Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

NCT01144429 | Completed Phase 2 DMC

• 2 other identifiers: 603-PG-PSC-1732008-008448-26
• Study Type: interventional
• Target: 344
• Locations: 3 countries
• Sites: 39

Brief Summary

Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose. 4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. comparison between treatment arms of increased amount of quantities of allergen to provoke a positive CPT at the end of treatment.

Conditions

Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma; Immunotherapy, Allergen

Keywords

Allergic Rhinitis +- intermittent asthma; Allergic Rhinoconjunctivitis +- intermittent asthma; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Conjunctival Provocation Test

  Comparison between dosage groups of percentage of patients who need an increased amount of allergen to provoke a positive CPT at the end of the treatment (comparison of slope of efficacy) It is expected that at the end of the study higher doses are necessary to provoke a positive CPT. Acc. to the EMEA "Guideline on clinical development of products for specific immunotherapy for the treatment of allergic diseases" provocation tests are accepted as primary outcomes for dose-finding studies.

  At screening and after approx 22 weeks (EoS)

Secondary Outcomes (8)

• Laboratory parameters (immunology)

  At screening and after approx. 22 weeks (EoS)

• Conjunctival Provocation Test

  after approx. 22 weeks

• Laboratory (hematological, clinical chemistry, immunological) as a measure of safety

  At screening and after approx. 22 weeks (EoS)

• Overall assessment of safety (tolerability)at the end of the study

  after approx. 22 weeks (EoS)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  at 4-weekly intervals (retrospectively at study visits)

Study Arms (4)

100 DPP/mL

ACTIVE COMPARATOR

Concentration of solution fo s.c. injection: 100 DPP/mL

Biological: Allergoid, allergenic extract of 100% Birch

1000 DPP/mL

ACTIVE COMPARATOR

Concentration of solution fo s.c. injection: 1000 DPP/mL

Biological: Allergoid, allergenic extract of 100% Birch

5000 DPP/mL

ACTIVE COMPARATOR

Concentration of solution fo s.c. injection: 5000 DPP/mL

Biological: Allergoid, allergenic extract of 100% Birch

10000 DPP/mL

ACTIVE COMPARATOR

Concentration of solution fo s.c. injection: 10000 DPP/mL

Biological: Allergoid, allergenic extract of 100% Birch

Interventions

Allergoid, allergenic extract of 100% Birch BIOLOGICAL

Subcutaneous injections Build-up = 1 day: 0,1mL + 0,2mL + 0,2mL s.c. in intervals on 30 minutes; Maintenance = 5 x single injection of 0,5 mL s.c. every 4 weeks

Also known as: Depigoid (R), Depigmented, glutaraldehyd-polymerized allergenic extract of

100 DPP/mL; 1000 DPP/mL; 10000 DPP/mL; 5000 DPP/mL

Eligibility Criteria

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

You may qualify if:

• Patients have provided an appropriately signed and dated informed consent prior to any study specific examination,
• Patients must be ≥ 18 and ≤ 70 years of age at Visit 1,
• Patients must have a perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS),
• Patients must have an FEV1 or PEF value \> 80% of the predicted normal value (for PEF: highest result of 3 measurements),
• Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against birch pollen,
• IgE-mediated sensitization has to be verified by:
• suggestive medical history, and
• specific IgE against birch pollen (CAP-Rast ≥ 2), and
• a positive SPT to birch pollen (the SPT is considered positive if it results in a wheal diameter of at least 3 mm and at least the size of histamine reference), and
• a positive CPT with a birch pollen concentration of up to 10,000 SQ-units/mL.
• Special criteria for patients with co-allergies
• Patients do not suffer from typical symptoms against co-allergens,
• Specific CAP-RAST against co-allergens \< CAP-RAST against birch pollen (the difference has to be ≥ 2), patients with co-allergens against animal dander can be randomized even if the CAP RAST difference is \< 2, but must not be exposed to the specific allergen,
• Result of SPT against co-allergens \< result of SPT against birch pollen.

