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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies

Primary Objective

The primary objective of the study is to evaluate the efficacy and safety of AK002 in patients with moderately to severely active EG and or/ED, with inadequate or loss of response to, or intolerance to standard therapies, when compared with placebo,

Study category: Digestive Health

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Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AK002 in patients with EG and/or EoD who have an inadequate response with, lost response to, or were intolerant to standard therapies. Patients enrolled in the study will receive 6 infusions of placebo or AK002 administered every 4 weeks and will be followed for 812 weeks after the last dose unless patients elect to enter the optional long-term extension study. Patients will be consented and then screened for 3–5 weeks (2118–35 days) prior to Day 1. Patients who meet all eligibility criteria can be enrolled into the study. Patients, who do not meet all eligibility criteria at screening or who qualify at screening but are not enrolled, may be assigned a new patient identification number and rescreened once. Patients rescreened within 30 days of signing the initial consent will not need to sign a new informed consent form (ICF) providing no changes have been made to the ICF.

Details
Age

Adult

Eligibility

Patients are eligible to enroll in the study if all of the following criteria are met: 1) Provide written informed consent. 2) Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry. 3) Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 5 hpf in the stomach and/or ≥30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD, without any other significant cause for the eosinophilia. Prior EGD may be used for eligibility as long as the EGD occurred within 30 days of the first screening visit for the AK002-016 study and was performed and centrally assessed as for the AK002-016 study. 4) Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening. 5) A weekly average score of abdominal pain, nausea, or diarrhea ≥3 on the PRO questionnaire (score from 0–10) and a weekly average TSS of ≥10 for at least 2 weeks of screening. 6) Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others. 7) If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study. 8) Willing and able to comply with all study procedures and visit schedule including follow-up visits.

Detailed Eligibility: Patients will be excluded from the study if they meet any of the following criteria: 1) Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit. 2) Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit. 3) Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit. 4) Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug. 5) Active Helicobacter pylori infection, unless treated and confirmed to be negative by repeat EGD prior to randomization and symptoms remain consistent. 6) History of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery. 7) History of bleeding disorders and/or esophageal varices. 8) Other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA). 9) Confirmed diagnosis of Hypereosinophilic Syndrome (HES). 10) Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 11) Presence of an abnormal laboratory value considered to be clinically significant by the Investigator. 12) Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk. 13) History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled. 14) Treatment for a clinically significant helminthic parasitic infection within 6 months of screening. 15) Positive helminthic infection on Ova and Parasite (O&P) test. 16) Seropositive for Strongyloides stercoralis at screening, except for patients with past but resolved infection. 17) Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening. 18) Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. 19) Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products). 20) Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant. 21) Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment. In general, study drug will be infused through a peripheral vein IV set. The IV line will be kept open before and after the infusion with sufficient quantities of 0.9% NaCl to assure patency. A volume of 100 mL* of the calculated dose of study drug will be infused over at least 4 hours on Study Day 1, over at least 3 hours on Study Day 29 (?3), and over at least 2 hours on Study Days 57 (?3), 85 (?3), 113 (?3), and 141 (?3). If the infusion is slowed or interrupted, the time may be extended longer than 4 hours, as long as it does not exceed 8 hours.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Paul Menard-Katcher

Paul Menard-Katcher

Study ID

Protocol Number: 19-3096

More information available at ClinicalTrials.gov: NCT04322604

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