SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

NCT01639768 | Completed Phase 2 DMC

• 1 other identifier: SB/0038
• Study Type: interventional
• Target: 270
• Locations: 3 countries
• Sites: 20

Brief Summary

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

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

Sublingual immunotherapy; Dose range finding; Dose tolerability; Birch 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 Birch 0 AUN/ml

PLACEBO COMPARATOR

Drug: SUBLIVAC FIX Birch

SUBLIVAC FIX Birch 3,333 AUN/ml

ACTIVE COMPARATOR

Drug: SUBLIVAC FIX Birch

SUBLIVAC FIX Birch 10,000 AUN/ml

ACTIVE COMPARATOR

Drug: SUBLIVAC FIX Birch

SUBLIVAC FIX Birch 20,000 AUN/ml

ACTIVE COMPARATOR

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

Drug: SUBLIVAC FIX Birch

SUBLIVAC FIX Birch 40,000 AUN/ml

ACTIVE COMPARATOR

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

Drug: SUBLIVAC FIX Birch

Interventions

SUBLIVAC FIX Birch DRUG

Comparison of different dosages to placebo

SUBLIVAC FIX Birch 0 AUN/ml; SUBLIVAC FIX Birch 10,000 AUN/ml; SUBLIVAC FIX Birch 20,000 AUN/ml; SUBLIVAC FIX Birch 3,333 AUN/ml; SUBLIVAC FIX Birch 40,000 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 birch 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 birch pollen assessed within
• year before randomization.
• Positive serum specific anti-birch IgE-test (\> 0.7 U/mL)
• A positive TNPT for birch pollen at screening (Lebel score ≥ 6) at
• ,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 birch 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 birch 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 (20)

AKI, spol s. r.o.

Brno, 639 00, Czechia

Location

Ordinace Alergologie

Most, 434 01, Czechia

Location

Respiral s. r.o.

Pilsen, 301 00, Czechia

Location

Ústav imunologie a alergologie

Pilsen, 304 60, Czechia

Location

Kasmed s. r.o.

Tábor, 390 01, Czechia

Location

Praxis für Atemwegserkrankungen

Leipzig, Saxony, 04275, Germany

Location

Medizinische Fakultät. Klinik und Poliklinik für HNO-Klinik

Dresden, 01062, Germany

Location

HNO-Wiesbaden - Center for Rhinology and Allergology

Wiesbaden, 65183, Germany

Location

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, 15-430, 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

Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"

Krakow, 31-023, Poland

Location

Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny Nr.1 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

Related Publications (1)

• Pfaar O, van Twuijver E, Boot JD, Opstelten DJ, Klimek L, van Ree R, Diamant Z, Kuna P, Panzner P. A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis: results of a phase II study. Allergy. 2016 Jan;71(1):99-107. doi: 10.1111/all.12760. Epub 2015 Oct 26.

  PMID: 26417901 DERIVED

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

• Oliver Pfaar, PD. Dr. med.

  Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

PL (12); CZ (5); DE (3)