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Allergic RhinoconjunctivitisPhase 2NCT01490411

Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis

A Phase 2 study testing rBet v1-FV in people with Allergic Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.

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

The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and also contains Aluminum Hydroxide but does not contain the experimental drug). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Allergic Rhinoconjunctivitis
What is being tested?
rBet v1-FV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteGermany
Study dates
Oct 2010to Sep 2011
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

  • Patients must meet all of the following to be eligible for enrollment:
  • Is a male or female, aged 18 to 65 years, inclusive.
  • Has a clinical history of allergic rhinitis to birch pollen at least during each of the last 2 years.
  • Has a birch pollen specific IgE result (EAST) greater than 0.75 kU/L on blood sample drawn at Visit 1.
  • Has a positive skin prick test to birch allergen(s) at Visit 1, with a wheal diameter of at least 4 mm.
  • Has minimum qualifying symptom scores at Visit 2.
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  • Patients with sensitization to cat epithelia, dog epithelia, Dermatophagoides farinae or Dermatophagoides pteronyssinus as per the skin prick test and/or EAST, may be included if sensitization is not clinically relevant.
  • Meets the concomitant medication restrictions described in the protocol.
  • Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.
  • Is willing and able to give signed informed consent, and must have provided this consent.
  • Is willing and able to attend required study visits.

Who cannot join

  • A patient will not be included in this study if any of the following criteria apply:
  • For female subjects:
  • Female subjects with childbearing potential (i.e., females are not chemically or surgically sterilised or females who are not post-menopausal) with a positive pregnancy test at Visit 1.
  • Female subjects with a negative pregnancy test at enrolment and not willing to use a reliable and highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly during the trial, as judged by the investigator.
  • Pregnancy and lactation.
  • Female subjects seeking to become pregnant.
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  • General criteria:
  • Individuals weighing less than 40 Kg.
  • Not able to understand and comply with the requirements of the trial, as judged by the investigator.
  • Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days.
  • Treatment with beta-blockers (locally and systemically).
  • Contraindication for adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension).
  • Immunotherapy criteria:
  • Previous specific immunotherapy with birch or other early blossoming trees (e.g. Alder, Hazel) in any formulation within the past 5 years.
  • Any current immunotherapy.
  • Any previous specific immunotherapy with unknown or mixed allergens.
  • Other allergies:
  • Clinically relevant perennial allergies.
  • Diseases and health status:
  • Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons.
  • Has diagnosed asthma.
  • Has PEF or FEV1 < 80% of predicted normal
  • Any acute or chronic disease that, in the opinion of the investigator, would affect the study objectives or subject safety (e.g., Diabetes mellitus type I, malignant neoplasia, chronic renal failure, inflammatory diseases of liver or kidneys, emphysema, bronchiectasis).
  • Autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], Grave's disease, Hashimoto's thyroiditis) at time of screening.
  • Has a history of other clinically significant diseases which might impact efficacy analysis.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Allergopharma GmbH & Co. KG

    Hamburg, Reinbek, 21465

Other trials in Germany

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With rBet v1-FV Compared to Placebo in Birch Pollen-Allergic Patients With IgE-Mediated Seasonal Allergic Rhinoconjunctivitis

The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a vaccine that works by exposing your immune system to something that resembles birch. This vaccine may help to lessen your allergy symptoms during the natural birch season.

Read the detailed description

Type I allergy is an immune-disorder which stems from the formation of IgE antibodies against proteins and glycoproteins from plants, insects, animals and fungi, most of which are normally considered harmless. The cross-linking of specific IgE antibodies on effector cells by allergens activates an immunological cascade leading to the symptoms of Type I allergy including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic Rhinitis is the most common chronic atopic disease and is associated with considerable cost and co-morbidity. Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses and weeds, is characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery, red eyes.

