Clinical Trials (Adult)

TAK-755-2001

A phase 2b, multicenter, randomized, double-blind study of safety and efficacy of TAK-755 (rADAMTS13) with minimal to no plasma exchange (PEX) in the treatment of immune mediated thrombotic thrombocytopenic purpura (iTTP).

The purpose of this study is to evaluate the safety and efficacy of the drug TAK-755 for patients with immune mediated thrombotic thrombocytopenic purpura (iTTP). iTTP is a rare life-threatening disorder caused by autoantibodies. TAK-755 is the first recombinant ADAMTS13 and can provide a more targeted therapy for iTTP

Principle Investigator: Ashwin A. Sridharan, MD

Sponsor: Takeda Development

Call 732-235-6132 or visit: https://www.clinicaltrials.gov/study/NCT05714969 for more information.

LIBREXIA-STROKE JNJ-70033093

A phase 3, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of milvexian, an oral factor Xia inhibitor, for after an acute ischemic stroke or high-risk transient ischemic attack.

Patients who have had a previous stroke or high risk transient ischemic attack are at a higher risk for another stroke. Many patients are started on blood thinner for prevention. However, all blood thinners are associated with a higher risk of bleeding. This trial evaluates the medication milvexian to prevent stroke in these patients. Milvexian is a new blood thinner that is associated with less risk of bleeding than the available options.

Principle Investigator: Roger Cheng, MD

Sponsor: Janssen Research and Development

Call 732-235-6132 or visit: https://www.clinicaltrials.gov/study/NCT05702034 for more information.

Melatonin A3 study

Melatonin for the prevention of antibiotic associated acute kidney injury.

The purpose of this trial is to evaluate the role of melatonin in preventing acute kidney injury in hospitalized patients started on vancomycin. Vancomycin is an antibiotic used to treat resistant bacteria however it can cause injury to the kidneys. Melatonin is a naturally occurring compound in the body that has a possible association with preventing that kidney injury.

Principle Investigator: Luigi Brunetti

Sponsor: NIH

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05084196 for more information.

ENGAGE-E-001 (StATES)

A double blind, randomized, placebo-controlled, multi-center, outpatient, parallel-group study to assess the efficacy and safety of staccato alprazolam in study participants 12 years of age and older with stereotypical prolonged seizures And An open-label, multicenter, outpatient extension study to evaluate the safety and tolerability of staccato alprazolam in study participants 12 years of age and older with stereotypical prolonged seizures.

This research will explore how effective and safe a one-time use of Staccato alprazolam is in treating seizures in an outpatient setting. One challenge in treating a seizure is the medication must be administered in a method that is readily absorbed and will act quickly. Staccato alprazolam is a new formulation that delivers alprazolam through inhalation and has an onset of action similar intravenous medications. After participating in this, subject may be able to join the open label study. This will allow for long term intermittent treatment with the staccato alprazolam inhaler.

Principle Investigator: Ram Mani, MD

Sponsor: UCB Pharma

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05077904 for more information.

ATHENA-SSc-ILD

A phase 2/3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD).

This study is set up to examine how effective and safe belimumab is in treating patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). SSc-ILD is a chronic lung disease that causes scar tissue to build up in the lungs. Belimumab may help patient’s lung function, general symptoms such as fatigue, and overall improve patient’s quality of life.

Principle Investigator: Vivien M. Hsu, MD

Sponsor: GlaxoSmithKline

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05878717 for more information.

Latent TB in ESRD

One-month latent tuberculosis (TB) treatment for renal transplant candidates

The purpose of this trial is to determine the safety of a month course of  isoniazid and rifapentine among patients with Latent TB before kidney transplant. A kidney transplant requires the patient to take medication to suppress their immune system, which can cause latent TB to be reactivated. Currently patients require several months of treatment before they can receive a kidney transplant. This study will evaluate if a one-month course of treatment is sufficient.

Principle Investigator: Pinki J. Bhatt, MD

Sponsor: Investigator initiated

Call 732-235-6132 or visit: https://www.clinicaltrials.gov/study/NCT05411744 for more information.

