EUCTR2018-003278-28-CZ进行中（未招募）1 期
A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •AGE and WEIGHT: Participant must be 18 years of age or older and >40kg at the time of signing the informed consent.
- •TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS:
- •Participants who have a:
- •-Diagnosis of ulcerative colitis, established at least 3 months prior to screening, as documented by diagnostic sigmoidoscopy or colonoscopy, and biopsy.
- •-Complete 4-domain Mayo Score of 6 to 12, with disease extending =15cm from the anal verge, with a centrally read endoscopic subscore of =2 at screening endoscopy, and a rectal bleeding subscore =1.
- •-A history of at least one of the following:
- •(1) Inadequate response to, loss of response to, or intolerance to azathioprine or mercaptopurine (including thiopurine methyltransferase (TPMT) and NUDT15 genetic mutations precluding use), ciclosporin, tacrolimus or methotrexate.
- •(2) Inadequate response to, loss of response to, intolerance to, or demonstrated dependence on oral corticosteroids.
- •(3) Inadequate response to, loss of response to, or intolerance to at least one approved advanced therapy for UC, including anti-TNF therapies, anti-integrin therapies, anti-IL-12/23 monoclonal antibodies or JAK inhibitors.
- •- Surveillance colonoscopy (performed according to local standards) within 12 months of screening (or during screening, if required) for participants with:
- •(1) Pancolitis of >8 years duration; or
- •(2) Patients with left-sided colitis of >12 years duration; or
- •(3) For patients for whom this criterion does not apply, colorectal cancer surveillance should be undertaken according to local or national guidelines for patients with age =50, or with other known risk factors for colorectal cancer.
- •Both male and female participants are eligible to participate.
- •Female participants:
- •- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •(1) Not a woman of childbearing potential (WOCBP),
- •(2) A WOCBP who agrees to use a highly effective contraceptive method for at least 4 weeks prior to dosing, until the Follow-Up visit.
- •INFORMED CONSENT
- •-Capable of giving signed informed consent as described in the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 202
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Medical Conditions
- •1) Current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, CD, infectious colitis, or ischaemic colitis
- •2) Fulminant UC (as defined by 6 bloody stools daily AND 1 or more of: i) body temperature =100.4°F (or 38°C) or ii) heart rate >90 beats per minute), or toxic megacolon
- •3) Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- •4) Any uncontrolled medical conditions, other than active UC, that in the opinion of the investigator put the participant at unacceptable risk or interfere w/ study assessments or integrity of the data. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study
- •5) Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the investigator they would interfere w/ the ability of a participant to complete the study
- •6) An active infection or a history of serious infections as described in the protocol
- •7) Current or history of chronic liver or biliary disease w/ the exception of Gilbert's syndrome, asymptomatic gallstones or uncomplicated fatty liver disease
- •8) Hereditary/acquired immunodeficiency disorder, including immunoglobulin deficiency unless the participant has a documented history of elective IgA deficiency
- •9) A major organ transplant or haematopoietic stem cell/marrow transplant
- •10) Any planned major surgical procedure during the study
- •11) A history of malignant neoplasm w/in the last 5 yrs, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (w/in 1 yr) or carcinoma in situ of the uterine cervix (w/in 3 yrs) that has been fully treated and shows no evidence of recurrence PRIOR/CONCOMITANT THERAPY:
- •12) A change in dose of oral sulfasalazine or aminosalicylate w/in 2 wks prior to baseline endoscopy
- •13) >20mg/day oral prednisolone, or a change in dose of corticosteroid w/in 2 wks prior to baseline endoscopy, or anticipated inability to maintain a stable dose of corticosteroids (=20 mg oral prednisolone or equivalent) until Wk12
- •14) Topical(rectal) corticosteroids or topical(rectal) aminosalicylate w/in 2 wks prior to baseline endoscopy
- •15) Initiation/change in dose of mercaptopurine or azathioprine (including initiation/discontinuation of allopurinol) or methotrexate w/in 8 wks prior to baseline endoscopy
- •16) Treatment w/ ciclosporin, tacrolimus or thalidomide w/in 4 wks prior to baseline endoscopy
- •17) Treatment w/ an anti-TNF biologic w/in 8 wks prior to baseline endoscopy, anti-integrin or anti-IL-12/23 biologics w/in 12 wks prior to baseline endoscopy, or a JAK inhibitor w/in 4 wks prior to baseline endoscopy
- •18) History of inadequate response, loss of response, or intolerance to more than 3 classes of approved advanced therapies for UC (including anti-TNF therapies, anti-integrin therapies, anti-IL-12/23 monoclonal antibodies, or JAK inhibitors; but excluding exposure w/in a clinical trial setting), of which participants must not have had inadequate response to more than 2 classes
- •19) Received faecal microbiota transplantation w/in 4 wks prior to baseline endoscopy
- •20 Received live vaccination w/in 4 wks of Day 1 or plan to receive during the study until Follow-Up
- •PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE:
- •21) Participated in a clinical trial and received an IP w/in the following time period prior to this study's screening endoscopy da
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