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Found 17 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Age: 18Years +MALEPhase 3
291 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the safety, tolerability, and behavior in the body pharmacokineticspharmacodynamics of a drug called LY3962681 in both healthy volunteers and patients with Parkinsons disease. This study is divided into two parts the Single Ascending Dose SAD study involving healthy participants and the Multiple Ascending Dose MAD study involving Parkinsons patients. The study aims to understand how the drug works and how safe it is when given in different doses. In the SAD part, healthy volunteers will receive one dose of LY3962681 or a placebo injected into the spinal fluid. In the MAD part, Parkinsons patients will receive two doses of the drug or placebo, also injected into the spinal fluid, spaced 12 to 24 weeks apart. The SAD treatment lasts one day, while the MAD treatment includes two dosing days separated by a few months. Participants will be monitored for up to 52 weeks after their final dose. During this time, researchers will watch for any serious or new side effects, track how the drug moves and acts in the body, and measure changes in specific Parkinsons disease markers in spinal fluid. The study involves medical evaluations, cognitive tests, and safety monitoring throughout the follow-up period to ensure participant well-being.

Age: 30Years - 80YearsAll GendersPhase 1
4 locations
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Actively Recruiting

Researchers are evaluating whether donanemab slows the progression of cognitive decline, which affects thinking, learning, memory, attention, and decision-making, as well as functional decline impacting daily activities. This study focuses on adults aged 55 to 85 who have early cognitive decline along with Lewy Body Dementia features and confirmed brain amyloid and alpha-synuclein pathology. The trial is a phase 2 treatment study sponsored by Eli Lilly and Company, lasting one and a half years per participant. Participants are randomly assigned to receive either donanemab or a placebo, both given as intravenous infusions. Donanemab is being studied to assess its effects compared to placebo in this population. The treatment period lasts for 52 weeks, during which participants receive regular infusions under medical supervision. During the study, participants will undergo various assessments including cognitive and functional tests such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Integrated Alzheimers Disease Rating Scale iADRS, and Alzheimers Disease Assessment Scale - Cognitive Subscale ADAS-Cog13. Brain imaging and cerebrospinal fluid analysis will also be performed to measure amyloid plaque levels and alpha-synuclein pathology. Safety and drug levels in blood will be monitored throughout, with participants being followed closely for one and a half years total.

Age: 55Years - 85YearsAll GendersPhase 2
71 locations
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Actively Recruiting

Healthy Volunteer

This trial investigates the safety, tolerability, and how the body processes a drug called LY4006896 compared with a placebo in both healthy adults and adults with Parkinsons disease. The study is a phased clinical trial aiming to gather early evidence on these aspects for LY4006896, with participants including healthy individuals and those diagnosed with Parkinsons disease. Healthy participants will receive a single escalating intravenous dose of LY4006896 or a matching placebo, while participants with Parkinsons disease will receive multiple escalating intravenous doses or placebo. The study includes a screening period of up to 120 days for Parkinsons participants who get 4 doses, and up to 35 days for healthy participants who receive 1 dose. Treatment and follow-up last up to 61 weeks for Parkinsons participants and 48 weeks for healthy participants. Participants will undergo various assessments including monitoring for serious and treatment-emergent adverse events up to 48 weeks for healthy participants and 61 weeks for those with Parkinsons disease. Researchers will measure drug levels in the body and examine effects on alpha-synuclein protein in skin and cerebrospinal fluid. The total study duration can be up to 78 weeks for Parkinsons participants and 53 weeks for healthy participants, with ongoing safety and pharmacokinetic evaluations throughout.

Age: 30Years - 85YearsAll GendersPhase 1
14 locations
P

Actively Recruiting

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

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

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in adults aged 18 years and older with Primary Aldosteronism PA. This Phase III, global study involves approximately 250 participants and aims to reduce seated blood pressure and normalize the Renin Angiotensin Aldosterone System RAAS. Participants may have prior treatment with Mineralocorticoid Receptor Antagonists MRAs or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat or a matching placebo, both given orally once daily. The dose may be increased after two weeks depending on the participants clinical response and how well they tolerate the medication. The study is conducted across about 90 centers in 12 countries and involves parallel groups. Throughout the study, participants will have their seated systolic blood pressure and RAAS activity measured at week 8 to assess changes from baseline. Additional assessments include monitoring potassium levels, urine aldosterone, and albumin levels up to week 52. Safety and treatment effects will be regularly evaluated during visits. Total participation spans from screening through treatment and follow-up visits as scheduled.