EVOID-AS – Cardiology

An adaptive phase 2/3 multicenter, double-blind, placebo controlled, randomized, parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 (evogliptin) in patients with calcific aortic valve disease with mild to moderate aortic stenosis

Calcific aortic stenosis is a common heart valve disorder caused by a build-up of calcium in the aortic valve. It may increase the risk of heart failure and other cardiac diseases. The study’s goal is to evaluate the safety and efficacy of evogliptin in patients with calcific aortic valve disease with aortic stenosis. Studies have shown that an enzyme called dipeptidyl peptidase-4 (DPP-4) may contribute to aortic valve calcification. Evogliptin is a DPP-4 inhibitor and may be useful in treating these patients.

Principle Investigator: Partho P. Sengupta, MD

Sponsor: Rednvia Co, LTD

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05143177 for more information.

VICTORION-2 PREVENT

A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease

High LDL cholesterol is considered a risk factor for heart disease. The main goal of this study is to show that inclisiran is more effective than a placebo in lowering the risk of cardiovascular death in patients who have both cardiovascular disease and high cholesterol levels. Inclisiran is a first in class small interfering RNA medication that lowers cholesterol.

Principle Investigator: Tudor Vagaonescu, MD

Sponsor: Novartis

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05030428 for more information.

EMERALD-2 MORF-057-202

A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adults with moderately to severely active ulcerative colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disorder characterized by bloody diarrhea, abdominal pain, and cramping. The goal of this study is to determine how well the oral drug, MORF-057 works for patients with moderately to severely active UC. MORF-057 is a first-in-class oral-available targeted treatment currently being researched for inflammatory bowel disease. Patients can be included in this study if they have shown an inadequate response to other first-line treatments of ulcerative colitis.

Principle Investigator: Darren Seril, MD

Sponsor: Morphic Therapeutic Inc

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05611671 for more information.

EXHALE-2

A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma

Asthma is common chronic airway disease characterized by inflammation of the airway causing difficulty breathing. One of the most severe and difficult to treat forms of asthma is eosinophilic asthma, where increases levels in eosinophils in the airway cause inflammation and tissue damage. Dexpramipexole is a tablet that can help decrease the level of eosinophils. This study will compare different doses of dexpramipexole with a placebo to evaluate its safety and effectiveness.

Principle Investigator: Reynold Panettieri, MD

Sponsor: Areteia Therapeutics

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05763121 for more information.

DigniFI

A Two-Stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel with Placebo in the Treatment of Female Participants with Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)

This study is evaluating the safety and effectiveness of iltamiocel in women suffering from chronic fecal incontinence due to obstetrical injury of the anal sphincter. Fecal incontinence due to an obstetrical injury can be a life altering problem and currently has limited treatment options. Iltamiocel is an investigational cell therapy that is made from the participant’s own muscle cells to strengthen the anal sphincter to help treat the fecal incontinence.

Principle Investigator: Juana Hutchinson-Colas

Sponsor: Cook MyoSite

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05776277 for more information.

APPELHUS (CLNP023F12301)

A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral twice daily LNP023 (iptacopan) in adult aHUS patients who are naïve to complement inhibitor therapy

The purpose of this study is to determine if iptacopan is both safe and effective in treating adult patients with atypical hemolytic uremic syndrome (aHUS) who have not previously received complement inhibitor therapy. aHUS is a rare potentially life-threatening disorder that causes small blood clots and organ damage. Iptacopan is an oral medication that acts on the complement pathway. This study will evaluate how iptacopan affects the blood and kidneys.

Principle Investigator: Ashwin A. Sridharan, MD

Sponsor: Novartis

Call 732-235-6132 or visit: https://www.clinicaltrials.gov/study/NCT04889430 for more information.

Olorofim Aspergillus Infection Study (OASIS)

A phase 3, adjudicator-blinded, randomized study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome followed by standard of care in patients with invasive fungal disease (IFD) caused by Aspergillus species

This study compares olorofim to AmBisome® + standard of care treatment for patients that have fungal infections caused by aspergillus. The study will compare mortality rates between the two groups after treatment. Invasive fungal infections can be life threatening and typically require intravenous treatment. Olorofim is an oral antifungal with a novel mechanism of action that may be a new treatment option.

Principle Investigator: Anjali Majumdar, MD

Sponsor: F2G Biotech

Call 732-235-6132 or visit: https://clinicaltrials.gov/study/NCT05101187 for more information.