Phase 2 N=119 Randomized Quadruple-blind Treatment

OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Eosinophilic Esophagitis (EoE)

Bottom Line

View on ClinicalTrials.gov: NCT01642212 ↗

Enrolled (actual)

119

Serious AEs

1.1%

Results posted

Dec 2015

Primary outcome: Primary: Percent of Participants Who Were Histologic Responders — 2.6; 38.8 percent of participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral Budesonide Suspension (MB-9) (Drug); Placebo (Drug)
Age: Pediatric, Adult · 11+ yrs
Sex: All
Sponsor: Shire
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants Who Were Histologic Responders	2.6; 38.8	<0.0001 sig
PRIMARY Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation	-7.53; -14.27	0.0096 sig
SECONDARY Change From Baseline in The DSQ Score Over Time	-4.92; -7.41; -7.42; -10.33	0.2649
SECONDARY Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation	-6.35; -11.20	—
SECONDARY Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation	7.9; 46.9; 0; 30.6	0.0001 sig
SECONDARY Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation	44.7; 69.4; 39.5; 63.3	0.0206 sig
SECONDARY Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation	2.6; 26.5; 2.6; 20.4	0.0026 sig
SECONDARY Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation	-1.41; -23.75	<0.0001 sig
SECONDARY Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation	0.19; -3.58	<0.0001 sig
SECONDARY Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation	-30.06; -65.56; -17.34; -76.90; -1.90; -69.28	0.0002 sig
SECONDARY Change From Baseline in The Physician's Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation	-10.16; -28.61	0.0015 sig
SECONDARY Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation	0; 0; 2.6; 2.1; 13.2; 2.1	0.1170
SECONDARY Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation	10.5; 18.4; 23.7; 18.4; 15.8; 20.4	0.1947
SECONDARY Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation	86.8; 71.4; 68.4; 71.4; 71.1; 73.5	—
SECONDARY Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation	2.6; 10.2; 7.9; 10.2; 13.2; 6.1	—
SECONDARY Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation	71.1; 83.7	0.1600
SECONDARY Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation	28.9; 16.3	—
SECONDARY Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation	47.4; 67.3; 39.5; 65.3	0.0606
SECONDARY Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods	1.2; 0.7	0.7817
SECONDARY Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period	0.02; -0.08; 0.05; 0.02; 0.05; 0.06	0.1686
SECONDARY Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period	-2.52; -3.25; -2.97; -4.89; -3.08; -4.87	0.4835

Summary

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Eligibility Criteria

Inclusion Criteria

Males and Females, age 11-40
Histologic evidence of EoE
History of clinical symptoms of EoE including dysphagia
Willing to continue with dietary, environmental or medical therapy
Ability to read and understand english
Written Consent

Exclusion Criteria

Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
Use of immunomodulatory therapy
Current use of swallowed corticosteroids
Esophageal strictures,varices or upper GI bleed
Other current diseases of the GI tract
Current viral infection or immunodeficiency condition
Pregnancy
Hypersensitivity to budesonide
History of non compliance

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01642212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.