search
Back to results

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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
SLITone ULTRA HDM immunotherapy
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring House Dust Mite, allergy, rhinitis, asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Proffesor Alain Didier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

SLITone ULTRA low dose

SLITone ULTRA medium dose

SLITone ULTRA high dose

Arm Description

SLITone ULTRA HDM immunotherapy

SLITone ULTRA HDM immunotherapy

SLITone ULTRA HDM immunotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of subjects with treatment related adverse events

Full Information

First Posted
November 2, 2012
Last Updated
January 20, 2014
Sponsor
ALK-Abelló A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01728298
Brief Title
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy
Acronym
SUMMIT
Official Title
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
House Dust Mite, allergy, rhinitis, asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLITone ULTRA low dose
Arm Type
Active Comparator
Arm Description
SLITone ULTRA HDM immunotherapy
Arm Title
SLITone ULTRA medium dose
Arm Type
Active Comparator
Arm Description
SLITone ULTRA HDM immunotherapy
Arm Title
SLITone ULTRA high dose
Arm Type
Active Comparator
Arm Description
SLITone ULTRA HDM immunotherapy
Intervention Type
Biological
Intervention Name(s)
SLITone ULTRA HDM immunotherapy
Primary Outcome Measure Information:
Title
Change from baseline in IgE-blocking factor after 6 months of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of subjects with treatment related adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Didier, Pr.
Organizational Affiliation
Hôpital Larrey, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Proffesor Alain Didier
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy

We'll reach out to this number within 24 hrs