This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Type: Interventional

Start Date: Apr 2025

open study

This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.

Type: Interventional

Start Date: Aug 2025

open study

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month. In the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.

Type: Interventional

Start Date: Jul 2025

open study

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease. The main question that researchers want to answer is: - How many participants achieve a complete response after 104 weeks of treatment? - A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable. Researchers will also learn about: - How long it takes before the participants' disease gets worse - How long the participants' urine protein levels stay low - How many participants develop antibodies against felzartamab in the blood? - How many participants achieve a complete response after 76 weeks of treatment - How many participants have medical problems during the study - How felzartamab is processed by the body - How felzartamab affects participants' tiredness and overall physical health The study will be done as follows: - Participants will be screened to check if they can join the study. This may take up to 42 days. - Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets. - If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment. - If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104. - In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Type: Interventional

Start Date: May 2025

open study

The purpose of the project is to assess the efficacy of parietal transcranial magnetic stimulation in misophonia. N=60 participants will undergo two transcranial magnetic stimulation sessions: one inhibitory and another excitatory. During both sessions, the parietal region will be stimulated. Participants will perform computerized tasks immediately before and after the stimulation, while EEG, heart rate, and skin temperature will be recorded. These recordings will be used to assess if TMS can be used to improve tolerance to misophonia triggers.

Type: Interventional

Start Date: Sep 2025

open study

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Type: Interventional

Start Date: May 2025

open study

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease. - This study is seeking for participants who: Are willing to take all the required eye tests - Have not received TIVDAK before - Do not have any active eye issues. Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages: - before starting the treatment, - before each of the first 9 infusions - then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.

Type: Interventional

Start Date: May 2025

open study

This clinical trial evaluates the how well a virtually delivered solution-focused brief therapy (SFBT-C) works to decrease adolescent and young adult cancer survivors' psychological distress in comparison to enhanced treatment-as-usual care. Cancer and its treatment can have immediate and long-term impacts on adolescent and young adult cancer survivor's lives, including education and employment, financial stability, sexual health, and social, romantic, and family relationships. Consequently, many adolescent and young adult cancer survivors report psychological distress, often manifesting as depression and anxiety, and may benefit from psychotherapy to improve their engagement with medical treatment and overall quality of life. SFBT-C is a theory-driven and brief hope-based psychotherapy designed for the unique psychosocial needs facing adolescent and young adult cancer survivors. Undergoing SFBT-C may work better than treatment-as-usual care for the support of psychological distress in adolescent and young adult cancer survivors.

Type: Interventional

Start Date: Jun 2025

open study

This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).

Type: Interventional

Start Date: Jul 2025

open study

The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity. The main question it aims to answer is: Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance? Participants will: Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet. Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.

Type: Interventional

Start Date: Feb 2026

open study

The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period. Additional follow-up visits may be required up to 12 months from study start. - Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2). - Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.

Type: Interventional

Start Date: May 2025

open study

This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.

Type: Interventional

Start Date: Jul 2025

open study

Osteoarthritis (OA) is a major public health problem, and involvement of the knee is especially disabling. Symptomatic knee OA has an incidence rate between 40 to 1,020 per 100,000 person years1 and is among the most common causes of disability worldwide. Knee arthritis pain and disability are highly comorbid wiht depression (30-50%). Currently available treatments offer only limited relief. The Pilot project aims to establish feasibility of the rTMS neuromodulation of response to Tai Chi and improvement in pain and comorbid depression in patients with knee OA. There are several ways in which the pilot project will improve scientific knowledge, and clinical practice: 1) The sequential stimulation of two targets (M1 and l-DLPFC) has not been systematically examined for the treatment of comorbid MDD and knee OA. We hypothesize that using a multi-target rTMS strategy combining M1 and l-DLPFC- active targets will be well tolerated and more effective to treat comorbid symptoms than single site rTMS to M1+l-DLPFCsham. This hypothesis will be tested in Aim 1 of this proposal by comparing two experimental conditions: A) M1active and l-DLPFCactive; and B) M1active and l-DLPFCsham. 2) Identifying the relationship between improvement in pain and depression to improvement in pro-inflammatory cytokines would be novel. Adding an rTMS as a neuromodulation technique with novel stimulation sites to assist in the reduction of symptoms of pain and depression is another scalable to clinical use opportunity that will provide pilot data for future clinical trials. We will perform a pilot feasibility trial of rTMS for those presenting with knee osteoarthritis related pain and moderate to severe depression in 30 volunteers who are undergoing Tai Chi intervention. Tolerability and safety of rTMS added to Tai Chi will be assessed along with changes in symptoms of pain and depression, in preparation to future R-01 applications.

Type: Interventional

Start Date: Jun 2026

open study

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.

Type: Interventional

Start Date: Apr 2025

open study

The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are - What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? - Do patients report higher birth satisfaction with use of AID systems during labor/delivery? - Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery? Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.

Type: Interventional

Start Date: Dec 2025

open study

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Type: Interventional

Start Date: May 2025

open study

To collect data and samples from participants with cancer who also have invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection.

Type: Observational

Start Date: Oct 2025

open study

The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart/kidney transplantation.

Type: Interventional

Start Date: Apr 2025

open study

This is a Phase 1, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic Solid Tumors

Type: Interventional

Start Date: Mar 2025

open study

The goal of this pilot randomized clinical trial is to learn if Neurobehavioral Therapy (NBT) works to treat motor functional neurological disorder (mFND) (also referred to as functional motor disorder). The main questions it aims to answer are: - Does NBT lower mFND symptoms? - Does NBT lower common co-occurring symptoms and improve functioning? Researchers will compare NBT to standard medical care (SMC). Participants will be randomized to receive either: - 12 weekly sessions of NBT, along with their SMC, - or continue receiving their SMC as provided by their treating clinicians. - all participants. regardless of group assignment, will complete a total of five in-clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months for self-report surveys to assess functional status, quality of life and mFND symptoms.

Type: Interventional

Start Date: Sep 2024

open study

This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.

Type: Interventional

Start Date: Apr 2025

open study

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Type: Interventional

Start Date: May 2025

open study

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

Type: Interventional

Start Date: Feb 2025

open study

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or [177Lu]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Type: Interventional

Start Date: Jul 2025

open study