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Corticosteroid

Budesonide oral suspension for Eosinophilic Esophagitis

Phase 3
Waitlist Available
Research Sponsored by Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, eos (up to month 53)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the long-term safety of an oral suspension of budesonide in adolescents and adults with eosinophilic esophagitis.

Eligible Conditions
  • Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, eos (up to month 53)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, eos (up to month 53) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in BMD For Adolescents Assessed by DXA Scan at EOS (Up to Month 53)
Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 24
Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 36
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Budesonide Oral SuspensionExperimental Treatment1 Intervention
Participants received 10 milliliters (mL) of budesonide oral suspension at a concentration of 0.2 milligram per milliliter (mg/mL), twice daily, for up to 4 years 5 months.

Find a Location

Who is running the clinical trial?

ShireLead Sponsor
456 Previous Clinical Trials
95,897 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
712 Patients Enrolled for Eosinophilic Esophagitis
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,640 Total Patients Enrolled
Study DirectorStudy DirectorShire
1,275 Previous Clinical Trials
499,052 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
712 Patients Enrolled for Eosinophilic Esophagitis
~16 spots leftby Nov 2025
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