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

Recruiting

Conditions: Crohn's disease (CD)

Registration Number: NL-OMON21939

Lead Sponsor: ZonMW

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 122

Inclusion Criteria

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.

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoscopic remission at week 12 defined as SES-CD =4 and ulcerated surface subscore =1 in all five segments

Secondary Outcome Measures

Name	Time	Method
- Proportion of patient in steroid free clinical remission<br>- Response defined by a decrease in HBI of =3 points compared to baseline and endoscopic response defined as a reduction of SES-CD score by =50% vs baseline at week 12<br>- Changes in laboratory measures of inflammation (CRP, fecal calprotectin) from baseline at week 12,24 and 52<br>- Adverse events at every visit<br>- Response at week 24 and 52 (HBI)<br>- Endoscopic remission and response at week 52<br>- Quality of life, fatigue, anxiety, depression, sleepdisturbance, healthcare costs, workdisability