EUCTR2018-003986-33-BE进行中（未招募）1 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 - ELEVATE UC 12
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- •1. Men or women 16 to 80 years of age, inclusive, at the time of
- •assent/consent. Enrollment of subjects < 18 years should be conducted
- •only if acceptable according to local laws and regulations
- •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.
- •Subjects with proctitis only at baseline,who meet the other eligibility
- •criteria, including the endoscopic and rectal bleeding
- •criteria for moderate to severe disease, 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 12m 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 12m will have a colonoscopy at screening (ie, in
- •place of screening proctosigmoidoscopy). Any adenomatous polyps must be removed according to routine practice prior to their first dose of study 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. Anti-interleukin 12/23 antibodies (eg, ustekinumab)
- •d. JAK inhibitors (eg, tofacitinib)
- •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 = 2w 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
- •If oral 5-ASA or corticosteroids have been recently discontinued, they
- 另有 3 项未显示
排除标准
- •1. Severe extensive colitis as evidenced by:
- •Physician judgement that the subject is likely to require hospitalization for medical care or surgical intervention for UC within 12w following randomization
- •Current evidence of fulminant colitis, toxic megacolon or recent history
- •(last 6m) of toxic megacolon, or bowel perforation
- •Previous total or partial colectomy
- •2. Diagnosis of CD or indeterminate colitis or the presence or history of a fistula consistent with CD
- •3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- •4. Hospitalization for exacerbation of UC requiring IV steroids within
- •12w of screening
- •5. Positive assay or stool culture for pathogens or positive test for
- •Clostridioides difficile toxin at screening
- •6. Pregnancy, lactation, or a +ve serum ß hCG at screening
- •7. Clinically relevant neurological, endocrine, metabolic, psychiatric,
- •cognitive impairment, alcohol/drug abuse/dependence, or other major systemic disease making implementation of the protocol or
- •interpretation of the study difficult or would put the subject at risk.
- •8.Have any of the following conditions or receiving treatments that may affect cardiovascular function:
- •Myocardial infarction, unstable angina, stroke/transient ischemic
- •attack, decompensated heart failure requiring hospitalization or Class
- •III/IV heart failure = 6m prior to or during the Screening Period
- •History or presence of :
- •second or third-degree AV block, sick sinus syndrome, or periods of
- •asystole for > 3 seconds without a functional pacemaker;recurrent
- •symptomatic bradycardia or recurrent cardiogenic syncope
- •Screening and or W0/Day 1 prerandomization vital signs with a heart rate (HR) < 50 bpm OR systolic blood pressure (BP) < 90 mm Hg OR diastolic BP < 55 mm Hg.
- •Screening and or W0/Day 1 prerandomization ECG with PR interval > 200 ms or Fridericia's corrected QT interval = 450 ms in men or = 470 ms in women
- •Start, stop, change or planned change in dosage of any anti-arrhythmic drugs (Class I to IV) = 1w b4 screening or within 1w b4 or after randomization
- •9. Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 70% of predicted values and FEV1/FVC ratio < 0.70 at
- •10.Uncontrolled diabetes as determined by hemoglobin A1c (HbA1c) > 9% at screening, or subjects with diabetes with significant comorbid conditions such as retinopathy
- •11. History of macular edema or retinopathy
- •12.History of active tuberculosis (TB), history of untreated or
- •inadequately treated latent TB infection, active or latent TB infection at screening.
- •13.A clinically significant active infection = 28 days prior to
- •randomization, required iv medication = 14 days prior to randomization, or that may worsen if the subject is treated with a drug having immunosuppressant effects
- •14. Have HIV/acquired immune deficiency syndrome or test positive for HIV antibodies at screening
- •15. Have acute or chronic hepatitis B infection or test positive for
- •hepatitis B virus (HBV) at screening
- •16. Have current hep C infection or test positive for hep C virus (HCV) at screening as defined by positive for hep C antibody and detectable HCV RNA
- •17. History of an opportunistic infection or history of disseminated
- •herpes simplex or disseminated herpes zoster
- •18. History of or currently active primary or secondary immunodeficiency
- •19. History of cancer within the last 5y
- •20. History of lymphoproliferative disorder, lymphoma, leukemia,
- •myeloproliferative disorder, or multiple myeloma
- •21. Hyperse
研究者
相似试验
进行中（未招募）
不适用
A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous for the F508del-CFTR MutationMedDRA version: 17.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-003989-40-NLVertex Pharmaceuticals Incorporated501
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisEUCTR2018-003986-33-GBArena Pharmaceuticals, Inc.330
进行中（未招募）
1 期
A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)EUCTR2018-000226-58-BGPfizer Inc., 235 East 42nd Street, New York, NY 10017240
进行中（未招募）
不适用
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia - LVHJMen with benign prostatic hyperplasiaMedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasiaEUCTR2008-002841-21-ITEli Lilly and Company521
进行中（未招募）
1 期
A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous for the F508del-CFTR MutationMedDRA version: 16.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-003990-24-DKVertex Pharmaceuticals Incorporated501