ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Diseasethat failed conventional treatment

ZonMW0 个研究点目标入组 122 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•Age 18 or older; must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures.
•- Diagnosis of Crohn’s disease =3 months before screening.
•- Objective evidence of inflammation at baseline as defined by endoscopy with mucosal ulcers in the ileum or colon or both, and a SES-CD score of 3-15.
•- Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX or steroids (prednisolone =30 mg/dl or budesonide =9 mg per day) are permitted. Tapering of corticosteroids is mandatory.

•- Current use of i.v. corticosteroids.
•- Imminent need for in-hospital treatment.
•- Pregnancy or lactation.
•- Previous or current treatment with investigational drug; current or past treatment within 6 months prior to randomization with a biological agent.
•- Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
•- Other significant illnesses that may interfere with the study, stricture causing obstructive symptoms, or fistulising disease complicated by infection,
•- Opiates use or drugs and/or alcohol abuse.
•- Concomitant use of TNA alpha antagonist, Integrin antagonist, Interleukin antagonist, Cyclosporine, thalidomide, tacrolimus and any JAK inhibitors. Wash out period mandatory.

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