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Physicians in the University of Maryland Medical Center's Inflammatory Bowel Disease (IBD) Program are actively involved in clinical research. View more information about current clinical trials or past publications.

Clinical Trials

The UMB IBD program is a member of the Clinical Research Alliance of the Crohn's and Colitis Foundation of America. Currently, the UM IBD program offers the following clinical research studies for patients to participate in:

Gene Discoveries in Subjects with Crohn's Disease of African Descent

The goal of this study is to perform genetic studies to better understand the differences between African Americans and Caucasians with inflammatory bowel disease.

  • Status: Recruiting
  • If you have any questions please contact the principal investigator, Dr. Raymond Cross, at 410-706-1 IBD (1423).

Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn's Disease.

The goal of this study is to compare the effectiveness of the Specific Carbohydrate Diet and a Mediterranean style diet to induce symptomatic and clinical remission in patients with active Crohn's disease.

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease.

The goal of this study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Crohn's disease (CD). This study will be enrolling patients who are biologic-naïve and biologic experienced patients.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

The goal of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula. This study is a Phase 2, double-blind, randomized, multicenter study.

TiGenix

A Phase 3 Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients with Crohn’s Disease Over a Period of 24 weeks and a Follow up Period up to 52 weeks
The purpose of this study is to evaluate the efficacy and safety of Adult Allogeneic Expanded Adipose-derived Stem Cells for treatment of complex perianal fistula(s). 

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The goal of this study is to evaluate the safety of different doses of ABT-494 and determine how well it works, as well as the pharmacokinetics (PK) (how drug is absorbed, distributed, and eliminated in the body over time) of ABT-494 in subjects with moderate to severe Ulcerative Colitis (UC).

Theravance 

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis

This set of studies is to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Lucent 1

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severe Active Ulcerative Colitis

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. 

  • Status: Recruiting

Learn more about clinical trial NCT03518086 on clinicaltrials.gov, or contact the principal investigator, Dr. Raymond Cross, at 410-706-1 IBD (1423).

Lucent 2

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance in Patients With Moderately to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086). 

HBO

Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized Trial
The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen in treatment of moderate to severe ulcerative colitis. 

MASCC

Multi-center Acute Severe Ulcerative Colitis Cohort Study 
The purpose of this study is to develop a large multi-center cohort of patients with acute severe ulcerative colitis with homogeneously collected detailed longitudinal clinical and laboratory data.

Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC-IBD)

This study goal is to create a longitudinally followed, well phenotyped cohort of patients with IBD who have linked clinical data, self-reported outcome data, and biosamples that can be used for clinical and translational research that will lead to precision medicine strategies and new therapeutic targets that will improve the quality of life of patients with IBD.

  • Status: Recruiting
  • To learn more, contact the principal investigator, Dr. Raymond Cross, at 410-706-1 IBD (1423).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC-1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis, True North Study.

The goals of this study are to see whether RPC1063 is safe and effective for the possible treatment of UC. To do this, a comparison will be made between patients who receive study drug and patients who receive placebo.

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

The primary objective of this Registry is to evaluate the long-term safety of HUMIRA® in moderately to severely active UC adult patients (18 years of age or older) who are treated per routine clinical practice.

Corrona Inflammatory Bowel Disease (IBD) Registry

The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD. The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC).

  • Status: Recruiting
  • Learn more about clinical trial NCT03162549 or contact the principal investigator, Dr. Sandra Quezada, at 410-706-1 IBD (1423).

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