EUCTR2018-002001-65-GB进行中（未招募）1 期
A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •A patient will be eligible for inclusion in this study only if all of the following criteria apply:
- •1.Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications. (see Section 7.11 for additional information)
- •2.Patients that have been diagnosed with moderate to severe Crohn’s disease for at least 3 months prior to Screening Visit 1 defined by CDAI score between 220-450
- •3.Patients are required to have endoscopic evidence of active Crohn’s disease at Baseline (screening visit 1) defined by endoscopic appearance: SES-CD excluding the narrowed component of = 6 (or =4 for patients with isolated ileal disease).
- •4.AST and ALT = 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •5.Male or female participants aged =16 years (up to 80 years)
- •Male participants:
- •6.A male participant must agree to use contraception as detailed in Appendix 5 of this protocol for at least 180 days post-dose of study medication and refrain from donating sperm during this period.
- •Female participants:
- •7.A female participant is eligible to participate if she is not pregnant or breastfeeding and not a woman of childbearing potential (WOCBP) defined as at least one of the following conditions:
- •i.Premenopausal female with documented hysterectomy
- •iiPremenopausal female with documented bilateral salpingectomy or oophorectomy
- •iii.Postmenopausal female defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •iv.Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the trial. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before trial enrolment.
- •v.A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 for at least 180 days post-dose of trial medication. If a hormonal method of birth control is selected from the list in Appendix 1 then participants must have been using these methods at least 28 days prior to GSK1070806 administration, or be abstinent, or utilise a condom as a method of contraception until the selected hormonal method has been in place for the 28 day period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •A participant will not be eligible for inclusion in this trial if any of the following criteria apply:
- •1.Diagnosis of ulcerative or indeterminate colitis
- •Crohn’s Disease complications:
- •2.Evidence of an infected abscess by MRI or other examinations
- •3.Bowel surgery other than appendectomy within 12 weeks prior to screen and/or has planned surgery or deemed likely to need surgery for CD during the trial period
- •4.Participants with ileostomies, colostomies or rectal pouches
- •5.Participants with a bowel stricture that is fixed
- •6.Participants with evidence of short bowel syndrome
- •7.Participants requiring enteral or parenteral feeding
- •8.Deep penetrating ulcers at endoscopy thought to be at risk for perforation
- •Viral and bacterial infections:
- •9.Presence of Hepatitis B surface antigen (HBsAg), (confirmed by Hepatitis B surface antigen test – within 12 months of randomisation) core antigen (HBcAg) or surface antibody (HBsAb), positive Hepatitis C (qualitative enzyme immunoassay) test result
- •10.Known varicella, herpes zoster, or other severe viral infection within 6 weeks of randomisation
- •11.The participant has a history of tuberculosis (TB) disease or latent TB infection, in the absence of documented adequate therapy for same.
- •12.Positive screening test for TB (including T-SPOT.TB TB test), unless respiratory review confirms false positive test results
- •13.History of uncontrolled bacterial or fungal infection requiring intravenous antibiotics
- •14.Positive immunoassay for Clostridium difficile toxin and other enteric pathogens
- •Other exclusion criteria:
- •15.Cardiology assessment/co-morbidity defined as:
- •i.QTc >450 msec (480msec for those with Bundle Branch Block) and/or
- •ii.either QTcb or QTcf, machine or manual overread, males or females. The QT correction formula used to determine exclusion and discontinuation should be the same throughout the trial and/or
- •iii.based on single QTc value (average of triplicate readings) of ECG obtained over a brief recording period
- •16.The participant has congenital or acquired immunodeficiency, or a history of chronic or recurrent opportunistic infections
- •17.The participant has current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or cancer in situ that has been resected)
- •18.Use of any investigational drug within 30 days prior to screening, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- •19.Participant has received live, attenuated or recombinant vaccine(s) within 2 months of randomisation or will require vaccination within 3 months of trial drug infusion
- •20.Any patients that are receiving medication(s) detailed in Section 7.11.2 of the trial protocol, will not be eligible for randomisation into the trial
研究者
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