A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
NCT07196722 · Crohn Disease
RecruitingThe purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 323 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
NCT07184931 · Crohn's Disease
RecruitingThis is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
PhasePhase 3
TypeInterventional
Age16 Years – 80 Years
WherePeoria, Arizona, United States + 129 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
NCT06937099 · Crohn's Disease, Obesity or Overweight
RecruitingThe main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.
PhasePhase 3
TypeInterventional
Age18 Years – 70 Years
WhereDothan, Alabama, United States + 186 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06029972 · Ulcerative Colitis
RecruitingThe goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereSun City, Arizona, United States + 128 more
SponsorGilead Sciences
▾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 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 A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
NCT06045754 · Crohn's Disease
RecruitingThe main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
PhasePhase 4
TypeInterventional
Age18 Years – 70 Years
WhereDothan, Alabama, United States + 53 more
SponsorTakeda
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
NCT07184996 · Ulcerative Colitis
RecruitingThis is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
PhasePhase 3
TypeInterventional
Age16 Years – 80 Years
WherePeoria, Arizona, United States + 139 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
NCT07196748 · Colitis, Ulcerative
RecruitingThe purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
PhasePhase 3
TypeInterventional
Age12 Years
WhereChandler, Arizona, United States + 366 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts