Depigoid Birch 5000 Longterm Study in Adults and Adolescents

NCT01694836 | Completed Phase 3 DMC

• 2 other identifiers: 603-PG-PSC-1912012-000414-11
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 2

Brief Summary

Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula alba (Birch) - versus placebo.

Conditions

Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma; Sensitization Against Betula Alba (Birch) Pollen

Keywords

Allergic rhinitis; Allergic rhinoconjunctivitis; Allergy induced asthma; Birch (Betula alba); Hayfever; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Proof of efficacy (superiority vs. placebo) by means of the combined Symptom and Medication Score (SMS).

  For the primary outcome the SMS of nasal and ocular symptoms and their respective Rescue Medication score is used to assess efficacy of the perennial treatment regimen of Depigoid Birch 5000 DPP/mL versus placebo after 5 years (comprising 3 years of treatment plus 2 years treatment-free follow-up). An interim analysis will be conducted after 2 years. Data are captured via eDiary to be completed by the patients during each of the 5 pollen seasons within the duration of the study, starting prior to onset of pollen flight until after the end of the pollen seasons.

  after 5 years

Secondary Outcomes (11)

• Symptom score (SS) during the 1st, 3rd, and 4th pollen seasons.

  after 1 year, 2 years, 3 years, 4 years and 5 years

• Rescue Medication Score (RMS) during the 1st, 3rd, and 4th pollen season (futility and interim analyses).

  after 1 year, 2 years, 3 years, 4 years and 5 years

• combined Symptoms and Rescue Medication Score (SMS) during the 1st, 3rd, and 4th pollen season including pulmonary symptoms.

  after 1 year, 2 years, 3 years and 4 years

• Rhinitis Quality of Life Questionnaire (RQLQ) resp. RQLQ for adolescent patients (AdolRQLQ)

  Screening and after 1 year, 2 years, 3 years, 4 years and 5 years

• Immunology parameters (Total IgE, specific IgE, specific IgG1 and IgG4)

  Screening, after years 1, 2, 3 and 5 (resp. end of study)

Study Arms (2)

Depigoid Birch 5.000 DPP/ml

EXPERIMENTAL

Suspension for s.c. injection. Treatment schedule: 1. Build-up phase (1 day: 0,2 ml+0,3 ml at interval of 30 minutes) 2. Maintenance phase (3 years: 0,5 ml at intervals of 4-6 weeks)

Biological: s.c. injection

Placebo

PLACEBO COMPARATOR

Suspension for s.c. injection. Treatment schedule: 1. Build-up phase (1 day: 0,2 ml+0,3 ml at interval of 30 minutes) 2. Maintenance phase (3 years: 0,5 ml at intervals of 4-6 weeks)

Biological: s.c. injection

Interventions

s.c. injection BIOLOGICAL

3 years of therapy followed by 2 years (seasons) of treatment-free observational period

Also known as: Depigoid(R)Birch

Depigoid Birch 5.000 DPP/ml; Placebo

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of an appropriately signed and dated informed consent before any study specific examination,
• Clinical history of at least 2 years of seasonal allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma due to birch pollen allergy that has required repeated use of symptomatic treatment,
• Patients must have a minimum level of perception of symptoms from previous seasons defined as at least a moderate symptom level (i.e. a score of 2 on the 4-point-Likert scale) in at least 2 symptom categories prior to randomization,
• Lung function ≥ 80% of the predicted normal value,
• IgE-mediated sensitization has to be verified by:
• suggestive medical history, and
• specific IgE reactivity to birch pollen (CAP-RAST ≥ 2), and
• a positive SPT to birch pollen at screening or within 1 months prior to the screening visit. An SPT is considered positive if it results in a wheal diameter of at least 3.0 mm
• Internet access so that patients can complete the eDiary daily via internet during all 5 pollen seasons covered by the study protocol.

You may not qualify if:

• History of significant clinical manifestations of allergy as a result of sensitization against co-allergies, particularly-but not limited to-grass or weed pollen and perennial allergens (e.g. house dust mites, cat or dog).
• History of anaphylactic reaction.
• Moderate or severe persistent asthma (GINA 3 or 4).
• Mild persistent asthma (GINA 2), according to the Global Initiative for Asthma Guidelines, necessitating treatment with inhaled glucocorticoids at a daily dose level of \> 400 µg budesonide dose equivalents.
• Lung function \< 80% of the predicted normal value (for PEF: highest result of 3 measurements).
• Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis.
• Chronic structural diseases of the affected organs (e.g. eye, nose, lung).
• History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
• Any disease that prohibits the use of adrenaline (e.g. hyperthyroidism).
• Atopic dermatitis with SCORAD \>30 in the past or at screening.
• Ongoing or past full courses of SIT against birch pollen within the last 5 years.
• Topical and systemic treatment with β-blockers.
• Concomitant treatment with substances interfering with the immune system beginning 1 week prior to start of treatment.
• Use of systemic corticosteroids within 3 months prior to Visit 1-1.
• Immunization with vaccines within 7 days prior to Visit 1-1.

Sponsors & Collaborators

• Leti Pharma GmbH: lead

Study Sites (2)

Hautarztpraxis

Berlin, 13057, Germany

Location

Klinik und Poliklinik für Dermatologie und Allergologie der Universität

Bonn, 53105, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Natalja Novak, Prof. Dr.

  Klinik für Dermatologie und Allergologie der Universität Bonn

  PRINCIPAL INVESTIGATOR

• Angelika Sager, Dr. med.

  Leti Pharma GmbH

  STUDY DIRECTOR

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: August 27, 2012
• First Posted: September 27, 2012
• Study Start: September 17, 2012
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

DE (2)