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Crohn's DiseasePhase 2PIONEER-CDNCT02793778

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

A Phase 2 study testing CROWN in people with Crohn's Disease, run by Prometheus Laboratories at 39 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Crohn's Disease
What is being tested?
CROWN
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
39 sitesUnited States
Study dates
Jul 2016to 1 Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • CROWN Site 0014

    Ann Arbor, Michigan, 48109

  • CROWN Site 0012

    Asheville, North Carolina, 28801

  • CROWN Site 0030

    Aurora, Colorado, 80045

  • CROWN Site 0002

    Bastrop, Louisiana, 71220

  • CROWN Site 0003

    Baton Rouge, Louisiana, 70809

  • CROWN Site 0098

    Bellevue, Washington, 98004

  • CROWN Site 0028

    Bridgeport, Connecticut, 06606

  • CROWN Site 0018

    Chapel Hill, North Carolina, 27599

  • Crown Site 0006

    Chesterfield, Michigan, 48047

  • CROWN Site 0051

    Chevy Chase, Maryland, 20815

  • CROWN Site 0081

    Chicago, Illinois, 60611

  • CROWN Site 0019

    Crestview Hills, Kentucky, 41017

  • CROWN Site 0032

    Dothan, Alabama, 36305

  • CROWN Site 0020

    Great Neck, New York, 11021

  • CROWN Site 0041

    Hermitage, Tennessee, 37076

  • CROWN Site 0004

    Houston, Texas, 77030

  • CROWN Site 0086

    Houston, Texas, 77030

  • CROWN Site 0011

    Huntsville, Alabama, 35801

  • CROWN Site 71

    Lebanon, New Hampshire, 03756

  • CROWN Site 0091

    Little Rock, Arkansas, 72212

  • CROWN Site 0017

    Los Angeles, California, 90033

  • CROWN Site 0009

    Milwaukee, Wisconsin, 53215

  • CROWN Site 0084

    Mineola, New York, 11501

  • CROWN Site 0096

    Naples, Florida, 34102

  • CROWN Site 0016

    Norfolk, Virginia, 23502

  • CROWN Site 0007

    Orem, Utah, 84058

  • CROWN Site 0033

    Philadelphia, Pennsylvania, 19104

  • CROWN Site 0040

    Philadelphia, Pennsylvania, 19140

  • CROWN Site 0093

    Portland, Oregon, 97210

  • CROWN Site 0039

    Poughkeepsie, New York, 12601

  • CROWN Site 0034

    Raleigh, North Carolina, 27612

  • CROWN Site 0094

    Rapid City, South Dakota, 57701

  • CROWN Site 0054

    Rialto, California, 92377

  • CROWN Site 0021

    Rocky Mount, North Carolina, 27804

  • CROWN Site 0029

    Shreveport, Louisiana, 71105

  • CROWN Site 0036

    Topeka, Kansas, 66606

  • CROWN Site 0050

    Urbana, Illinois, 61801

  • CROWN Site 0013

    Ventura, California, 93003

  • CROWN Site 0073

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF Therapy

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)

Read the 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.

Conditions
Crohn's Disease
Being tested
CROWN, CROWN Placebo
Keywords
Crohn's Disease, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, mucosal healing, inflammatory bowel disease, Medical Food, Nutritional intervention
Medical subject headings
Crohn Disease, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CROWNDrug

    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 PlaceboDrug

    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

Study groups in NCT02793778
Study groupRoleWhat they receive
CROWNExperimentalCROWN: 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
Receives: Drug: CROWN
CROWN PlaceboPlacebo comparatorPlacebo: 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
Receives: Drug: CROWN Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Week 24

Secondary outcomes (6)

  1. Plasma amino acid level

    Change from baseline in plasma amino acid levels

    Measured: Week 12 and at Week 24

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

    Change from baseline in quality of life score in IBDQ

    Measured: Weeks 12 and 24

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

    Change from baseline in quality of life score in WPAI-CD

    Measured: Weeks 12 and 24

  4. Inflammatory biomarkers

    Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)

    Measured: Week 24

  5. 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)

    Measured: Week 24

  6. Corticosteroid-free

    Proportion of subjects who are corticosteroid-free

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Why it stopped: enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793778
Sponsor's protocol ID
13.06.CLI
Acronym
PIONEER-CD
Status last verified
Jun 2019
First submitted
1 Jun 2016
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CROWN in people with Crohn's Disease, run by Prometheus Laboratories at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Simple Endoscopic Score - Crohn's Disease (SES-CD) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02793778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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