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

NCT01490411 | Completed Phase 2 DMC

• 2 other identifiers: AL0903rBP2IX09001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

Specific immunotherapy; SIT; SCIT; recombinant

Outcome Measures

Primary Outcomes (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.

  6 hours

Secondary Outcomes (2)

• 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).

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

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

  3-12 month

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo 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.

Drug: Placebo

20 µg rBet v1-FV Immunotherapy

EXPERIMENTAL

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.

Biological: rBet v1-FV

80 µg rBet v1-FV Immunotherapy

EXPERIMENTAL

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.

Biological: rBet v1-FV

160 µg rBet v1-FV Immunotherapy

EXPERIMENTAL

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.

Biological: rBet v1-FV

320 µg rBet v1-FV Immunotherapy

EXPERIMENTAL

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.

Biological: rBet v1-FV

Interventions

Placebo DRUG

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.

Also known as: Comparator

Placebo

rBet v1-FV BIOLOGICAL

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.

Also known as: Specific Immunotherapy

20 µg rBet v1-FV Immunotherapy

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Allergopharma GmbH & Co. KG: lead

Study Sites (1)

Allergopharma GmbH & Co. KG

Hamburg, Reinbek, 21465, Germany

Location

Related Publications (1)

• 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.

  PMID: 23621350 RESULT

Study Officials

• Deepen Patel, MD, CCFP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: December 13, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

DE (1)