A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Biological: SLITone ULTRA HDM immunotherapy

• Registration Number: NCT01728298
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-19
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• Aged 18 or older
• Moderate to severe persistent HDM allergic rhinitis with or without asthma
• Moderate to severe HDM allergic rhinitis symptoms during a baseline period
• Positive skin prick test response (wheal diameter ≥ 3 mm)
• Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)

Exclusion Criteria

• Previous treatment with immunotherapy with House dust mite immunotherapy
• Ongoing treatment with any allergen specific immunotherapy product
• Reduced lung function
• Clinical history of uncontrolled asthma
• Inflammatory conditions in the oral cavity with severe symptoms
• History of anaphylaxis with cardiorespiratory symptoms
• History of recurrent generalised urticaria
• A history of drug induced facial angioedema or hereditary angiooedema
• Any clinically relevant chronic disease (≥3 months duration)
• Systemic disease affecting the immune system
• Immunosuppressive treatment
• Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLITone ULTRA medium dose	SLITone ULTRA HDM immunotherapy	SLITone ULTRA HDM immunotherapy
SLITone ULTRA high dose	SLITone ULTRA HDM immunotherapy	SLITone ULTRA HDM immunotherapy
SLITone ULTRA low dose	SLITone ULTRA HDM immunotherapy	SLITone ULTRA HDM immunotherapy

Primary Outcome Measures

Name	Time	Method
Change from baseline in IgE-blocking factor after 6 months of treatment	6 months

Secondary Outcome Measures

Name	Time	Method
Number of subjects with treatment related adverse events	6 months

Trial Locations

Locations (1)

Proffesor Alain Didier; 🇫🇷 Toulouse, France