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

Prometheus Laboratories

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: CROWN; Drug: CROWN Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02793778

13.06.CLI

Details and patient eligibility

About

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)

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

CROWN

Experimental group

Description:

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

Treatment:

Drug: CROWN

CROWN Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: CROWN Placebo