A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
Public ClinicalTrials.gov record NCT03496571. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).
Study identification
- NCT ID
- NCT03496571
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 65 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 17, 2018
- Primary completion
- Jun 23, 2019
- Completion
- Jun 23, 2019
- Last update posted
- Jan 18, 2024
2018 – 2019
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenician Centers for Research and Innovation | Phoenix | Arizona | 85021 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| UC Denver | Aurora | Colorado | 80045 | — |
| Riverside Clinical Research | Edgewater | Florida | 32132 | — |
| Advanced Research Institute | New Port Richey | Florida | 34653 | — |
| Northwestern | Chicago | Illinois | 60611 | — |
| Indiana University Health | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| National Institutes of Health | Bethesda | Maryland | 20892 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| University of Pennsylvania, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Care Access Research | Pottsville | Pennsylvania | 17901 | — |
| ClinSearch | Chattanooga | Tennessee | 37421 | — |
| Vanderbilt University | Nashville | Tennessee | 37212 | — |
| Avant Research Associates | Austin | Texas | 78704 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03496571, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 18, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03496571 live on ClinicalTrials.gov.