A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
NCT05287126 · Ulcerative Colitis
RecruitingThe purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).
PhasePhase 2
TypeInterventional
Age12 Years – 17 Years
WhereLittle Rock, Arkansas, United States + 46 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
NCT03816345 · Autoimmune Disease, Crohn Disease, Dermatomyositis
RecruitingThis phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 51 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies
NCT07427017 · Ulcerative Colitis (UC)
RecruitingMicronutrient deficiencies are common in ulcerative colitis (UC). Selenium deficiency is associated with worse disease outcomes including disease flares and need for surgery. Previous in vitro and in vivo studies demonstrated that selenium regulates colonic inflammation, and that selenium supplementation protects against DSS-induced colitis. In this proof-of-concept clinical trial, we aim to test the hypothesis that selenium supplementation in moderate to severely active UC patients will improve responsiveness to advanced therapy such as biologics and small molecules.
PhasePhase 2
TypeInterventional
Age18 Years – 85 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
NCT07186101 · Ulcerative Colitis
RecruitingThe main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereScottsdale, Arizona, United States + 148 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
NCT06095128 · Ulcerative Colitis
RecruitingThe main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.
PhasePhase 4
TypeInterventional
Age18 Years – 65 Years
WhereDothan, Alabama, United States + 48 more
SponsorTakeda
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
NCT06598943 · Ulcerative Colitis, Ulcerative Colitis Chronic
RecruitingThe main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereChandler, Arizona, United States + 206 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
NCT05230173 · Ulcerative Colitis, Crohn Disease
RecruitingThe 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.
PhaseNA
TypeInterventional
Age18 Years
WhereIrvine, California, United States + 21 more
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
NCT06937086 · Ulcerative Colitis, Obesity or Overweight
RecruitingThe main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
PhasePhase 3
TypeInterventional
Age18 Years – 70 Years
WhereDothan, Alabama, United States + 190 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
NCT06693310 · Ulcerative Colitis (UC)
RecruitingThe goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes
PhaseNA
TypeInterventional
Age18 Years – 75 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
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