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

NCT02793778 | Terminated Phase 2 DMC

• 1 other identifier: 13.06.CLI
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 39

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)

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; mucosal healing; inflammatory bowel disease; Medical Food; Nutritional intervention

Outcome Measures

Primary Outcomes (1)

• 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)

  Week 24

Secondary Outcomes (6)

• Plasma amino acid level

  Week 12 and at Week 24

• Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ)

  Weeks 12 and 24

• Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD)

  Weeks 12 and 24

• Inflammatory biomarkers

  Week 24

• Endoscopic response

  Week 24

Study Arms (2)

CROWN

EXPERIMENTAL

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

CROWN Placebo

PLACEBO COMPARATOR

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

Interventions

CROWN DRUG

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

CROWN

CROWN Placebo DRUG

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

CROWN Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Prometheus Laboratories: lead
• Nestlé Health Science Spain: collaborator
• Nestec Ltd.: collaborator

Study Sites (39)

CROWN Site 0032

Dothan, Alabama, 36305, United States

Location

CROWN Site 0011

Huntsville, Alabama, 35801, United States

Location

CROWN Site 0091

Little Rock, Arkansas, 72212, United States

Location

CROWN Site 0017

Los Angeles, California, 90033, United States

Location

CROWN Site 0054

Rialto, California, 92377, United States

Location

CROWN Site 0013

Ventura, California, 93003, United States

Location

CROWN Site 0030

Aurora, Colorado, 80045, United States

Location

CROWN Site 0028

Bridgeport, Connecticut, 06606, United States

Location

CROWN Site 0073

Washington D.C., District of Columbia, 20007, United States

Location

CROWN Site 0096

Naples, Florida, 34102, United States

Location

CROWN Site 0081

Chicago, Illinois, 60611, United States

Location

CROWN Site 0050

Urbana, Illinois, 61801, United States

Location

CROWN Site 0036

Topeka, Kansas, 66606, United States

Location

CROWN Site 0019

Crestview Hills, Kentucky, 41017, United States

Location

CROWN Site 0002

Bastrop, Louisiana, 71220, United States

Location

CROWN Site 0003

Baton Rouge, Louisiana, 70809, United States

Location

CROWN Site 0029

Shreveport, Louisiana, 71105, United States

Location

CROWN Site 0051

Chevy Chase, Maryland, 20815, United States

Location

CROWN Site 0014

Ann Arbor, Michigan, 48109, United States

Location

Crown Site 0006

Chesterfield, Michigan, 48047, United States

Location

CROWN Site 71

Lebanon, New Hampshire, 03756, United States

Location

CROWN Site 0020

Great Neck, New York, 11021, United States

Location

CROWN Site 0084

Mineola, New York, 11501, United States

Location

CROWN Site 0039

Poughkeepsie, New York, 12601, United States

Location

CROWN Site 0012

Asheville, North Carolina, 28801, United States

Location

CROWN Site 0018

Chapel Hill, North Carolina, 27599, United States

Location

CROWN Site 0034

Raleigh, North Carolina, 27612, United States

Location

CROWN Site 0021

Rocky Mount, North Carolina, 27804, United States

Location

CROWN Site 0093

Portland, Oregon, 97210, United States

Location

CROWN Site 0033

Philadelphia, Pennsylvania, 19104, United States

Location

CROWN Site 0040

Philadelphia, Pennsylvania, 19140, United States

Location

CROWN Site 0094

Rapid City, South Dakota, 57701, United States

Location

CROWN Site 0041

Hermitage, Tennessee, 37076, United States

Location

CROWN Site 0004

Houston, Texas, 77030, United States

Location

CROWN Site 0086

Houston, Texas, 77030, United States

Location

CROWN Site 0007

Orem, Utah, 84058, United States

Location

CROWN Site 0016

Norfolk, Virginia, 23502, United States

Location

CROWN Site 0098

Bellevue, Washington, 98004, United States

Location

CROWN Site 0009

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Crohn Disease; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Inflammatory Bowel Diseases

Interventions

Crowns

Condition Hierarchy (Ancestors)

Gastroenteritis

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• James Lewis, M.D.

  University of Pennsylvania

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 8, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)