2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma

NCT01353755 | Completed Phase 3

• 2 other identifiers: AL0906rP2009-011504-36
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.

Conditions

Rhinoconjunctivitis; Allergic Asthma

Keywords

specific immunotherapy; SIT

Outcome Measures

Primary Outcomes (1)

• Rhinoconjunctivitis Symptom-Medication-Score

  Change of the AUC of the RC-SMS from the baseline season to the season after 2 years of treatment

  2 years

Secondary Outcomes (1)

• adverse events

  entire trial

Study Arms (2)

recombinant Phleum (rPhleum) allergen cocktail

EXPERIMENTAL

The recombinant Phleum (rPhleum) allergen cocktail is prepared by mixing equivalent volumes of each single allergen adsorbate. The recombinant Phleum (rPhleum) allergen cocktail contains Phleum pratense (Phl p) allergens: Type 1, 2, 5 and 6 at equimolar quatities. The total protein concentration in the highest strength is 200μg protein per 1mL aluminium hydroxide suspension.

Drug: Grass pollen specific immunotherapy

Placebo

PLACEBO COMPARATOR

Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.

Drug: Placabo

Interventions

Grass pollen specific immunotherapy DRUG

* Strength 1 (0.78μg/mL) * Strength 2 (6.25μg/mL) * Strength 3 (50μg/mL) * Strength 4 (200μg/mL) The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo.

recombinant Phleum (rPhleum) allergen cocktail

Placabo DRUG

Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the subject given informed consent according to local requirements before any trial-related activities?
• Is the subject a legally competent male or female outpatient?
• Is the subject aged 12 - 65 year?
• Does the subject suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by
• skin prick test wheal for grass pollen ≥ 5mm in diameter and
• histamine (1,0% histamindihydrochloride ) wheal ≥ 3mm and
• NaCl control reaction \< 3mm and
• EAST result (inhouse Allergopharma) ≥ 1.5kU/L to grass pollens and
• proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and
• main discomfort in the respective months.
• Does the subject with bronchial asthma at entry have a confirmed diagnosis of asthma and does his asthma has been classified as "controlled" according to GINA guidelines (version 2006) with PEF or FEV1at least 80% of predicted normal?

You may not qualify if:

• For female patients: Does the subject use effective contraception and does she have a negative pregnancy test result? (Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectibles, combined or oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. No pharmacological interactions are known for hormonal contraceptives and specific immunotherapeutic preparations.)
• Does the subject suffer from rhinoconjunctivitis symptoms documented in the subjects diary during the baseline season?
• Does the subject have demonstrated a symptom-score of at least 4 per day during the week following the peak pollen count in the baseline season?
• Is the subject unable to understand and comply with the requirements of the trial, as judged by the investigator?
• Is/was the subject involved in the planning and conduct of the trial?
• Is the subject an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites?
• Is the subject in any relationship of dependence with the sponsor and/or with the investigator?
• Has the subject been previously enrolled or randomised to treatment in the present trial?
• Is the subject mentally disabled?
• Is the subject institutionalised due to an official or judicial order?
• Does the subject have a positive pregnancy test before the baseline phase?
• Does the subject use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator?
• Is the subject pregnant or within the lactation period?
• Is the subject seeking to become pregnant?
• Has the subject undergone previous specific immunotherapy with grass pollen allergens in any formulation?

Sponsors & Collaborators

• Allergopharma GmbH & Co. KG: lead

Study Sites (1)

Allergopharma GmbH & Co. KG

Hamburg, Reinbek, 21465, Germany

Location

Related Links

• Click here for information about this trial in the European Clinical Trials Register

Study Officials

• Nicolas Hunzelmann, Prof. Dr.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: May 13, 2011
• First Posted: May 16, 2011
• Study Start: October 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

DE (1)