Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab, certolizumab)

Key facts

Study ID

NCT02793778

Run by

Prometheus Laboratories

People needed

42

Starts

2016-07-01

Expected to finish

2018-06-01

Last updated by the study team

2019-06-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Crohn's Disease patient who has derived clinical benefit from the Standard of Care therapy, but continues to have evidence of incomplete healing of the intestinal mucosa.
• Adults (18-85 years of age) with a known history of symptomatic CD confirmed by endoscopy or radiology
• CDAI score ≤ 350
• Active endoscopic disease (SES-CD score ≥ 6) documented during the study screening phase or SES-CD score ≥ 4 if isolated ileal disease
• On a stable dose of infliximab, adalimumab, or certolizumab therapy for 8 weeks prior to randomization as part of SOC
• Able to consume oral nutrition for up to 24 weeks consisting of two 4 oz (120 ml) servings daily
• Able to understand the informed consent process, willing to follow study instructions and likely to complete all required visits and procedures, including the use of an electronic device to collect study data, home computer or tablet and internet access to complete online food frequency questionnaire, and undergo 2 endoscopies in a 6 month period

You may not qualify if…

• Subjects with one or more of the following criteria are excluded from participation in the study:
• If female, subject is pregnant, nursing, or planning to become pregnant during the study period or is of childbearing potential and unable or unwilling to use a reliable form of contraception during the study
• Fistula known to be contributing to diarrhea
• Recent or current history of bowel obstruction
• Stricturing disease with evidence of bowel dilation proximal to stricture on imaging
• Anticipated need for gastrointestinal surgical therapy in the next 6 months
• Current treatment with a systemic corticosteroid at dose greater than 20 mg of prednisone (or equivalent) at screening
• Change in any antimetabolite therapy within 8 weeks prior to randomization
• Current treatment with antibiotics for CD (ciprofloxacin, metronidazole) at screening
• Current ostomy
• Serious infection, neoplasia or other medical conditions which would interfere with participation in the study, in the opinion of the Investigator
• Evidence of Clostridium difficile infection in the previous 4 weeks
• History of non-compliance with clinical protocols
• Active participation in another CD trial or received an investigational product within the past 4 weeks
• Diagnosis of celiac disease
• Known sensitivity to milk or soy protein
• In the Investigator's opinion, subject has any condition or situation which makes the subject unsuitable for study participation, may put the subject at significant risk, or may confound the study results

Where it is running

• CROWN Site 0032 — Dothan, Alabama, United States
• CROWN Site 0011 — Huntsville, Alabama, United States
• CROWN Site 0091 — Little Rock, Arkansas, United States
• CROWN Site 0017 — Los Angeles, California, United States
• CROWN Site 0054 — Rialto, California, United States
• CROWN Site 0013 — Ventura, California, United States
• CROWN Site 0030 — Aurora, Colorado, United States
• CROWN Site 0028 — Bridgeport, Connecticut, United States
• CROWN Site 0073 — Washington D.C., District of Columbia, United States
• CROWN Site 0096 — Naples, Florida, United States
• CROWN Site 0081 — Chicago, Illinois, United States
• CROWN Site 0050 — Urbana, Illinois, United States
• CROWN Site 0036 — Topeka, Kansas, United States
• CROWN Site 0019 — Crestview Hills, Kentucky, United States
• CROWN Site 0002 — Bastrop, Louisiana, United States
• CROWN Site 0003 — Baton Rouge, Louisiana, United States
• CROWN Site 0029 — Shreveport, Louisiana, United States
• CROWN Site 0051 — Chevy Chase, Maryland, United States
• CROWN Site 0014 — Ann Arbor, Michigan, United States
• Crown Site 0006 — Chesterfield, Michigan, United States
• CROWN Site 71 — Lebanon, New Hampshire, United States
• CROWN Site 0020 — Great Neck, New York, United States
• CROWN Site 0084 — Mineola, New York, United States
• CROWN Site 0039 — Poughkeepsie, New York, United States
• CROWN Site 0012 — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.