EUCTR2019-004391-19-NL进行中（未招募）1 期
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safetyof AK002 in Adult and Adolescent Subjects with Active Eosinophilic Esophagitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Allakos Inc.
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria
- •Subjects with active EoE are eligible to enroll in the study if all of the following criteria are met:
- •1) Male or female aged =12 and =80 years at the time of signing 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) Baseline DSQ (biweekly mean DSQ) score of =12 from the last 2 weeks of Screening (the 14 days prior to the first dose). per the validated Algorithm in Appendix 11.
- •4) History (by subjectt 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), stable dose for at least 4 weeks prior to Screening and willingness to continue that dose for the study duration.
- •7) If subject 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.
- •9) Female subjects must be either post-menopausal for at least 1 year with FSH level >30 mIU/mL at Screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and either agree to use dual methods of contraception, have a
- •partner who had a vasectomy, or agree to abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
- •Non-vasectomized male subjects with female partners of childbearing potential must agree to either abstain from sexual activity or agree to a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Exclusion 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.
- •- 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 subjects 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 subjects or subjects 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
研究者
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