A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy (SUMMIT)

January 20, 2014 updated by: ALK-Abelló A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Proffesor Alain Didier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SLITone ULTRA low dose
SLITone ULTRA HDM immunotherapy
Biological: SLITone ULTRA HDM immunotherapy
Active Comparator: SLITone ULTRA medium dose
SLITone ULTRA HDM immunotherapy
Biological: SLITone ULTRA HDM immunotherapy
Active Comparator: SLITone ULTRA high dose
SLITone ULTRA HDM immunotherapy
Biological: SLITone ULTRA HDM immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in IgE-blocking factor after 6 months of treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with treatment related adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Alain Didier, Pr., Hôpital Larrey, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-M-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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