A PHASE II TRIAL EVALUATING THE SAFETY AND EFFICACY OF MR-LINAC- GUIDED RADIOTHERAPY AS SALVAGE TREATMENT AFTER EXTERNAL BEAM RADIOTHERAPY RECURRENCE (TUMORNATOR II)
This Phase 2 study is testing how using a special imaging technique called the Elekta Unity MR-linac system can be safe and effective for patients with prostate cancer that has not spread to other parts of the body after previous treatment with radiotherapy. Patients will have special scans taken before the study treatment to help the study team determine the treatment planning and doses. All patients will then be treated using an MR-guided approach on the Elekta Unity MR-linac system. The study team will collect tissue samples from all patients after treatment to see how the treatment is changing the tumor. All patients will have special scans taken and the study doctor will examine them to see how the patients are doing. All patients will be closely monitored for side effects and safety and followed every 6 months for up to 2 years after their treatment.
A Phase II/III Multicenter Randomized Double-Blind Placebo-Controlled Two-Part Adaptive Design Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer s Disease
Remternetug is an investigational drug, currently being studied to treat Alzheimer's Disease (AD).The purpose of this study is to determine if remternetug has favorable effects that may prevent or reduce the AD disease in the brain and prevent or delay AD symptoms, participants will have brain scans, blood and spinal fluid collected (for biomarkers, the tests that indicate progress of disease and response to study treatment), and tests of memory and thinking. This study will consist of 2 stages, which could last up to 9 years and will involve about 50 visits (30 visits in Stage 1, 20 visits in Stage 2).
A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?
A Phase III Multi-center Open-label Sponsor-blinded Randomized Study of AZD0901 Monotherapy Compared with Investigator s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
This study is designed to test how effective a new treatment called AZD0901 is for patients with advanced stomach cancer or cancer that is at the junction of the stomach and esophagus (GEJ) that shows a specific marker called CLDN18.2. In this study, patients will be divided into three groups. One group will receive AZD0901 and the other group will get a treatment chosen by their doctor from a list of commonly used cancer therapies. Patients will continue with their treatment until it is no longer effective or safe for them.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY SAFETY PHARMACOKINETICS AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI-N-METHYL-D-ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI-LEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) ENCEPHALITIS
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis.Current treatment of these disorders exclusively use off-label immune therapies and is based on expert opinion, retrospective case series, and open-label studies. Several unmet needs exist, including the frequent occurrence of long-term cognitive deficits, insufficient seizure control, frequent dependence on high-dose corticosteroids, and faster-acting but durable immunotherapy. There is a need for prospectively generated evidence-based treatments to meaningfully lessen the acute and long-term consequences of these disorders.
A Phase III Randomized Double-Blind Placebo-Controlled Multicenter Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS
This is a parallel-group, double-blind, randomized, placebo-controlled study comparingthe efficacy and safety of obinutuzumab versus placebo among patients with ISN/RPS2003 Class III or IV LN treated with standard-of-care therapy with MMF andcorticosteroids. The study will enroll approximately 252 patients.Patients must be 18?75 years of age and have ISN/RPS Class III or IV proliferative LNas evidenced by renal biopsy performed in the 6 months prior to screening or duringscreening. Patients may have concomitant Class V disease (i.e., Class III/V orClass IV/V). Patients must exhibit significant proteinuria as evidenced by a UPCR ? 1based on a 24-hour urine collection during screening.Key exclusion criteria include evidence of severe renal impairment, defined by an eGFR? 30 mL/min per 1.73 m2 of body surface area or ESRD requiring dialysis ortransplantation; evidence of active infection; and other safety-related exclusions.The study consists of the following study periods: screening, blinded treatment,open-label treatment (OLT), and study follow-up.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY SAFETY PHARMACOKINETICS AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)
This Phase III, randomized, double-blind (DB), placebo-controlled, multicenter study isdesigned to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics ofsatralizumab compared with placebo as monotherapy or in addition (add-on) tobaseline/background ISTs for MOGAD relapse prevention.The study will include a screening period of up to 28 days, an event-driven DB treatment period, and an approximately 2-year open-label extension (OLE) period.
A Phase III Randomized Double-blind Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes Carrying the Genetic HLA DR3-DQ2 Haplotype
The purpose of this study is to test the safety and effectiveness of an investigational drug called Diamyd®. Diamyd® is considered “investigational” in this research study, because it has not been approved for treatment of type 1 diabetes by regulatory authorities in any country, including the Food and Drug Administration (FDA) in the United States. It is hoped that Diamyd® will help the body preserve its ability to produce insulin by stopping or delaying the immune system’s attack on beta cells. In order to determine if Diamyd® is effective, a comparison must be made between Diamyd® and placebo. A placebo does not contain any active ingredient. Researchers use a placebo to see if a study drug works better or is safer than not taking anything at all.
A Phase III Randomized Double-Blind Placebo-Controlled Non-Inferiority Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
This study aims to develop evidence-based protocols for managing older patients with systemic lupus erythematosus (SLE), a topic that has been largely overlooked. Hydroxychloroquine (HCQ) is an effective medication for SLE, helping to reduce disease activity and keep symptoms stable. While HCQ is generally safer than traditional immunosuppressants regarding infections, long-term use can lead to retinal toxicity, with studies showing that nearly a third of patients may experience retinal damage. As lupus patients live longer, they may develop other health issues that affect how HCQ is processed in the body, potentially increasing the risk of toxicity compared to its benefits. Given that disease activity often decreases with age, this study will investigate whether HCQ can be safely stopped in stable patients aged 60 and older. Participants will be randomly assigned to receive either a placebo or continue with HCQ and will be monitored every two months for one year to track disease activity and flares.