You may not qualify if:

• Acute and chronic conjunctivitis,
• Infectious conjunctivitis,
• History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites),
• Symptoms due to co-allergies,
• Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines,
• Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis,
• Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis),
• Diseases of the immune system including autoimmune and immune deficiencies,
• Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism),
• Severe uncontrolled diseases that could increase the risk for the patients participating in the study, which include but are not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or hematological disorders,
• Any malignant disease during the previous 5 years,
• Any significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk for the study patient,
• Alcohol, drug, or medication abuse within the past year,
• Severe psychiatric, psychological, or neurological disorders,
• Use of immunotherapy against birch pollen within the last 5 years,

Sponsors & Collaborators

• Leti Pharma GmbH: lead
• Laboratorios LETI SL (Study Medication): collaborator
• Pierrel Research Europe GmbH: collaborator
• Labor Dr. Spranger (Central lab): collaborator

Study Sites (39)

Dermatology Weber

Augsburg, 86163, Germany

Location

Licca Klinik Dermatologie

Augsburg, 86179, Germany

Location

Allergie-Centrum-Charité

Berlin, 10117, Germany

Location

Klinische Froschung Berlin Mitte

Berlin, 10117, Germany

Location

Hippke, Ear-Nose-Throat Specialist and Allergy

Berlin, 13057, Germany

Location

Universität Bonn, Klinik und Poliklinik für Dermatologie

Bonn, 53127, Germany

Location

Klinikum Carl-Gustav Carus, Klinik+Poliklinik für HNO

Dresden, 01307, Germany

Location

Thieme, Ear-Nose-Throat Specialist and Allergology

Duisburg, 47051, Germany

Location

Dominicus Hautzentrum

Dülmen, 48249, Germany

Location

Spaeth, Ear-Nose-Throat Specialist and Allergy

Düren, 52351, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Clinical Research Hamburg GmbH

Hamburg, 22143, Germany

Location

Stefan, Dermatology and Allergy

Hennef (Sieg), 53773, Germany

Location

Feussner, Pulmology and Allergology

Kassel, 34121, Germany

Location

Tagesklinik für Allergie und Hautkrankheiten Brüning

Kiel, 24148, Germany

Location

Zentrum für Therapiestudien der Innomed Leipzig GmbH

Leipzig, 04103, Germany

Location

Medamed GmbH Studienambulanz

Leipzig, 04109, Germany

Location

Amann, Ear-Nose-Throat Specialist and Allergy

Lingen, 49809, Germany

Location

CRC Universitätsklinikum Mainz

Mainz, 55131, Germany

Location

Universität, Klinik und Poliklinik für Hautkrankheiten

Münster, 48149, Germany

Location

Ear-Nose-Throat Specialist Schaefer

Pirna, 01796, Germany

Location

Palm, Ear-Nose-Throat, Allergology

Röthenbach, 90552, Germany

Location

Steinborn Dermatology

Straubing, 94315, Germany

Location

Zentrum für Rhinologie und Allergie

Wiesbaden, 65183, Germany

Location

Hautarztpraxis Allergie Hoffmann

Witten, 58453, Germany

Location

Kaunas Distric Hospital

Kaunas, 45130, Lithuania

Location

Kaunas Medical University Clinics

Kaunas, 50009, Lithuania

Location

ENT Clinic "Trirema Medica"

Vilnius, 1113, Lithuania

Location

Zakład Alergologii, SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31531, Poland

Location

Klinika Pulmonologii i Alergologii, SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. N. Barlickiego UM w Łodzi

Lodz, 90153, Poland

Location

NZOZ Centrum Alergologii

Lodz, 90553, Poland

Location

CSK UM w Łodzi, Klinika Immunologii, Reumatologii i Alergii, Zakład Immunologii Klinicznej

Lodz, 92213, Poland

Location

Centrum Alergologii

Poznan, 60214, Poland

Location

Alergologia Plus, Specjalistyczny NZOZ, Ośrodek Diagnostyki i Terapii Uczuleń

Poznan, 60693, Poland

Location

NZOZ Alergo-Med.

Poznan, 60823, Poland

Location

Alergo-Med. Specjalistyczna Przychodnia Lekarska Sp. z o. o.

Tarnów, 33100, Poland

Location

Poradnia Alergologiczna, Gabinet Lekarski

Tomaszów Mazowiecki, 97200, Poland

Location

NZOZ Almed Specjalistyczna Opieka Medyczna

Wroclaw, 50445, Poland

Location

NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

Wroclaw, 54239, Poland

Location

MeSH Terms

Interventions

Allergoids

Intervention Hierarchy (Ancestors)

Allergens; Antigens; Biological Factors

Study Officials

• Margitta Worm, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Angelika Sager, Dr.

  Leti Pharma GmbH, Witten, Germany

  STUDY CHAIR

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

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

LI (3); DE (25); PL (11)