A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber

NCT02481856 | Completed Phase 2

• 1 other identifier: TT-03
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Average total rhinoconjunctivitis symptom score

  The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber

  After 24 weeks of treatment

Secondary Outcomes (6)

• Average total rhinoconjunctivitis symptom score

  After 8 and 16 weeks of treatment

• Average total rhinoconjunctivitis symptom score

  After 24 weeks of treatment

• Adverse events

  During the 24-weeks treatment period

• Vital signs

  During the 24-weeks treatment period

• Lung function measures

  During the 24-weeks treatment period

Study Arms (4)

12 DU SQ tree SLIT-tablet

EXPERIMENTAL

Betula verrucosa, allergen extract, Oral lyophilisate

Drug: SQ tree SLIT-tablet

7 DU SQ tree SLIT-tablet

EXPERIMENTAL

Betula verrucosa, allergen extract, Oral lyophilisate

Drug: SQ tree SLIT-tablet

2 DU SQ tree SLIT-tablet

EXPERIMENTAL

Betula verrucosa, allergen extract, Oral lyophilisate

Drug: SQ tree SLIT-tablet

Placebo

PLACEBO COMPARATOR

No active ingredient, Oral lyophilisate

Drug: Placebo

Interventions

SQ tree SLIT-tablet DRUG

12 DU SQ tree SLIT-tablet; 2 DU SQ tree SLIT-tablet; 7 DU SQ tree SLIT-tablet

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained before any trial related procedures are performed
• Male or female aged 18 to 65 years
• Female subjects of child-bearing potential must have a negative urine pregnancy test and be willing to practise contraceptive methods
• History of moderate-to-severe rhinoconjunctivitis induced by pollens from the birch group with or without asthma despite having received treatment with symptom relieving medication during the previous 2 tree pollen seasons
• Positive SPT response (wheal diameter ≥ 3 mm) to Betula verrucosa
• Positive specific IgE against Bet v1 (≥ IgE Class 2; ≥0.70 kU/L)
• Willing and able to comply with the trial protocol
• Minimum level of rhinoconjunctivitis symptoms, defined as a TSS of at least 7 (of 18), at one timepoint during birch baseline EEC session.

You may not qualify if:

• Symptoms induced by interfering allergens that are expected to be present during the periods where the subject attends the EEC sessions
• Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed.
• Allergic symptoms induced by perennial allergens such as house dust mites, and moulds
• A clinical history of uncontrolled asthma within 3 months prior to screening
• Reduced lung function FEV1 (\< 70% of predicted value after adequate pharmacological treatment)
• Asthma requiring treatment with inhaled corticosteroid within the past 3 months prior to screening
• Previous treatment with any allergy immunotherapy product with tree pollen allergens or a cross-reacting allergen within the past 5 years
• Ongoing treatment with any allergy immunotherapy product
• Immunosuppressive treatment within 3 months prior to the screening visit
• Treatment with tricyclic antidepressants, catecholamine-O-methyltransferase inhibitors, mono amine oxidase inhibitors and beta-blockers
• Treatment with antidepressant medication with antihistaminic effect
• Treatment with antipsychotic medications with antihistaminic effect
• Treatment with anti-IgE drugs within 130 days/5 half-lives of the drug (which ever longest)
• Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
• Severe oral inflammation or oral wounds at randomisation

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• Inflamax Research Incorporated: collaborator

Study Sites (1)

Inflamax Research Inc.

Mississauga, Ontario, ON, L4W 1A4, Canada

Location

Related Publications (1)

• Biedermann T, Couroux P, Greve TM, Makela M. Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials. Allergy. 2021 Dec;76(12):3733-3742. doi: 10.1111/all.14882. Epub 2021 May 15.

  PMID: 33905129 DERIVED

Study Officials

• Peter Couroux, MD

  Inflamax Research Incorporated

  PRINCIPAL INVESTIGATOR

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: April 30, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

CA (1)