If you have any questions or are interested in participating in a clinical trial, please call (919) 843-9071 or send an e-mail to ibdtrials@med.unc.edu.

For detailed information about the eligibility criteria and requirements for each study, click on the ClinicalTrials.gov study identifier number.

Crohn’s • Ulcerative Colitis • IBD Registries

Crohn’s Disease Treatment Studies

Seavue

ClinicalTrials.gov Identifier NCT03464136
Drug: ustekinumab or adalimumab

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab (no placebo arm) in biologic naive participants with moderately-to-severely active Crohn’s disease.

Bergamot

ClinicalTrials.gov Identifier: NCT02394028
Drug: etrolizumab (anti-integrin β7), injection under the skin

This purpose of this Phase 3 study is to evaluate etrolizumab compared with placebo in subjects with moderate to severely active Crohn’s Disease.

Serenity

ClinicalTrials.gov Identifier: NCT02891226
Drug:  mirikizumab (IL-23), IV infusion and injection under the skin

The purpose of this Phase 2 study is to evaluate different doses of mirikizumab compared with placebo in subjects with active Crohn’s Disease.

Advance

ClinicalTrials.gov Identifier: NCT03105128
Drug:  risankuzumab (IL-23), IV infusion and injection under the skin

The purpose of this Phase 3 study is to evaluate risankizumab versus placebo in subjects with moderately to severely active Crohn’s disease.

Pizzicato

ClinicalTrials.gov Identifier: NCT03395184
Drug:  JAK3 vs JAK1/TYK2, oral medication

The purpose of this Phase 2 study is to evaluate a JAK3 vs JAK1/TYK2 vs placebo in subjects with moderately to severely active Crohn’s disease.

Dine-CD

ClinicalTrials.gov Identifier: NCT03058679

The purpose of this study is to compare the effectiveness of two dietary interventions for patients with Crohn’s disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD). The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.

Pioneer

ClinicalTrials.gov Identifier: NCT02793778

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 subjects receiving induction therapy for Remicade® or Humira®.   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

 

Ulcerative Colitis Treatment Studies

Laurel

ClinicalTrials.gov Identifier: NCT02165215
Drug: etrolizumab (anti-integrin β7), injection under the skin

The purpose of this Phase 3 study is to investigate etrolizumab vs placebo in subjects with moderately to severely active ulcerative colitis (UC) who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Hickory

ClinicalTrials.gov Identifier: NCT02100696
Drug: etrolizumab (anti-integrin β7), injection under the skin

The purpose of this Phase 3 study is to investigate etrolizumab vs placebo in subjects with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of TNF inhibitors.

 

Enrolling IBD Registry Studies

The purpose of registry studies, also known as Phase 4 trials, is to learn about the long-term safety and efficacy of medications.  Information is collected from patients during regularly scheduled clinic visits for a 5 to 10 year follow up period.  No additional visits or treatment are required.  Medications are not provided as part of the study.  For more information or to enroll in any of these registries, please call (919) 843-9071 or send an e-mail to ibdtrials@med.unc.edu.

IBD BIOME

This registry study includes patients with ulcerative colitis and Crohn’s disease.  In addition to brief interviews completed over the phone, patients are asked to collect and ship a stool sample four times over an 18-month period.  Family and friends of the patients with IBD are also asked to participate.

LEGACY

This registry study includes patients with ulcerative colitis who have been taking a stable dose of Humira, azathioprine (AZA) or 6-mercaptopurine (6-MP) for at least 8 weeks.

PASS

This registry study includes patients with ulcerative colitis and Crohn’s disease who are starting a new treatment of vedolizumab or another biologic therapy.

PIANO

This registry includes pregnant women who are taking IBD medications throughout their pregnancy.

VEDOLIZUMAB in BREASTMILK

This registry includes women who took vedolizumab during pregnancy and are breastfeeding their baby.