A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy
SUMMIT
1 other identifier
interventional
219
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 2, 2012
CompletedFirst Posted
Study publicly available on registry
November 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 22, 2014
January 1, 2014
9 months
November 2, 2012
January 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in IgE-blocking factor after 6 months of treatment
6 months
Secondary Outcomes (1)
Number of subjects with treatment related adverse events
6 months
Study Arms (3)
SLITone ULTRA low dose
ACTIVE COMPARATORSLITone ULTRA HDM immunotherapy
SLITone ULTRA medium dose
ACTIVE COMPARATORSLITone ULTRA HDM immunotherapy
SLITone ULTRA high dose
ACTIVE COMPARATORSLITone ULTRA HDM immunotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
Study Sites (1)
Proffesor Alain Didier
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Didier, Pr.
Hôpital Larrey, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2012
First Posted
November 19, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 22, 2014
Record last verified: 2014-01