Phase IIa examination of the effect of oral dosing of NV-52 on surrogate markers of inflammatory bowel disease (IBD) in patients with stable disease but with a consistent abnormality in one or more surrogate marker.

ovogen Research Pty Ltd0 个研究点目标入组 10 人开始时间: 2007年11月29日最近更新: 2020年1月13日

试验速览

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•1. healthy, (without clinically significant impairment in cardiac, liver or renal function, central nervous system, pulmonary, hematological, immunological, or vascular disease in addition to IBD, or current malignancy or malignancy within 5 years prior to screening) adults > 18 years old
•2. presenting with either UC or CD affecting colon, ideally with an even distribution of both disease types across the patient population.
•3. stable but active mild disease defined as: an abnormal level (as defined by the reference laboratory) of at least one of the surrogate markers at both screening visits (The abnormality must occur in the same marker at both screening visits.)
•4. The patients’ assessment of their own disease will include evidence of active but mild and stable disease eg 1-2 stools/day more than usual, or occasional streaks of blood. Patients will be trained in using this scoring system.
•5. The physician’s empirical (gestalt) assessment will categorise the patient as having mild overall disease.
•6. patients must be able to understand the risks and benefits of the study and give written informed consent to participation
•7. Subjects of childbearing potential that agree to use contraception, or ensure that their sexual partner be using contraception which must be either oral contraceptives, implantable hormonal contraceptives, or double-barrier methods throughout the trial

•1. patients whose symptoms deteriorate to the point of acute relapse (CDAI > 200, UCAI > 4). 2. a change in current medication within the last 4 weeks. 3. the use of steroids (excluding inhaled asthma medications) within the last 4 weeks. 4. the use of biologicals (eg monoclonal antibodies) within the last 4 weeks. 5. the use of trial medications within the last four weeks. 6. the use of rectal preparations. 7. a return to normal levels of all surrogate markers (CRP, ESR, platelets and faecal calprotectin) during the screening period (Day -14 – Day +1) ie at least one surrogate marker must be elevated at day1. If the results of the samples collected on Day 1, prior to drug being administered, show that markers have returned to normal levels, the patient will be excluded. 8. pregnant or lactating women or subjects not using adequate contraception.

发起方

ovogen Research Pty Ltd