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NCT03654976 · ClinicalTrials.gov registry record · Phase 3
Mite Asthma Pediatric Immunotherapy Trial
A Phase 3 study, sponsored by ALK-Abelló A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 533
- Enrollment target
NCT03654976: Completed Phase 3 study, sponsored by ALK-Abelló A/S.
NCT03654976 is a Phase 3 study that has completed, run by ALK-Abelló A/S. The registered enrollment target is 533 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654976, a Phase 3 study, has completed, sponsored by ALK-Abelló A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 533 participants
- Enrollment target
Study Summary
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.
Primary Outcome
The primary endpoint of the trial was the annualized rate of clinically relevant asthma exacerbations calculated as the number of exacerbations per year per participant during the efficacy evaluation period of 20 months. A clinically relevant asthma exacerbation had to be medically confirmed and was defined as asthma worsening leading to at least 1 of the following criteria: * Doubling of ICS dose compared to background treatment * Systemic corticosteroids for treatment of asthma symptoms for a
Interventions
- OTHER Placebo
- BIOLOGICAL HDM SLIT-tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 533 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 3 |
What the finished NCT03654976 record still lists
NCT03654976 is an interventional study that assigns participants to a tested intervention. The registered 533 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03654976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03654976 about?
NCT03654976 is a clinical study titled "Mite Asthma Pediatric Immunotherapy Trial". The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.
What is the current status of trial NCT03654976?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 533 participants. The study started on 2018-02-22. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT03654976?
The interventions under investigation include: Placebo (OTHER), HDM SLIT-tablet (BIOLOGICAL).
Who is sponsoring clinical trial NCT03654976?
This trial is sponsored by ALK-Abelló A/S, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03654976's enrollment target sits among peer trials
533 704th of 2000 higher than 1,297 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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