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Ulcerative Colitis clinical trials at UCSD

12 in progress, 3 open to eligible people

Showing trials for
  • Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients

    open to eligible people ages 18-80

    Approximately 20-40% of patients with ulcerative colitis (UC) are obese. The investigators have demonstrated that obesity adversely impacts disease course in patients with UC, leading to higher risk of persistently active disease, surgery, hospitalization, and treatment failure, particularly in biologic-treated patients. Intentional weight loss is effective in improving disease outcomes in patients with inflammatory arthritis, but there is limited data on its impact in UC. While dietary interventions for weight loss have limited efficacy and endoscopic bariatric interventions may be too invasive in patients with UC with active gastrointestinal symptoms, pharmacological weight loss with a highly effective oral agent may be a novel strategy to induce weight loss and augment the efficacy of biologic therapy in UC. Hence, the investigators are conducting a pilot, phase 2A, 22-week, randomized, placebo-controlled clinical trial of phentermine-topiramate in obese patients with active UC starting on a new biologic agent (infliximab, adalimumab, golimumab, vedolizumab). The overall objective is to (1) evaluate the efficacy, safety and tolerability of phentermine-topiramate, and (2) to assess the impact of pharmacological weight loss on clinical outcomes, inflammatory burden and biologic trough concentration in patients with UC. The central hypothesis is that phentermine-topiramate will be safe, effective, and well tolerated in patients with UC, and weight loss would achieve higher rates of clinical and biochemical remission, and higher biologic trough concentration.

    La Jolla, California

  • Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission

    open to eligible people ages 18-80

    The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis [UC]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.

    La Jolla, California and other locations

  • Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

    open to eligible people ages 18 years and up

    The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are: 1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration. 2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity. Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod. Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.

    San Diego, California

  • Risankizumab in Participants With Ulcerative Colitis

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

    La Jolla, California and other locations

  • Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

    Sorry, in progress, not accepting new patients

    This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

    La Jolla, California and other locations

  • ABTECT - Maintenance

    Sorry, not currently recruiting here

    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, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

    La Jolla, California and other locations

  • ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

    Sorry, not currently recruiting here

    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, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

    La Jolla, California and other locations

  • Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

    Sorry, not currently recruiting here

    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]).

    La Jolla, California and other locations

  • Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

    Sorry, in progress, not accepting new patients

    The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

    La Jolla, California and other locations

  • Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

    Sorry, in progress, not accepting new patients

    This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

    La Jolla, California and other locations

  • Improving the Quality of Care for Adults With Inflammatory Bowel Disease

    Sorry, accepting new patients by invitation only

    Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.

    San Diego, California and other locations

  • IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

    Sorry, in progress, not accepting new patients

    This is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with Acute Severe Ulcerative Colitis.

    San Diego, California and other locations

Our lead scientists for Ulcerative Colitis research studies include .

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