A Phase 2 interventional study of CROWN and CROWN Placebo in Crohn's Disease, sponsored by Prometheus Laboratories. Terminated at 39 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by Prometheus Laboratories · Phase 2, Interventional, and Treatment
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)
The purpose of this study is to evaluate the effectiveness of an orally administered nutritional intervention (CROWN) in subjects with Crohn's Disease (CD) to support Standard Of Care (SOC) treatment in the repair and maintenance of the intestinal mucosa over a 24 week period. SOC is defined as having been on a stable maintenance dose of an anti-Tumor Necrosis Factor (TNF) agent within 24 weeks of its initiation.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 42 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Prometheus Laboratories is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Subjects with one or more of the following criteria are excluded from participation in the study:
CROWN: A nutritionally based therapy with a high protein content, formulated as a powder. Twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
Drug: CROWN
Placebo: An appearance and volume matched formulated powder. Twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
Drug: CROWN Placebo
A nutritionally based therapy, formulated as a powder, administered twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
Placebo, formulated as a powder, administered twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
Simple Endoscopic Score - Crohn's Disease (SES-CD)
Measuring intestinal health improvement is the Week 24 change from baseline in Simple Endoscopic Score - Crohn's Disease (SES-CD)
Time frame: Week 24
Plasma amino acid level
Change from baseline in plasma amino acid levels
Time frame: Week 12 and at Week 24
Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ)
Change from baseline in quality of life score in IBDQ
Time frame: Weeks 12 and 24
Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD)
Change from baseline in quality of life score in WPAI-CD
Time frame: Weeks 12 and 24
Inflammatory biomarkers
Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)
Time frame: Week 24
Endoscopic response
Proportion of subjects with endoscopic response based on SES-CD score, defined as a decrease in the SES-CD of at least 3 points from baseline, and no worsening of either component of the PRO2 (abdominal pain or liquid or soft stool frequency)
Time frame: Week 24
Corticosteroid-free
Proportion of subjects who are corticosteroid-free
Time frame: Week 12
Plan to share: No
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This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Prometheus Laboratories