Benralizumab for Eosinophilic Gastritis (ANTI-IL5RA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03473977|
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Gastritis or Gastroenteritis||Biological: Benralizumab Biological: Placebo||Phase 2 Phase 3|
To assess the efficacy of repeat subcutaneous (SC) doses of benralizumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with EG Secondary Objectives: To assess changes in endoscopic score/histological features/blood and biopsy eosinophil counts/clinical symptoms/esophageal, gastric, and duodenal tissue transcriptome changes/ before and after treatment with benralizumab.
26 subjects are planned to be enrolled into the study at Cincinnati Children's Hospital Medical Center.
Qualifying Subjects will receive 3 monthly sub-coetaneous injections of benralizumab/Placebo, followed by an option six month Open Label Extension period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will receive 3 doses of drug or placebo. An optional OLE will also be available following the double blind period.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The study is double blind. Randomization will be performed by external investigational pharmacy staff, which the dispenser of the drug/placebo at CCHMC.|
|Official Title:||A Double-Blind, Placebo-controlled Clinical Trial to Evaluate Efficacy of Benralizumab in Subjects With Eosinophilic Gastritis|
|Actual Study Start Date :||March 30, 2018|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||March 30, 2022|
This Arm is a subcutaneous dose of 30 mg of Benralizumab
Monoclonal antibody originally developed for the treatment of asthma. It is directed against the alpha-chain of the interleukin-5 receptor (CD125). Either Benralizumab or Placebo will be injected in 3 monthly doses of 30 mg, to examine the decrease in blood and tissue eosinophil counts in subjects with Eosinophilic Gastritis. This will be followed by an optional OLE period.
Other Name: Fasenra
Placebo Comparator: Placebo
This Arm is a subcutaneous dose of 30 mg of Placebo
Placebo will be injected in 3 monthly doses of 30 mg, as a comparator to injection with Benralizumab to examine the decrease in blood and tissue eosinophil counts in subjects with Eosinophilic Gastritis.
- Induction of disease remission [ Time Frame: 3 years ]Will be defined by the percentage of patients that achieve histological remission in the stomach as defined by peak eosinophil counts less than 30/hpf. Comparison between drug vs placebo will be the primary measurement endpoint.
- changes in endoscopic features before and after treatment with benralizumab [ Time Frame: 3 years ]Change in endoscopic score from pre- to post-treatment with benralizumab or placebo as measured by standardized endoscopy scoring systems.
- changes in histologic features before and after treatment with benralizumab [ Time Frame: 3 years ]Change in histologic score from pre- to post-treatment with benralizumab or placebo as measured by standardized histology forms specific to the diseases of interest.
- changes in blood eosinophil counts before and after treatment with benralizumab [ Time Frame: 3 years ]Change in blood eosinophil count before and after treatment with benralizumab or placebo as measured by CBC with differential.
- evaluate esophageal, gastric, and duodenal tissue transcriptome changes following benralizumab treatment. [ Time Frame: 3 years ]Baseline predictors and changes in expression of genes as assessed by whole genome RNA sequencing
- changes in peak eosinophil counts in biopsies before and after treatment with benralizumab [ Time Frame: 3 years ]Change in peak eosinophil count in biopsies (esophageal, gastric, and/or duodenal, as applicable) pre- vs. post-treatment with benralizumab or placebo
- changes in clinical symptoms before and after treatment with benralizumab for EG [ Time Frame: 3 years ]Change in symptoms from pre- to post-treatment with benralizumab or placebo as measured by patient-reported outcome measures.
- changes in quality of life before and after treatment with benralizumab for adult EoE [ Time Frame: 3 years ]Quality of life for pediatric EoE measured by the EoE-Quality of Life Scale A (range 0-96, with 96 being the most impaired)
- Assessment of Adverse Events and Serious Adverse Events to determine safety and tolerability of Benralizumab in subjects with EG [ Time Frame: 3 years ]Incidence and rate of severity of Adverse Events and Serious Adverse Events
- Physical exam to evaluate the safety and tolerability of Benralizumab in subjects with EG [ Time Frame: 3 years ]incidence of clinically significant findings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473977
|Contact: Cristin MurrayPetzold, BS||5138039079||Cristin.MurrayPetzold@cchmc.org|
|Contact: Lauren DiTommaso, BS||5138035446||lauren.DiTommaso@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Marc E Rothenberg, MD, PhD||Children's Hospital Medical Center, Cincinnati|