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Monoclonal Antibodies
Mepolizumab 300 mg for Eosinophilic Esophagitis
Phase 2
Waitlist Available
Led By Evan S Dellon, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3 months of treatment
Awards & highlights
Study Summary
This study is evaluating whether a drug may help treat a condition that affects the esophagus.
Eligible Conditions
- Eosinophilic Esophagitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 3 months of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 3 months of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Change in Dysphagia Score
Secondary outcome measures
Absolute Peak Eosinophil Count
Mean Change in Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
Mean Change in the Straumann Dysphagia Instrument (SDI) Score
+3 moreSide effects data
From 2019 Phase 3 trial • 108 Patients • NCT0283649615%
Upper respiratory tract infection
13%
Bronchitis
13%
Nasopharyngitis
13%
Headache
11%
Pain in extremity
9%
Urinary tract infection
9%
Rhinitis
9%
Diarrhoea
7%
Dizziness
7%
Myalgia
7%
Pruritus
7%
Alopecia
7%
Arthralgia
7%
Pyrexia
6%
Influenza like illness
6%
Influenza
6%
Dyspnoea
6%
Hypoaesthesia
6%
Back pain
6%
Nasal obstruction
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Paraesthesia
6%
Contusion
6%
Vomiting
6%
Nausea
6%
Constipation
6%
Fatigue
4%
Vaginal haemorrhage
4%
Rash
4%
Hyperhidrosis
4%
Tinnitus
4%
Palpitations
4%
Skin abrasion
4%
Sinusitis
4%
Respiratory tract infection
4%
Oral herpes
4%
Malaise
4%
Asthma
4%
Stomatitis
4%
Toothache
2%
Diverticulitis
2%
Septic shock
2%
Pneumonia
2%
Bursitis infective
2%
Gastroenteritis
2%
Hypertension
2%
Dehydration
2%
Cystitis
2%
Rhinorrhoea
2%
Erysipelas
2%
Liver abscess
2%
Tooth infection
2%
Faecaloma
2%
Arrhythmia
2%
Foot fracture
2%
Costochondritis
2%
Epistaxis
2%
Peripheral swelling
2%
Hypereosinophilic syndrome
2%
Respiratory failure
2%
Oropharyngeal pain
2%
Abdominal pain
2%
Abdominal pain upper
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mepolizumab 300 mg SC
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo, followed by Mepolizumab 100 mgExperimental Treatment2 Interventions
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Group II: Mepolizumab 300 mgExperimental Treatment1 Intervention
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab 300 mg
2017
Completed Phase 3
~180
Mepolizumab 100 mg
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,968 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,194 Patients Enrolled for Eosinophilic Esophagitis
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,622 Total Patients Enrolled
2 Trials studying Eosinophilic Esophagitis
94 Patients Enrolled for Eosinophilic Esophagitis
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,623 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
551 Patients Enrolled for Eosinophilic Esophagitis
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