Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in... Read More
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
11/29/2023
Locations: Mid-Atlantic GI Research, LLC, Greenbelt, Maryland
Conditions: Ulcerative Colitis
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Recruiting
This study will investigate in patients with Crohn s disease and ulcerative colitis how the body s immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments. Patients between the ages of 0 and 75 years of age with Crohn s disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible fo... Read More
Gender:
All
Ages:
75 years and below
Trial Updated:
11/23/2023
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland
Conditions: Inflammatory Bowel Disease, Ulcerative Colitis, Chrohn's Disease
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
Recruiting
This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
11/16/2023
Locations: Charter Radiology, Columbia, Maryland +2 locations
Conditions: Ulcerative Colitis
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Recruiting
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
Gender:
All
Ages:
Between 16 years and 80 years
Trial Updated:
10/30/2023
Locations: Chevy Chase Endoscopy Center (Endoscopy Facility Only), Chevy Chase, Maryland +3 locations
Conditions: Ulcerative Colitis
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
Recruiting
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Gender:
All
Ages:
18 years and above
Trial Updated:
10/25/2023
Locations: Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland +2 locations
Conditions: Autoimmune Disease, Crohn Disease, Dermatomyositis, Inflammatory Bowel Disease, Multiple Sclerosis, Rheumatoid Arthritis, Sjogren Syndrome, Systemic Lupus Erythematosus, Systemic Scleroderma, Ulcerative Colitis, Hematopoietic and Lymphoid Cell Neoplasm, Psoriasis, Psoriatic Arthritis, Malignant Solid Neoplasm
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
Gender:
All
Ages:
18 years and above
Trial Updated:
10/18/2023
Locations: Chevy Chase Clinical Research, Chevy Chase, Maryland +2 locations
Conditions: Ulcerative Colitis, Ulcerative Colitis Chronic
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
Recruiting
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
09/01/2023
Locations: John Hopkins University, Columbia, Maryland
Conditions: Ulcerative Colitis
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
Recruiting
This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC. This study comprises 3 periods including screening period (D-28~D-1), treatment period (D1-D28), and safety follow-up period(D29-D58).
Gender:
All
Ages:
Between 18 years and 65 years
Trial Updated:
09/01/2023
Locations: Meridian Clinical Research, Rockville, Maryland
Conditions: Ulcerative Colitis
ABTECT - Maintenance
Recruiting
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
06/28/2023
Locations: University of Maryland Medical Center, Baltimore, Maryland
Conditions: Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
Recruiting
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
06/27/2023
Locations: University of Maryland Medical Center, Baltimore, Maryland
Conditions: Ulcerative Colitis
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
Recruiting
The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital... Read More
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
04/26/2023
Locations: University of Maryland School of Medicine, Baltimore, Maryland
Conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC)
Recruiting
Ulcerative colitis (UC) is a chronic, progressive immunologically mediated disease affecting nearly 1 million Americans. Up to one third of patients with UC will require hospitalization for severe disease (termed 'acute severe colitis (ASUC)'), often within the first year after diagnosis. Investigators will develop a large multi-center cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical and laboratory data.
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
01/04/2023
Locations: Joanna Melia, Baltimore, Maryland
Conditions: Ulcerative Colitis