Recombinant preparations offer various advantages over those based on natural allergen extracts. Recombinant proteins can be produced in highly purified forms of pharmaceutical quality; proteins are molecularly defined thus ensuring product consistency and minimising problems related to allergen extract standardisation; preparations only include those proteins that are considered relevant for specific immunotherapy; the risk of contamination with other allergenic material is excluded; the whole production process can be designed to exclude any risk factors for the introduction of infectious agents; the relative dosages of individual components of a final preparation can be optimised to favour better clinical efficacy. Allergy vaccination (AV) mediates the immune response to allergen exposure by altering the TH2 response in favour of a TH1 T-cell response, increasing IgG production and decreasing the production of inflammatory cytokines. rBet v1-FV is an AV designed to enhance beneficial immune responses. The investigational product has demonstrated efficacy and good tolerability in one previous pivotal Phase III and two previous Phase II studies.

Being tested
Placebo, rBet v1-FV
Keywords
Specific immunotherapy, SIT, SCIT, recombinant

What participants receive

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

  • PlaceboDrug

    Also called Comparator

    The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.

  • rBet v1-FVBiological

    Also called Specific Immunotherapy

    The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.

  • rBet v1-FVBiological

    Also called Spicific Immunotherapy

    The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.

  • rBet v1-FVBiological

    Also called Specific Immunotherapy

    The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.

  • rBet v1-FVBiological

    Also called Spicific Immunotherapy

    The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.

Study groups in NCT01490411
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo was given the same way as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV.
Receives: Drug: Placebo
20 µg rBet v1-FV ImmunotherapyExperimentalThe drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
Receives: Biological: rBet v1-FV
80 µg rBet v1-FV ImmunotherapyExperimentalThe drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
Receives: Biological: rBet v1-FV
160 µg rBet v1-FV ImmunotherapyExperimentalThe drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
Receives: Biological: rBet v1-FV
320 µg rBet v1-FV ImmunotherapyExperimentalThe drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
Receives: Biological: rBet v1-FV

What is being measured

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

  1. Relative efficacy of four different doses compared to placebo.

    To assess the relative efficacy of four different dose regimes of rBet v1-FV compared to Placebo based on post-treatment intracutaneous testing results. The post-treatment wheal size (length in mm) after intracutaneous injection of a birch pollen solution was determined.

    Measured: 6 hours

Secondary outcomes (2)

  1. Relative efficacy of four different dose regimes of rBet v1-FV compared to Placebo and to each other in the reduction of symptoms of allergic rhinitis in the Environmental Exposure Chamber (EEC).

    To assess the relative efficacy of four different dose regimes of rBet v1-FV compared to Placebo and to each other in the reduction of symptoms of allergic rhinitis in the Environmental Exposure Chamber (EEC), based on the change from baseline in area under the curve (AUC) for Total Symptom Score (TSS), Total Nasal Symptom Score (TNSS), Total Non-Nasal Symptom Score (TNNSS) and Total Ocular Symptom Score (TOSS).

    Measured: 1, 2, 3, 4, 5, 6, 7 and 8.0 hour(s) in the EEC

  2. Relative safety and tolerability of four different dose regimes of rBet v1-FV compared to Placebo

    Recording of all adverse events, the vital signs and clinical laboratory tests.

    Measured: 3-12 month

Timeline

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

  1. First posted13 Dec 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2011
  4. Study completionSep 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490411
Sponsor's protocol ID
AL0903rB
Other IDs
P2IX09001
Status last verified
Jan 2014
First submitted
18 Nov 2011
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Meyer W, Narkus A, Salapatek AM, Hafner D. Double-blind, placebo-controlled, dose-ranging study of new recombinant hypoallergenic Bet v 1 in an environmental exposure chamber. Allergy. 2013 Jun;68(6):724-31. doi: 10.1111/all.12148. Epub 2013 Apr 27.

    PubMed 23621350

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rBet v1-FV in people with Allergic Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.

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 11 inclusion and 25 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 24 Jan 2014. 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 Germany. 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. Some participants in this study may receive a placebo. 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?

Relative efficacy of four different doses compared to placebo. (time frame: 6 hours). 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 NCT01490411, which also lists 1 linked publication.

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 24 Jan 2014.

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