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

Researchers are evaluating the use of oral ivosidenib in adults with locally advanced or metastatic conventional chondrosarcoma that has an IDH1 gene mutation. This Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study focuses on participants who have not had curative surgery and have experienced disease progression or recurrence. Participants may have had up to one prior systemic treatment for their advanced or metastatic chondrosarcoma. The study aims to measure progression-free survival as the primary outcome, especially in Grades 1 and 2 patients, along with overall survival and other efficacy and safety outcomes. Participants will be randomly assigned to receive either ivosidenib 500 mg orally once daily as two 250 mg tablets or a matching placebo. Treatment will continue until disease progression confirmed by blinded independent central review, unacceptable side effects, pregnancy, death, withdrawal, loss to follow-up, or study end, with an expected average treatment duration of about two years. Those on placebo who experience disease progression and meet criteria may cross over to receive ivosidenib. Throughout the study, participants will undergo regular imaging assessments to monitor tumor response using RECIST v1.1 criteria. Various patient-reported outcomes, adverse event monitoring, and laboratory tests including plasma ivosidenib and 2-hydroxyglutarate levels will be collected. The study includes follow-up for up to 5 years to evaluate long-term survival, disease control, and safety. The total participation duration varies depending on individual progression and study timelines.

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

Researchers are evaluating the efficacy and safety of mocravimod as an additional and maintenance treatment in adults with acute myeloid leukemia AML undergoing allogeneic hematopoietic cell transplantation HCT. This phase III, multicenter, randomized, double-blinded, placebo-controlled trial focuses on AML patients receiving stem cell transplants to assess relapse-free survival and overall survival outcomes. Participants will be assigned to one of three groups receiving either 3 mg or 1 mg of mocravimod orally once daily for 12 months, or a matching placebo orally once daily for the same duration. The study drugs are taken continuously over the one-year treatment period following transplantation, with the goal to evaluate mocravimod as a supportive therapy alongside standard care. During the study, participants will be monitored with regular clinical assessments, including evaluation of relapse-free survival at 12 months and overall survival at 24 months. Safety and efficacy will be closely observed through follow-up visits. The total participation duration spans at least one year of treatment plus extended survival monitoring, ensuring comprehensive data collection on the impact of mocravimod in this patient population.

Age: 18Years - 75YearsAll GendersPhase 3
111 locations
P

Actively Recruiting

This trial is studying participants with various types of tumors who are already being treated with the drug ONO-4538, either alone or combined with other therapies. The main goal is to confirm the long-term safety of ONO-4538 in these patients. The study is open-label and phase II, focusing on patients continuing treatment from previous clinical trials. Participants receive ONO-4538 through intravenous infusion, with doses of either 480 mg every 4 weeks or 240 mg every 2 weeks, as decided by the investigator. Some participants continue combination therapies alongside ONO-4538, including S-1 plus Oxaliplatin, Capecitabine plus Oxaliplatin, Bevacizumab, or Temozolomide, depending on their prior treatment in earlier studies. Throughout the study, patients are monitored for adverse events from the first day of treatment until 28 days after finishing the treatment phase. Researchers track safety by recording any side effects experienced. The study is non-randomized and open-label, and participants remain under medical supervision to assess how they tolerate the ongoing therapy over time.

Age: 16Years +All GendersPhase 2
38 locations
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Actively Recruiting

Healthy Volunteer

Pancreatic cancer is often diagnosed at an advanced stage, and there is no established effective population-based screening method. This study evaluates the Enzeavour Pancreatic Cancer assay, a blood test that measures three specific enzymes at a single-molecule level and combines four biomarkers into a composite Enzeavour Score. The trial is a nationwide, multicenter, prospective, single-arm feasibility study conducted in Japan, enrolling about 10,000 asymptomatic adults. Participants undergo the Enzeavour assay during routine health checkups or organized cancer screening visits. Those with an Enzeavour Score above 0.369 are referred for further diagnostic imaging, which may include MRCP, EUS, or contrast-enhanced CT based on clinical indications. This study uses a partial verification design with 12-month follow-up for specific subgroups to estimate pancreatic cancer detection rates and positive predictive value. Throughout the study, participants provide peripheral blood samples for the assay and may undergo diagnostic imaging if their test is positive. Researchers monitor pancreatic cancer detection within 12 months after the blood draw as the primary outcome and measure the positive predictive value of the assay as a secondary outcome. The study duration extends up to the end of 2028, with safety and diagnostic results followed during this period.

Age: 20Years +All GendersPhase Not Applicable
48 locations

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