed

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of multiple intradermal injections of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis

  28 weeks

Secondary Outcomes (4)

• Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole ragweed allergen at PTC after ToleroMune Ragweed injection compared to placebo

  28 weeks

• Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole ragweed allergen at PTC after ToleroMune Ragweed injection compared to placebo

  28 weeks

• Mean change from baseline in CPT score at PTC after ToleroMune Ragweed injection compared to placebo

  28 weeks

• Mean change from baseline in concentration of ragweed specific IgE at PTC after ToleroMune Ragweed injection compared to placebo

  28 weeks

Study Arms (5)

Cohort 1

EXPERIMENTAL

ToleroMune Ragweed, subjects to receive either active or placebo comparator

Biological: ToleroMune Ragweed; Biological: Placebo

Cohort 2

EXPERIMENTAL

ToleroMune Ragweed or placebo comparator

Biological: ToleroMune Ragweed; Biological: Placebo

Cohort 3

EXPERIMENTAL

ToleroMune Ragweed or placebo comparator

Biological: ToleroMune Ragweed; Biological: Placebo

Cohort 4

EXPERIMENTAL

ToleroMune Ragweed or placebo comparator

Biological: ToleroMune Ragweed; Biological: Placebo

Cohort 5

EXPERIMENTAL

ToleroMune Ragweed or placebo comparator

Biological: ToleroMune Ragweed; Biological: Placebo

Interventions

ToleroMune Ragweed BIOLOGICAL

ToleroMune Ragweed dose 1x4 administrations 2 weeks apart

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo BIOLOGICAL

Placebo comparator, 1x4 administrations 2 weeks apart

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18-65 years
• A reliable, documented history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) on exposure to ragweed for at least 2 years
• Allergy to ragweed, defined by positive skin prick test at the Screening Visit
• LPSR to ragweed allergen 8 hours after intradermal injection of greater than 25mm diameter response
• Positive CPT to ragweed allergen with a score ≥4
• Willing and able to provide written informed consent
• Subjects who are normally active and otherwise judged to be in good health
• The subject must be willing and able to comply with the study requirements
• If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal

You may not qualify if:

• Subjects with an FEV1 \<80% of normal
• Subjects who suffer from other seasonal allergies, and cannot complete the clinical study outside the pollen season or are symptomatic for significant perennial rhinitis
• A history of anaphylaxis to ragweed allergen; subjects who have a history of severe drug allergy, angioedema or anaphylactic reactions to food
• Subjects with a history of asthma
• Subjects who have auto-immune or rheumatoid diseases
• Clinical history of immunodeficiency, including immunosuppressant therapy
• Subjects in whom tyrosine metabolism is disturbed
• Current diagnosis of chickenpox or measles or exposure in the last 3 weeks
• Active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex
• Have symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit
• Allergen immunotherapy during the last 5 years or ragweed immunotherapy ever.
• Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody
• Use of the therapies listed in Section 5.9.2 at any time during the study will make the subject ineligible for the study
• Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension)
• Subjects being treated with beta-blockers

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (1)

Centre de Recherche Appliqué en Allergie de Québec

Québec, Quebec, G1V 4M6, Canada

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jacques Hebert, MD

  Centre de Recherche Appliqué en Allergie de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 10, 2010

Record last verified: 2010-11

Locations

CA (1)