EUCTR2016-001833-29-GB进行中（未招募）1 期
A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects 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
- 48
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
入选标准
- •1. Between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- •TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- •2. Subjects that do not have any medical conditions, other than active UC, that in the opinion of the Investigator put the subject at unacceptable risk or interfere with study assessments or integrity of the data. These medical conditions should be stable at the time of screening and are expected to remain stable for the duration of the study.
- •3. Subject has had a confirmed diagnosis of active UC, as documented by complete diagnostic colonoscopy to the terminal ileum (TI) with biopsy at least =3 months prior to screening. If diagnostic colonoscopy was not performed to the TI, it must be documented by the PI that the subject has diffuse inflammation from the rectum extending proximally to the colon in a continuous and uniform way.
- •4. A Complete Mayo Score of =3 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment with at least 1 of the following (oral corticosteroids or any oral 5-aminosalicylates (5-ASA) or purine analogues or all as defined below):
- •a. Oral 5-ASA at a stable dose (equivalent to = 2.4 g/day of Asacol) for at least 4 weeks prior to first dose. Must remain on a stable dose until end of treatment.
- •b. Purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate for at least12 weeks prior to first dose. Must remain on a stable dose until end of treatment.
- •c. Stable low dose oral corticosteroid (up to 20 mg prednisolone or equivalent) for 2 weeks prior to sigmoidoscopy. Must remain on a stable dose until end of treatment.
- •5. If on rectal 5-ASA or corticosteroids, must remain on a stable dose for at least 4 weeks prior to first dose. Must remain on stable dose until the end of treatment.
- •6. Subject is naive to any biological therapies for UC.
- •Subject may have had previous exposure to a single anti-TNF biologic agent which was discontinued for reasons other than primary non-response more than 8 weeks (or 5 half lives whichever is longer) prior to first dose.
- •Subject may have had previous exposure to a single biologic agent (e.g., vedolizumab) in the context of a previous clinical trial. The biologic agent must have been discontinued more than 8 weeks (or 5 half lives whichever is longer) prior to first dose.
- •Note: Exposure to a single biologic agent is not required in addition to Inclusion #4 and #5 above.
- •7. A body mass index (BMI) within range of 18.5 – 35 kg/m2 (inclusive) at screening.
- •8. Male and female subjects:
- •Male subjects with female partners of child bearing potential must comply with the following contraception requirements in Appendix 6.
- •A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, and at least
- •one of the following conditions applies:
- •a. Non-reproductive
排除标准
- •CONCURRENT CONDITIONS/MEDICAL HISTORY
- •1.Subject with diagnosis of indeterminate colitis, Crohn’s Disease, infectious colitis, or ischemic colitis
- •2.Subject with fulminant UC, or UC limited to the rectum
- •3.Subject with previous small bowel or colonic surgery (with exception of appendectomy), histological evidence of colonic dysplasia or bowel stricture
- •4.Subject with colostomy, fistulae or known symptomatic stenosis of the intestine
- •5.Subject with toxic megacolon
- •6.Subject with positive Clostridium difficile toxin test or active/previous colonic CMV infection
- •7.Subject with current history of suicidal ideation behaviour as measures using the Columbia Suicide Severity Rating Scale or history of attempted suicide
- •8.An active infection, or a history of infections as follows:
- •-Hospitalisation for treatment of infection within 60 days before first dose
- •-Currently on any suppressive therapy for a chronic infection
- •-Use of parenteral intramu antibiotics for an infection within 60 days before first dose
- •-A history of opportunistic infections within 1 year of screening. This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature
- •-Recurrent or chronic infection or other active infection that, in the opinion of the Investigator might cause this study to be detrimental to the patient
- •-History of TB, irrespective of treatment status
- •-A positive diagnostic TB test at screening defined as a positive
- •QuantiFERON-TB Gold test or T-spot test. In cases where the QuantiFERON
- •or T-spot test is indeterminate, the subject may have the test repeated once, but they will not be eligible for the study unless the second test is negative. In cases where the QuantiFERON or T-spot test is positive, but a follow-up chest x-ray, locally read by a radiologist, shows no evidence of current or previous pulmonary tuberculosis, the subject may be eligible for the study at the discretion of the Investigator and GSK Medical Monitor
- •9.QTc > 450msec or QTc > 480msec for subjects with bundle branch block at screening.
- •The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual over read.
- •The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
- •10.ALT >2xULN and bilirubin >1.5xULN at screening
- •11.Current active or chronic history of liver or biliary disease
- •12.Current or history of renal disease or estimated glomerular filtration rate by Chronic Kidney Disease Epidemiology C
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