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

Phase 2

Terminated

• Conditions: Crohn's Disease
• Interventions: Drug: CROWN; Drug: CROWN Placebo

• Registration Number: NCT02793778
• Lead Sponsor: Prometheus Laboratories

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Study Start: 2016-07
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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.

1. Adults (18-85 years of age) with a known history of symptomatic CD confirmed by endoscopy or radiology
2. CDAI score ≤ 350
3. Active endoscopic disease (SES-CD score ≥ 6) documented during the study screening phase or SES-CD score ≥ 4 if isolated ileal disease
4. On a stable dose of infliximab, adalimumab, or certolizumab therapy for 8 weeks prior to randomization as part of SOC
5. Able to consume oral nutrition for up to 24 weeks consisting of two 4 oz (120 ml) servings daily
6. 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

Exclusion Criteria

Subjects with one or more of the following criteria are excluded from participation in the study:

1. 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
2. Fistula known to be contributing to diarrhea
3. Recent or current history of bowel obstruction
4. Stricturing disease with evidence of bowel dilation proximal to stricture on imaging
5. Anticipated need for gastrointestinal surgical therapy in the next 6 months
6. Current treatment with a systemic corticosteroid at dose greater than 20 mg of prednisone (or equivalent) at screening
7. Change in any antimetabolite therapy within 8 weeks prior to randomization
8. Current treatment with antibiotics for CD (ciprofloxacin, metronidazole) at screening
9. Current ostomy
10. Serious infection, neoplasia or other medical conditions which would interfere with participation in the study, in the opinion of the Investigator
11. Evidence of Clostridium difficile infection in the previous 4 weeks
12. History of non-compliance with clinical protocols
13. Active participation in another CD trial or received an investigational product within the past 4 weeks
14. Diagnosis of celiac disease
15. Known sensitivity to milk or soy protein
16. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CROWN	CROWN	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
CROWN Placebo	CROWN Placebo	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

Primary Outcome Measures

Name	Time	Method
Simple Endoscopic Score - Crohn's Disease (SES-CD)	Week 24	Measuring intestinal health improvement is the Week 24 change from baseline in Simple Endoscopic Score - Crohn's Disease (SES-CD)

Secondary Outcome Measures

Name	Time	Method
Plasma amino acid level	Week 12 and at Week 24	Change from baseline in plasma amino acid levels
Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ)	Weeks 12 and 24	Change from baseline in quality of life score in IBDQ
Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD)	Weeks 12 and 24	Change from baseline in quality of life score in WPAI-CD
Inflammatory biomarkers	Week 24	Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)
Endoscopic response	Week 24	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)
Corticosteroid-free	Week 12	Proportion of subjects who are corticosteroid-free

Trial Locations

Locations (39)

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, District of Columbia, United States

CROWN Site 0096; 🇺🇸 Naples, Florida, United States

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