SUBLIVAC FIX Phleum Pratense DT/DRF

NCT01682070 | Completed Phase 2 DMC

• 1 other identifier: SP/0036
• Study Type: interventional
• Target: 266
• Locations: 2 countries
• Sites: 23

Brief Summary

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum pratense based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Phleum pratense compared to placebo.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

Sublingual immunotherapy; Dose range finding; Dose tolerability; grass pollen; Allergic rhinitis/rhinoconjunctivitis; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Nasal Provocation Test (NPT)

  5 months

• Number of related AEs

  First ten days of study medication intake

Secondary Outcomes (3)

• Serum specific immunoglobulin levels (IgE, IgG, IgG4)

  5 months

• Number of local and systemic reactions

  Duration of study medication intake (approximately 5 months)

• Peak Nasal Inspiratory Flow (PNIF)

  5 months

Study Arms (5)

SUBLIVAC FIX Phleum prat. 0 AUN/ml

PLACEBO COMPARATOR

Biological: Placebo

SUBLIVAC FIX Phleum prat. 3,333 AUN/ml

EXPERIMENTAL

Biological: SUBLIVAC FIX phleum prat.

SUBLIVAC FIX phleum prat. 10,000 AUN/ml

EXPERIMENTAL

Biological: SUBLIVAC FIX phleum prat.

SUBLIVAC FIX phleum prat. 20,000 AUN/ml

EXPERIMENTAL

Evaluation of the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml by an independent safety committee

Biological: SUBLIVAC FIX phleum prat.

SUBLIVAC FIX Phleum prat. 40,000 AUN/ml

EXPERIMENTAL

Start of SUBLIVAC FIX Phleum prat. 40,000 AUN/ml arm depends on safety in the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml arm evaluated by an independent safety committee

Biological: SUBLIVAC FIX phleum prat.

Interventions

SUBLIVAC FIX phleum prat. BIOLOGICAL

Comparison of different dosages to placebo

SUBLIVAC FIX Phleum prat. 3,333 AUN/ml; SUBLIVAC FIX Phleum prat. 40,000 AUN/ml; SUBLIVAC FIX phleum prat. 10,000 AUN/ml; SUBLIVAC FIX phleum prat. 20,000 AUN/ml

Placebo BIOLOGICAL

SUBLIVAC FIX Phleum prat. 0 AUN/ml

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Age ≥ 18 ≤ 60 years
• Allergic rhinitis/rhinoconjunctivitis related to grass pollen with or without concomitant mild to moderate persistent asthma
• FEV1 \> 70% for patients with a history of asthma, FEV \> 70% or PEF \> 80% for patients without a history of asthma
• A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for grass pollen assessed within 1 year before randomization.
• Positive serum specific anti-grass IgE-test (\> 0.7 U/mL)
• A positive TNPT for grass pollen at screening (Lebel score ≥ 6) at ≤10,000 AU/mL

You may not qualify if:

• Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than grass pollen
• Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets
• Completed immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years
• Completed unsuccessful specific immunotherapy in the past
• Vaccination within one week before start of therapy or during the initiation phase
• Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• Active malignancies or any malignant disease during the previous 5 years
• Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders
• Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study
• Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.)
• Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma)
• Use of systemic steroids within 4 weeks before start of the study and during the study
• Treatment with systemic and local β-blockers
• Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
• Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or -pill)

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (23)

CIMS Studienzentrum Bamberg

Bamberg, 96049, Germany

Location

Charité Universitaetsmedizin Berlin Klinik f. Dermatalogie, Venerologie u. Allergologie, Campus Charité Mitte

Berlin, 10117, Germany

Location

Klinik u. Poliklinik f. Dermatologie u. Allergologie Universität Bonn

Bonn, 53105, Germany

Location

Dermatologikum Hamburg - Dept. of Allergology

Hamburg, 20354, Germany

Location

HNO Praxis Dr. Horn/Dr. Zeuner

Heidelberg, 69120, Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

Hessen, 60590, Germany

Location

Dres.Ina Röhrig-Petering und Holger Petering

Hildesheim, 31134, Germany

Location

FÄ HNO Allergologie

Saalfeld, 07318, Germany

Location

Klinikum Stuttgart - Klinik f. Dermatologie u. Allergologie

Stuttgart, 70174, Germany

Location

Universitäts- Hautklinik Eberhard Karls - Universität Tübingen Department of Dermatology

Tübingen, 72076, Germany

Location

Dr. Med. Ulrich Neumann

Wolmirstedt, 393 26, Germany

Location

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, 15-430, Poland

Location

SP-ZOZ Ośrodek Zdrowia w Bieńkówce

Bieńkówka, PL-34 212, Poland

Location

NZOS "Zdrowie"

Cieszyn, 43-400, Poland

Location

Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40-952, Poland

Location

Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny im Norberta Barlickiego w Łodzi

Lodz, 90-153, Poland

Location

NZOZ Centrum Alergologii

Lodz, 90-553, Poland

Location

ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna

Lublin, 20-089, Poland

Location

NZOZ Centrum Alergologii

Lublin, 20-522, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

Location

ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

Tarnów, 33-100, Poland

Location

EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej

Wroclaw, 50-220, Poland

Location

NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

Wroclaw, 50-434, Poland

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Walter G. Canonica, Prof. Dr.

  Allergy and Respiratory Diseases University of Genoa

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 10, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

PL (12); DE (11)