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AllergyPhase 2NCT00878774

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

A Phase 2 study testing ToleroMune Ragweed in people with Allergy, run by Circassia Limited at 1 site in Canada.

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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Allergy
What is being tested?
ToleroMune Ragweed
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteCanada
Study dates
Apr 2009to Nov 2009
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit
  • Female subjects who are pregnant, lactating or planning a pregnancy during the study
  • Have any clinically relevant abnormalities detected on physical examination
  • 12-lead ECG or vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator
  • Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator
  • Significant history of alcohol or drug abuse
  • History of immunopathological disease
  • Positive test for hepatitis B, hepatitis C or HIV at screening
  • Have previously been randomised into this study
  • Planned travel outside the study area for a substantial portion of the study period
  • Have received treatment with an investigational drug within 6 months prior to study screening or have participated in a study with a new formulation of a marketed drug one month prior to study screening
  • Have any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de Recherche Appliqué en Allergie de Québec

    Québec, Quebec, G1V 4M6

Other trials in Canada

About this study

Official title: An Escalating, Multiple-dose Study in Ragweed Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Ragweed

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.

Read the detailed description

This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Ragweed 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 LPSR, EPSR, CPT and levels of ragweed specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.

Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) two weeks apart (14±2 days). Subjects who comply with the inclusion/exclusion criteria will be assigned to one of 5 dose groups. The first dose group will receive 4 administrations of ToleroMune Ragweed. Successive dose groups will increasing doses given as 4 administrations of ToleroMune Ragweed, provided the first administration of the previous dose was safe and well tolerated.

In Period 3, Post-treatment Challenge will take place 19-25 weeks after the first administration in the Treatment Period and will be timed to be outside the Ragweed season. However in the event that the Ragweed season lasts beyond 26th October 2009, the PTC will take place 22-28 weeks after the first administration in the Treatment Period. Assessments performed will be identical to those at the Baseline Challenge. Follow-up will be conducted 3-10 days after PTC.

Conditions
Allergy
Being tested
ToleroMune Ragweed, Placebo
Keywords
Ragweed allergy, Immunotherapy, Rhinoconjunctivitis, Toleromune Ragweed
Medical subject headings
Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToleroMune RagweedBiological

    ToleroMune Ragweed dose 1x4 administrations 2 weeks apart

  • PlaceboBiological

    Placebo comparator, 1x4 administrations 2 weeks apart

Study groups in NCT00878774
Study groupRoleWhat they receive
Cohort 1ExperimentalToleroMune Ragweed, subjects to receive either active or placebo comparator
Receives: Biological: ToleroMune Ragweed; Biological: Placebo
Cohort 2ExperimentalToleroMune Ragweed or placebo comparator
Receives: Biological: ToleroMune Ragweed; Biological: Placebo
Cohort 3ExperimentalToleroMune Ragweed or placebo comparator
Receives: Biological: ToleroMune Ragweed; Biological: Placebo
Cohort 4ExperimentalToleroMune Ragweed or placebo comparator
Receives: Biological: ToleroMune Ragweed; Biological: Placebo
Cohort 5ExperimentalToleroMune Ragweed or placebo comparator
Receives: Biological: ToleroMune Ragweed; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 28 weeks

Secondary outcomes (4)

  1. 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

    Measured: 28 weeks

  2. 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

    Measured: 28 weeks

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

    Measured: 28 weeks

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

    Measured: 28 weeks

Timeline

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

  1. First posted9 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionNov 2009
  4. Study completionNov 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00878774
Sponsor's protocol ID
TR001
Status last verified
Nov 2010
First submitted
8 Apr 2009
Last updated
10 Nov 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ToleroMune Ragweed in people with Allergy, run by Circassia Limited at 1 site in Canada.

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 9 inclusion and 27 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 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Safety and tolerability of multiple intradermal injections of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis (time frame: 28 weeks). 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 NCT00878774.

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 10 Nov 2010.

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