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.

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.

Galaxi

ClinicalTrials.gov Identifier: NCT03466411
Drug:  Guselkumab (IL-23), IV infusion and injection under the skin; Ustekinumab (IL-12/IL-23), IV infusion and injection under the skin

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn’s disease.

Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease

ClinicalTrials.gov Identifier: NCT03451253

This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.

 

Ulcerative Colitis Treatment Studies

Lucent

ClinicalTrials.gov Identifier: NCT03518086
Drug:  Mirikizumab (IL-23), IV infusion and injection under the skin

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Eco-Reset

ClinicalTrials.gov Identifier: NCT0375C9041
Drug:  SER-287 (bacterial spores), oral medication

This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).

Optayil-1

ClinicalTrials.gov Identifier: NCT03482635
Drug:  Spesolimab, also known as BI 655130 (IL-36); IV infusion

The primary objectives of this trial are

  • to prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
  • to confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)

Vega

ClinicalTrials.gov Identifier: NCT03662542
Drug:  Guselkumab (IL-23) and Golimumab (Simponi); IV infusion and injection under the skin

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Vibrato

ClinicaTrials.gov Identifier: NCT02958865
Drug:  JAK3 vs JAK1/TYK2, oral medication

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

 

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.

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.

PIANO

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

TARGET-IBD

CliicalTrials.gov Identifier: NCT03251118

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

MAAIS– Multi-Center African-American Inflammatory Bowel Disease Study

ClinicalTrials.gov Identifier: NCT01169194

The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population.

TOUR

ClinicalTrials.gov Identifier: NCT03772145

The overarching goal of this study, is to create a longitudinally followed, well phenotyped cohort of patients with UC starting treatment with tofacitinib in the setting of standard of care who have linked clinical data and self-reported outcome data that will lead to evaluation of efficacy and safety of tofacitinib in the real-life setting