To evaluate the efficacy of AK002 in adult and adolescent patients with active EoE when compared to placebo, efficacy endpoints will be co-primary: 1) The proportion of patients who achieve a peak esophageal intraepithelial count of ≤6 eosinophils/hpf at Day 169 (Week 24). 2) Mean absolute change in Dysphagia Symptom Questionnaire (DSQ) score from Baseline to Weeks 23?24.
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and clinical benefit of AK002 in adult and adolescent patients with active and biopsy-proven EoE. Patients enrolled in the study will receive 6 infusions of placebo or AK002 administered every 4 weeks and will be followed for 8 weeks after the last dose. Subjects who complete the randomized, double-blind, placebo-controlled treatment (all 6 doses of placebo or AK002) and the Day 169 visit may have the option to receive 6 doses of open-label AK002 through participation in the OLE Period of the study.More
1) Male or female aged ≥12 and ≤80 years at the time of signing the ICF. 2) Confirmed diagnosis of EoE and intraepithelial eosinophilic infiltration of ≥15 eosinophils/hpf in 1 hpf from a biopsy collected during the Screening EGD without any other cause for the esophageal eosinophilia. 3) A biweekly average DSQ score of ≥12 from the last 2 weeks of Screening (the 2 weeks prior to the first dose). 4) History (by patient report) of an average of ≥2 episodes of dysphagia with intake of solid foods per week during the 4 weeks prior to Screening. 5) Subjects must have failed or not be adequately controlled on standard of care treatments for EoE symptoms, which could include PPI, systemic or topical corticosteroids, and/or diet, among others. 6) If on an allowed treatment for EoE (per Section 8.2), stable dose for at least 4 weeks prior to Screening and willingness to continue that dose for the study duration. 7) If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible. 8) Able and willing to comply with all study procedures.
Detailed Eligibility: Criteria Subjects will be excluded if they meet any of the following criteria: 1) Concomitant moderately or severely symptomatic EG and/or EoD*, defined as: – ≥30 eosinophils/hpf in 5 hpf in the stomach (EG) and/or ≥30 eosinophils/hpf in 3 hpf in the duodenum (EoD) without any other cause for eosinophilia as determined by central histology assessment of biopsies collected during the Screening EGD and – EG/EoD PRO Questionnaire weekly average single symptom score of ≥3 during the last 2 weeks of Screening for 1 of the following symptoms: abdominal pain, nausea, and/or diarrhea. * This exclusion criterion is only applicable to sites actively enrolling patients in the AK002-016 study. If a site is not actively screening and enrolling patients in the AK002-016 study, then this exclusion criterion is not applicable. 2) Causes of esophageal eosinophilia other than EoE or one the following: hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, or peripheral blood absolute eosinophil count of >1500 eosinophils/μL. 3) History of inflammatory bowel disease, celiac disease, achalasia, and/or esophageal surgery. 4) Any esophageal stricture unable to be passed with a standard diagnostic 9 mm to 10 mm upper endoscope or any critical esophageal stricture that requires dilation during screening. 5) History of bleeding disorders or esophageal varices. 6) 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 (with the exception of breast cancer). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy. 7) Active Helicobacter pylori infection (as determined by central histology staining of the biopsy collected during the Screening EGD), unless treated and confirmed to be negative prior to randomization and symptoms remain consistent. 8) Positive Ova and Parasite test at Screening, seropositive for Strongyloides stercoralis at Screening, and/or treatment for a clinically significant helminthic parasitic infection within 6 months of Screening. 9) Seropositive for HIV or hepatitis at Screening, except for vaccinated patients or patients with a history of hepatitis that has since resolved. 10) Prior exposure to AK002 or hypersensitivity to any constituent of AK002. 11) Change in dose of inhaled corticosteroids, nasal corticosteroids, PPI, and/or diet therapy within 4 weeks prior to Screening. 12) Use of oral corticosteroids (swallowed topical or systemic corticosteroids) within 8 weeks prior to Screening. 13) Use of any biologics or medications that may interfere with the study, such as immunosuppressive or immunomodulatory drugs including azathioprine, JAK inhibitors, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-4 receptor, e.g., dupilumab), anti-IL-5 (e.g., mepolizumab), anti-IL-5 receptor (e.g., benralizumab), anti-IL-13 (e.g., lebrikizumab), anti-IgE (e.g., omalizumab), within 12 weeks prior to Screening. 14) Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug or 90 days or 5 half-lives, whichever is longer, for biologic products. 15) Vaccination with live attenuated vaccines ≤30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected ≤5 half-lives (≤4 months) following study drug administration. 16) Treatment with chemotherapy or radiotherapy in the preceding 6 months. 17) Presence of abnormal laboratory values considered by the Investigator to be clinically significant.
II/III - A combination of phases: (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. and (3) 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.
University of Colorado Hospital
Protocol Number: 19-3097
More information available at ClinicalTrials.gov: NCT04322708
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