A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy

Allergic Rhinitis Clinical Trial

— SUMMIT  

Official title:

A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728298
• Other study ID #: SU-M-01
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2012
• Last updated: January 20, 2014
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Biological:
• SLITone ULTRA HDM immunotherapy

Locations

Country	Name	City	State
France	Proffesor Alain Didier	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in IgE-blocking factor after 6 months of treatment		6 months	No
Secondary	Number of subjects with treatment related adverse events		6 months	Yes