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A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and
Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo
and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia
Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis

3. STUDY OBJECTIVES3.1. Primary ObjectivesThe primary objectives are:• To determine if CAEL-101 and treatment for PCD improves overall survival in Mayo stage IIIa AL amyloidosis patients who are treatment naïve compared to treatment for PCD alone•…

Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy

The primary objective of this study is to examine whether MIS is non-inferior to laparotomy in terms of disease free survival (DFS) in women with advanced stage EOC that received 3 to 4 cycles of NACT.

A PHASE IIIB, MULTICENTER, RANDOMIZED,
VISUAL ASSESSOR-MASKED STUDY OF THE
EFFECTIVENESS AND SAFETY OF A 36-WEEK
REFILL REGIMEN FOR THE PORT DELIVERY
SYSTEM WITH RANIBIZUMAB VS AFLIBERCEPT
TREAT & EXTEND IN SUBJECTS WITH
NEOVASCULAR AGE-RELATED MACULAR
DEGENERATION (DIAGRID)

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept…

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…

Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia

This study has been transitioned to CTIS with ID 2024-518855-43-00 check the CTIS register for the current data. Primary objective: To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic…

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

3. STUDY OBJECTIVES3.1. Primary ObjectivesThe primary objectives are:• To determine if CAEL-101 and treatment for PCD improves overall survival in Mayo stage IIIb AL amyloidosis patients who are treatment naïve compared to treatment for PCD alone•…

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…

DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients

The DAPARHT trial is designed to assess effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) weight, ii) glucose…

Long Term Follow Up Study for Participants of Kite Sponsored Interventional Studies Treated with Gene Modified Cells

This study has been transitioned to CTIS with ID 2023-507041-28-00 check the CTIS register for the current data. The primary objectives of this study are to:• Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious…

TOLERANCE: a 3 arm randomized study on healTh-related quality Of Life of EldeRly pAtients with advaNced soft tissue sarComa undergoing doxorubicin every three weeks or doxorubicin weekly or cyclophosphamide plus predniso(lo)ne treatment

Main objectiveThe primary objective of this study is to assess whether a higher HRQoL, in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide…

OPEN-LABEL PHASE 2/3 CLINICAL STUDY TO INVESTIGATE SAFETY AND IMMUNOGENICITY OF A SINGLE VLA2001 BOOSTER VACCINATION IN ADULT VOLUNTEERS, AFTER RECEIPT OF NATIONALLY ROLLED OUT MRNA COVID-19 VACCINES AND/OR NATURAL SARS-COV-2 INFECTION

Immunogenicity:To determine the immune response in terms of GMT fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001Safety:To assess tolerability of a VLA2001 booster vaccination

A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)

The primary objective of this study is to evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the distance walked (in meters) on the 6-minute walk test.The secondary objectives of this study are:- To evaluate the…

A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMER*S DISEASE

The primary objective of this secondary prevention study is to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of gantenerumab, an anti-amyloid antibody, in amyloid-positive, cognitively unimpaired participants at risk for or…

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis

This study has been transitioned to CTIS with ID 2023-506039-13-00 check the CTIS register for the current data. OBJECTIVESPrimary Objective• To assess the efficacy of efzofitimod in patients with pulmonary sarcoidosis Secondary Objectives• To…

IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002

The objective of the study is to establish the long-term safety and tolerability of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed.

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia

This study has been transitioned to CTIS with ID 2024-510696-38-00 check the CTIS register for the current data. Primary objective: To evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides from…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Primary:• To compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy as measured by…

IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo- Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction

This study has been transitioned to CTIS with ID 2024-514372-40-00 check the CTIS register for the current data. Primary objective: To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior…

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension
Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants with Active Systemic Lupus Erythematosus.

This study has been transitioned to CTIS with ID 2023-505635-13-00 check the CTIS register for the current data. The Primary Objective of this Clinical Trial is to evaluate the long-term safety and tolerability of litifilimab in participants with…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate
the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With
Moderately to Severely Active Crohn's Disease

Primary objective:- To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC inductionSecondary objectives:- To evaluate the efficacy of guselkumab SC across a range of outcome measures- To evaluate the safety…