LBCTR2020043427已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 至 80（—）
- 性别
- All
入选标准
- •Subjects must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Men or women 16 to 80 years of age, inclusive, at the time of assent/consent
- •2. Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age who has assented to participate in the study or as required per local regulations) and to be compliant with the schedule of protocol assessments
- •Disease-specific inclusion criteria:
- •3. Diagnosed with UC = 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. The endoscopy and histology report should be present in the source documents; however, if not available, the screening endoscopy and
- •histology may serve as such
- •4. Active UC confirmed by endoscopy with = 10 cm rectal involvement. Inclusion of subjects with proctitis only at baseline will be capped at 15% of the total subjects enrolled.
- •5. Moderately to severely active UC defined as MMS of 4 to 9, including an ES of = 2 and RB score = 1
- •6. Received a surveillance colonoscopy (performed according to local standard) within 12 months before baseline to rule out dysplasia in subjects with pancolitis > 8 years duration or subjects with left-sided colitis > 12 years duration. Subjects without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at screening (ie, in place of screening proctosigmoidoscopy). Any adenomatous polyps must be removed prior to their first dose of study treatment.
- •Prior treatment:
- •7. Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies as defined below:
- •Conventional therapy
- •a. Oral 5-aminosalicylic acid (5-ASA) compounds
- •b. Corticosteroids
- •c. Thiopurines
- •Biologic therapy or JAK inhibitor therapy
- •a. Antitumor necrosis factor alpha (TNFa) antibodies (eg, infliximab, adalimumab,
- •golimumab, or biosimilars)
- •b. Anti-integrin antibodies (eg, vedolizumab)
- •c. JAK inhibitors (eg, tofacitinib)
- •Note: The medication used to qualify the subject for entry into this category must be
- •approved for the treatment of UC in the country of use.
- •Concomitant treatments:
- •8. Subjects are permitted to be receiving a therapeutic dose of the following drugs:
- •Oral 5-ASA compounds provided the dose has been stable for = 2 weeks immediately
- •prior to randomization
- •Oral corticosteroid therapy (prednisone at a stable dose = 20 mg/day, budesonide at a
- •stable dose = 9 mg/day, or equivalent steroid) provided the dose has been stable for the
- •4 weeks immediately prior to the screening endoscopy assessment
- •Immunosuppressive agents such as oral azathioprine or 6-mercaptopurine must be
- •discontinued = 2 weeks prior to randomization
- •Probiotics (eg, Culturelle®, Saccharomyces boulardii) provided the dose has been
- •stable for the 2 weeks immediately prior to randomization
- •Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic
- •If oral aminosalicylates or corticosteroids have been recently discontinued, they must have
- •been stopped for at least 2 weeks prior to the endoscopy used for the baseline MMS.
- •Other general inclusion criteria:
- •9. Vital signs at screening and prerandomization taken in the sitting position: heart rate
- •= 50 bpm, systolic blood pressure (BP) = 90 mm Hg, and diastolic BP = 55 mm Hg
- •10.Screening and pre-randomization 12-lead electrocardiogram (ECG) showi
排除标准
- •Exclusions related to general health:
- •1. Severe extensive colitis as evidenced by:
- •Physician judgment that the subject is likely to require hospitalization for medical care
- •or surgical intervention of any kind for UC (eg, colectomy) within 12 weeks of baseline
- •Current evidence of fulminant colitis, toxic megacolon or recent history (within last
- •6 months) of toxic megacolon, or bowel perforation
- •Previous total or partial colectomy
- •2. Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula
- •consistent with Crohn’s disease
- •3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- •4. Hospitalization for exacerbation of UC requiring intravenous (IV) steroids within 12 weeks
- •of screening (a single dose of IV steroids given is acceptable)
- •5. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or
- •positive test for Clostridium difficile toxin at screening (If C. difficile is positive, the
- •subject may be treated and retested = 4 weeks after completing treatment)
- •6. Pregnancy, lactation, or a positive serum ß-hCG measured during screening
- •7. Clinically relevant hematologic, hepatic, neurological, pulmonary, ophthalmological,
- •endocrine, metabolic (including, but not limited to, hypo- and hyperkalemia), psychiatric or
- •other major systemic disease making implementation of the protocol or interpretation of the
- •study difficult or would put the subject at risk
- •8. Recent history (within 2 months of the Screening Visit) of cardiovascular disease,
- •including myocardial infarction or unstable angina
- •9. Any history of the following, unless treated with an implanted pacemaker or an implanted
- •cardioverter-defibrillator with pacing:
- •History or presence of symptomatic bradycardia
- •History of sick sinus syndrome or neurocardiogenic syncope
- •Second or third-degree atrioventricular (AV) block
- •Periods of asystole > 3 seconds
- •10.Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 70% of
- •predicted values and FEV1/FVC ratio < 0.70 at screening
- •11.Uncontrolled diabetes as determined by hemoglobin A1c (HbA1c) > 9% at screening, or
- •subjects with diabetes with significant comorbid conditions such as retinopathy
- •12.History of macular edema or retinopathy
- •13.Current or past history of active tuberculosis (TB), history of untreated latent TB infection,
- •or test positive for latent TB infection at screening. The following are EXCEPTIONS to
- •this exclusion criteria:
- •Subjects with latent TB, who have been ruled out for active TB, have completed an
- •appropriate course of TB prophylaxis treatment per national/local medical guidelines
- •or WHO guidelines, and have not had recent close contact with a person with active
- •TB are eligible to enroll in the study. It is the responsibility of the Investigator to verify
- •the adequacy of previous TB treatment and provide appropriate documentation
- •Subjects diagnosed with latent TB at screening, ruled out for active TB and received at
- •least 4 weeks of an appropriate TB prophylaxis regimen may be rescreened for
- •Note: The 2 exceptions to this exclusion criterion outlined above do NOT apply to subjects
- •in countries identified by WHO as a high multi-drug resistant TB burden country due to the
- •high risk of latent infection with multi-drug resistance.
- •14.Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including
- •TB or atypical mycobac
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