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Found 145 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Age: 18Years - 75YearsAll GendersPhase 2
71 locations
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Actively Recruiting

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Age: 18Years +All GendersPhase 1Phase 2
27 locations
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Actively Recruiting

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

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

Researchers are evaluating the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

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

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Age: 50Years - 80YearsAll GendersPhase 2
140 locations
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Actively Recruiting

This research aims to observe the long-term safety of efgartigimod treatment in adults with generalized myasthenia gravis gMG. It compares patients who are starting or have recently started efgartigimod treatment with those who have not been exposed to efgartigimod and are receiving other standard treatments. The study is non-interventional and prospective, focusing on real-world safety outcomes over an extended period. Participants are divided into two groups one receiving efgartigimod and another receiving other medications for myasthenia gravis. This study does not involve any new treatments being administered as part of the trial but monitors patients during their routine care. The study will continue for up to 10 years to gather long-term safety data. During the study, researchers will track the occurrence of serious infections and other safety concerns in both groups. Patients will be monitored through their regular clinical visits without additional interventions from the study. Participants may be followed for up to 10 years to assess safety outcomes associated with their treatments in everyday medical practice.

Age: 18Years +All Genders
35 locations
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Actively Recruiting

Researchers are evaluating IM-101 in adults with generalized myasthenia gravis gMG and ocular myasthenia gravis oMG, focusing on those with acetylcholine receptor AChR antibody-positive and AChR antibody-negative forms. The goal is to assess the safety, tolerability, how the drug moves through and affects the body, and the potential effectiveness of IM-101. This Phase 1b2 trial is sponsored by ImmunAbs Inc. and includes multiple study parts to explore these aspects thoroughly. Participants will receive IM-101 or a placebo through intravenous infusions. In Part A, participants get a loading dose on Day 1 and Day 15, followed by a maintenance dose on Day 29, with doses escalating across cohorts. In Part B, dosing includes loading doses on Day 1 and Day 15 and maintenance doses on Days 29, 57, and 85. Some may receive additional doses depending on decisions by an independent data monitoring committee. The study uses randomized, double-blind assignments to compare different dose levels and placebo effects. During the study, participants will be monitored for side effects and safety up to about 99 days in Part A and 169 days in Part B. Researchers will assess the impact of treatment on daily living activities and specific myasthenia gravis severity scores at baseline and Week 16. Safety assessments include tracking adverse events, serious adverse events, and events leading to discontinuation. Participants will undergo regular evaluations to measure the pharmacokinetics and pharmacodynamics of IM-101, with follow-up visits scheduled according to the dosing timeline.

Age: 18Years - 74YearsAll GendersPhase 1Phase 2
25 locations
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Actively Recruiting

Researchers are evaluating NEU-411 in adults aged 40 to 80 years who have early Parkinsons Disease PD with elevated activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 study aims to assess the safety and effectiveness of NEU-411, a selective brain-penetrant inhibitor of LRRK2, compared to placebo in participants with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411 at 30 mg once daily or a matching placebo for a 52-week treatment period. After this phase, participants may join an open-label extension to receive NEU-411 treatment for an additional 26 weeks. The study evaluates treatment effects on PD symptoms and adverse events. During the study, participants will undergo assessments including the Roche digital biomarker score using a Parkinsons Disease application and the Movement Disorder Societys Unified Parkinsons Disease Rating Scale. Safety monitoring includes tracking treatment-emergent and serious adverse events, with a follow-up visit scheduled within two weeks after treatment ends. Total study participation may extend up to 78 weeks including the extension phase.

Age: 40Years - 80YearsAll GendersPhase 2
70 locations
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Actively Recruiting

Researchers are evaluating the pharmacodynamic effect, safety, and tolerability of Povetacicept in adults with generalized myasthenia gravis gMG. This phase 2 study focuses on participants aged 18 to 80 years who have generalized muscle weakness and fall within the MGFA clinical classification II-IV. The study aims to better understand how Povetacicept affects immunoglobulin levels and the safety profile in this population. Participants will be randomly assigned to receive one of two doses of Povetacicept or a placebo via subcutaneous injection for the initial 12 weeks. Those who are eligible may continue treatment with Povetacicept for an additional 96 weeks in a long-term extension phase. This study uses a double-blind, placebo-controlled design to evaluate the treatment over a total period of up to 108 weeks. During the study, participants will undergo evaluations of immunoglobulin G levels at baseline and week 12. Safety and tolerability will be monitored throughout the entire treatment period by tracking adverse and serious adverse events. The study includes regular assessments to measure outcomes and monitor participant health, with the goal of completing by March 2029.

Age: 18Years - 80YearsAll GendersPhase 2
26 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of intravenously administered YN001 in adults diagnosed with coronary atherosclerosis who are also receiving background therapy for managing cardiovascular risk factors. This multinational, multicenter, phase 2b clinical trial is randomized, double-blind, and placebo-controlled to compare YN001 with placebo in this patient population. Participants will be randomly assigned to receive one of three doses of YN001 or matching placebo intravenously once weekly for 13 weeks. The doses include 40mg, 20mg, or 0mg placebo. The study consists of up to a 12-week screening and baseline period, a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up extending to approximately two years after randomization. During the study, participants will undergo various assessments including imaging to measure changes in coronary non-calcified plaque volume, carotid intima-media thickness, and plaque characteristics at multiple time points. Safety and immunogenicity will be monitored alongside pharmacokinetic analyses. The primary outcome focuses on relative change in coronary NCPV at week 13. Participants will be followed for up to 96 weeks to evaluate major adverse cardiac events and long-term safety.

Age: 18Years - 80YearsAll GendersPhase 2
28 locations

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