SUBLIVAC FIX Mite Mixture Dose Tolerability Study

NCT02345278 | Completed Phase 1 DMC

• 1 other identifier: SM/0044
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 10

Brief Summary

Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. The amount of administered allergen is crucial for both efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens. According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.

Conditions

House Dust Mite Allergy

Keywords

Immunotherapy; Allergic rhinitis/rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of SUBLIVAC FIX Mite mixture (assessed by number and severity of local and systemic reactions)

  Safety and tolerability of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of local and systemic reactions.

  1 month treatment

Secondary Outcomes (4)

• Adverse Events

  1 month treatment

• Clinical and laboratory parameters (Safety of different dosages of SUBLIVAC FIX Mite mixture)

  1 month treatment

• Changes in immunoglobulin levels ((IgE, IgG, IgG4)

  1 month

• Proportion of patients reaching maintenance dose within 10 days

  10 days

Study Arms (5)

Placebo

PLACEBO COMPARATOR

once daily sublingual administration for 1 month

Other: Placebo

SUBLIVAC FIX Mite mixture 10,000 AU/mL

ACTIVE COMPARATOR

once daily sublingual administration for 1 month

Drug: SUBLIVAC FIX Mite mixture

SUBLIVAC FIX Mite mixture 25,000 AU/mL

ACTIVE COMPARATOR

once daily sublingual administration for 1 month

Drug: SUBLIVAC FIX Mite mixture

SUBLIVAC FIX Mite mixture 50,000 AU/mL

ACTIVE COMPARATOR

once daily sublingual administration for 1 month

Drug: SUBLIVAC FIX Mite mixture

SUBLIVAC FIX Mite mixture 100,000 AU/mL

ACTIVE COMPARATOR

once daily sublingual administration for 1 month

Drug: SUBLIVAC FIX Mite mixture

Interventions

SUBLIVAC FIX Mite mixture DRUG

Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

SUBLIVAC FIX Mite mixture 10,000 AU/mL; SUBLIVAC FIX Mite mixture 100,000 AU/mL; SUBLIVAC FIX Mite mixture 25,000 AU/mL; SUBLIVAC FIX Mite mixture 50,000 AU/mL

Placebo OTHER

Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

Placebo

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Male or female patients, age ≥ 18 ≤ 60 years
• Patients with allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, with or without concomitant at least partly controlled asthma
• Positive SPT to HDM D. pter or D. far (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) at screening
• Allergen specific serum IgE (ssIgE) level in serum for HDM D. pter or D. far (\> 0.7 U/ml), assessed at screening

You may not qualify if:

• Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) who are expected to have clinically relevant symptoms during the treatment period
• Patients sensitized and symptomatic to pets who are regularly exposed to pets
• Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
• Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
• Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
• Any other vaccination one week before start of treatment and during the up-dosing phase
• Active inflammatory disease in the mouth (e.g periodontitis, oral mucosal lichen planus)
• Known hypersensitivity to any of the excipients (i.e. Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, Aminocaproic acid, Glycerol, Peppermint oil, Caramel Colorant) of SLIT solution
• Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• Active malignancies or any malignant disease in the last 5 years
• A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
• Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
• Use of systemic corticosteroids 4 weeks before start treatment
• Treatment with systemic or local beta-blockers
• Clinically significant chronic sinusitis or ocular infection

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (10)

Charite Universitatsmedizin Berlin, Allergiezentrum

Berlin, D-10117, Germany

Location

Praxis Dr.med.Elke Hippke

Berlin, D-13057, Germany

Location

HNO-Heilkunde Praxis

Chemnitz, D-09130, Germany

Location

HNO und Allergologie Praxis

Dresden, D-01139, Germany

Location

HNO-Praxis Dr. Uta Thieme

Duisburg, D-47051, Germany

Location

Universitatsklinikum Dusseldorf, Department Dermatology

Düsseldorf, D-40225, Germany

Location

HNO Praxis Gottingen

Göttingen, D-37073, Germany

Location

HNO Praxis am Neckar

Heidelberg, D-69120, Germany

Location

HNO Gemeinschaftspraxis

Heidelberg, D-69126, Germany

Location

Dr.med. Ulrich Neumann Praxis

Wolmirstedt, D-39326, Germany

Location

MeSH Terms

Conditions

Dust Mite Allergy; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Margitta Worm, Prof.Dr.med.

  Allergie-Centrum-Charité

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

DE (10)