NL-OMON55008已完成2 期
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Subjects with Active Eosinophilic Esophagitis - AK002 in EoE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allakos Inc.
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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 the 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 subjject 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
- •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.
排除标准
- •1) Concomitant moderately or severely symptomatic EG and/or (with or without
- •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
- •an 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 subjects 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 critiacal esophageal stricture that requires
- •dilatation 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 Heliobacter pylori infection as determined by central histology
- •staining of the biopsy collected during the Screening EGD, unless treated and
- •confirmed to be negtive prior to randomization and symptoms remain consistent.
- •8) Positive Ova and Parasite (O&P) 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.
- •Exclusion Criteria cont.
- •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.
- 另有 1 项未显示
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