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Found 43 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the long-term safety and effectiveness of Afimkibart also known as RO7790121 in adults with Atopic Dermatitis who participated in earlier Afimkibart clinical trials. This Phase 2 extension study focuses on participants who previously responded to Afimkibart treatment, aiming to gather extended data over several years. Participants will receive Afimkibart through subcutaneous injections according to a schedule outlined in the study protocol. The study is non-randomized and involves parallel groups, with all participants receiving the active drug. The treatment and follow-up periods can last up to six years to assess long-term outcomes. Throughout the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment IGA, patient questionnaires on eczema symptoms and quality of life POEM and DLQI, and blood tests to measure drug levels and immune response. Researchers will monitor adverse events and antibody development against Afimkibart. Participation involves ongoing evaluations and monitoring over the extended study duration.

Age: 18Years +All GendersPhase 2
28 locations
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Actively Recruiting

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Age: 18Years +All GendersPhase 3
564 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Age: 18Years - 85YearsAll GendersPhase 2
225 locations
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Actively Recruiting

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Age: 12Years +All GendersPhase 3
400 locations
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Actively Recruiting

This research aims to evaluate the long-term safety and effectiveness of the drug baricitinib in treating juvenile idiopathic arthritis JIA in children and adolescents aged 1 to under 18 years. Participants in this study have previously taken part in other baricitinib studies for JIA. The purpose is to monitor how well baricitinib works and to assess any serious side effects over an extended period. Participants will receive baricitinib orally during the study. This is a single-group trial where all participants receive the same treatment. The study follows participants for a total duration of up to 264 weeks approximately 5 years, during which they will be monitored closely for safety and disease activity. Throughout the study, participants will have regular assessments including monitoring for serious adverse events and treatment discontinuations. Researchers will also evaluate disease activity, pain levels, and other health measures using various clinical tools at baseline and at the end of the study period. This long-term follow-up ensures thorough evaluation of baricitinibs impact and participant well-being.

Age: 1Year - 18YearsAll GendersPhase 3
78 locations
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Actively Recruiting

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Age: 18Years +All GendersPhase 2Phase 3
368 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of pirtobrutinib LOXO-305 compared to ibrutinib in participants with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study includes participants who may or may not have received prior treatment for their cancer. Part 1 of the trial lasts up to six years, while Part 2 focuses on treatment-nafve participants with a specific genetic deletion 17p deletion and lasts up to two years. Participants will receive pirtobrutinib or ibrutinib orally, depending on their assigned study group. Part 1 compares pirtobrutinib to ibrutinib in a randomized, open-label design. Part 2 evaluates pirtobrutinib alone in participants with the 17p deletion who have not yet been treated. Treatment continues until disease progression, unacceptable side effects, or other study-defined reasons. During the study, participants undergo regular assessments including clinical evaluations and monitoring of their response to treatment using established criteria. Researchers measure overall response rates, progression-free survival, event-free survival, duration of response, overall survival, time to next treatment, symptom worsening, and treatment tolerability. Participation involves ongoing monitoring for up to six years in Part 1 and two years in Part 2 to evaluate long-term outcomes and safety.

Age: 18Years +All GendersPhase 3
143 locations
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Actively Recruiting

Researchers are evaluating DMX-200 repagermanium, a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis FSGS who are also receiving an angiotensin II receptor blocker ARB. This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine proteincreatinine ratio and kidney function tests like estimated glomerular filtration rate eGFR at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.

Age: 12Years - 80YearsAll GendersPhase 3
220 locations
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Actively Recruiting

Researchers are evaluating whether combining vedolizumab and upadacitinib, called dual targeted therapy DTT, reduces bowel inflammation and ulcers more effectively than vedolizumab alone in adults with moderately to severely active Crohns Disease CD. The study also compares the safety and effectiveness of these treatments. This Phase 3b trial is conducted worldwide and sponsored by Takeda, enrolling about 396 participants. Participants are randomly assigned to receive either vedolizumab with upadacitinib or vedolizumab with a placebo for 12 weeks during the Induction Phase. Vedolizumab is given as a 300 mg intravenous infusion at Weeks 0, 2, 6, and 10 upadacitinib or placebo is taken daily by mouth. Those who respond to treatment at Week 12 will continue with vedolizumab alone every 8 weeks for 40 weeks in the Maintenance Phase. Vedolizumab dosing frequency may increase to every 4 weeks if needed. During the approximately 70-week study, participants visit the clinic 15 times for assessments including clinical evaluations, endoscopic exams, and patient-reported outcomes. Researchers measure clinical remission, endoscopic response, and safety outcomes at Week 12 and Week 52. There is also an 18-week safety follow-up after the maintenance period to monitor participants health.

Age: 18Years - 65YearsAll GendersPhase 3
138 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Age: 18Years - 75YearsAll GendersPhase 2
190 locations

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