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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effectiveness and safety of oral AP1189 combined with methotrexate in adults with early rheumatoid arthritis who have not previously been treated with disease-modifying anti-rheumatic drugs DMARDs. This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 40, 70, or 100 mg impact disease activity and inflammation over 12 weeks in participants with active early rheumatoid arthritis. Participants will be randomly assigned to one of four groups, each receiving daily oral treatment for 12 weeks AP1189 at 40 mg, 70 mg, or 100 mg doses alongside methotrexate, or a placebo alongside methotrexate. The study compares the effects of these treatments on rheumatoid arthritis symptoms and inflammation to determine the best dose of AP1189 when combined with methotrexate. During the study, participants will attend scheduled visits for assessments including joint evaluations, blood tests for inflammation markers such as C-reactive protein CRP, and other safety monitoring. Researchers will measure changes in the Disease Activity Score 28 DAS28-CRP at 12 weeks to evaluate treatment impact. Participants will be monitored closely for safety and tolerability throughout the trial period, which lasts about 12 weeks.
Actively Recruiting
Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.
Actively Recruiting
Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.
Actively Recruiting
Researchers are evaluating KBP-336, a drug designed to treat knee pain caused by osteoarthritis in people who are also living with obesity. This Phase 2 clinical trial aims to find out if KBP-336 can reduce pain and body weight compared to a placebo, while also assessing its effects on quality of life, metabolism, and safety. The study is sponsored by KeyBioscience AG and focuses on adults aged 45 years and older with diagnosed osteoarthritis of the knee and obesity. Participants in this study will receive weekly subcutaneous injections of KBP-336 or a placebo for six months. The study compares multiple dosages of KBP-336 against placebo, with participants visiting the clinic every two weeks for checkups and tests. Throughout the trial, participants will maintain a diary recording their symptoms and use of any additional pain medications allowed as rescue treatment. During the study, participants will be regularly assessed using several tools, including the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC for pain, stiffness, and function, as well as quality of life questionnaires AQol 8D. Researchers will monitor changes in body weight, pain levels, body composition, bone density, and medication use over 183 days. Safety and well-being will be closely observed through physical exams, vital signs, ECGs, and lab tests, with the total trial duration lasting about six months for each participant.
Actively Recruiting
Researchers are studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.
Actively Recruiting
Researchers are evaluating sonelokimab in adults with active psoriatic arthritis who have not had adequate results or could not tolerate prior anti-tumor necrosis factor TNF alpha therapy. This Phase 3, multicenter, randomized, double-blind study compares the safety and effectiveness of two doses of sonelokimab against placebo and an active reference treatment called risankizumab. Participants are randomly assigned to one of four groups one receiving sonelokimab dose 1, another receiving sonelokimab dose 2, one receiving placebo, and one receiving risankizumab. Those in the sonelokimab groups receive four initial subcutaneous doses as induction, then maintenance doses every four weeks starting at Week 8. The placebo and risankizumab groups receive their respective treatments subcutaneously according to the study protocol. During the study, participants will undergo assessments of joint tenderness and swelling, skin psoriasis activity, physical function, and quality of life at Week 16. Researchers will monitor response rates based on improvement criteria such as the American College of Rheumatology 50% improvement ACR50. Safety and tolerability will also be followed throughout the trial, which is expected to complete by January 2027.
Actively Recruiting
This trial focuses on adults aged 64 and older who have moderate-to-severe primary knee osteoarthritis, a condition where joint cartilage breaks down and causes chronic inflammation and pain. The study evaluates the effects of Allocetra, an immunomodulatory cell-based therapy, compared to a placebo. Allocetra consists of specially modified allogeneic blood cells designed to reprogram immune cells and potentially reduce inflammation in the knee joint. Participants are randomly assigned to receive either Allocetra or a placebo through three ultrasound-guided injections into the affected knee on Days 0, 14, and 28. The study lasts for 12 months, with follow-up visits to monitor outcomes over this period. The trial is double-blind, meaning neither participants nor researchers know who receives Allocetra or placebo during the study. During the trial, participants will have assessments including pain and function evaluations using the Western Ontario and McMaster Universities Arthritis Index WOMAC at 3 and 6 months. Safety monitoring will continue for six months. Other measures such as quality of life and daily pain scores will also be collected. The study aims to understand Allocetras impact on knee osteoarthritis symptoms and safety over one year of observation.