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Clinical Trials

Clinical Trials

We have an unwavering commitment to improving care for patients with serious medical conditions through ongoing clinical development programs.

To learn more about clinical trials that are currently underway and to find out if a study is enrolling patients in your area or with your condition, please visit www.clinicaltrials.gov.

The results of certain applicable Jazz clinical trials are also available at www.clinicaltrials.gov.

As part of Jazz’s commitment to putting patients first, we are providing plain language summaries for certain clinical trials. These plain language summaries provide clinical trial results in an easy-to-understand format so all patients can obtain more information on the study results. Learn more about our study results.

Oncology

Study Evaluating Zanidatamab as First-Line Treatment in Advanced/ Metastatic HER2-Positive Gastroesophageal Adenocarcinomas (GEAs)

HERIZON-GEA-01 is a global, randomized, open-label Phase III study to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy with or without tislelizumab to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for patients with advanced/metastatic human epidermal growth factor receptor 2 (HER2) positive gastroesophageal adenocarcinomas (GEAs). This study is being conducted to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. Recruitment for the study will occur at approximately 300 trial sites in more than 30 countries, and is designed to have approximately 900 adult patients with HER2-positive gastroesophageal cancer participate. For more information about this study and participating sites, visit clinicaltrials.gov (and search “NCT05152147” or click here), or email clinicaltrialdisclosure@jazzpharma.com.

Study Evaluating Zanidatamab as First-Line Treatment in Advanced/Metastatic HER2-Positive Biliary Tract Cancer (BTC)

HERIZON-BTC-302 is a global, open-label, randomized Phase III study to evaluate the efficacy and safety of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer (BTC). The primary objective of the study is to compare the effi­cacy of zanidatamab and CisGem (cisplatin plus gemcitabine) with or without the addition of a programmed death protein 1/ligand 1 (PD-1/L-1) inhibitor versus CisGem with or without a PD-1/L1 inhibitor in adult participants. The study population eligible for this study are patients ≥18 years of age with locally advanced unresectable or metastatic HER2-positive BTC (gallbladder cancer or cholangiocarcinoma) and not eligible for curative resection, transplantation, or ablative therapies, and who have not had any therapy or who have just started therapy. For more information about this study and participating sites, visit clinicaltrials.gov (and search “NCT06282575” or click here), or email clinicaltrialdisclosure@jazzpharma.com.

Study Evaluating Lurbinectedin in Combination with a PD-L1 Inhibitor as a First Line Treatment for Extensive-Stage Small Cell Lung Cancer

IMforte is a Phase 3 clinical trial evaluating lurbinectedin in combination with the PD-L1 inhibitor atezolizumab as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The trial, conducted in collaboration with F. Hoffmann-La Roche Ltd (Roche), will measure the progression-free survival and overall survival benefits of lurbinectedin in combination with atezolizumab administered in combination compared to atezolizumab alone. The primary objective of IMforte is to determine the ability of this new combination to improve outcomes for patients with ES-SCLC, compared with standard-of-care first-line maintenance as measured by progression-free survival and overall survival.

Neuroscience

Study of the safety and efficacy of suvecaltamide (JZP385) in people with moderate to severe essential tremor

This is a phase 2b clinical study (NCT05122650) evaluating the investigational medication suvecaltamide (JZP385) for the treatment of adult patients with moderate to severe essential tremor. The purpose of this study is to learn more about the safety and tolerability of the study medication, as well as to evaluate whether the study medication will improve disability associated with tremor. The study is enrolling people (age 18-80 years) who have been diagnosed with ET according to the Movement Disorder Society Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson’s and Movement Disorder Society. Patients must also have moderate to severe disability associated with their tremor as defined by the Tremor Research Group Essential Tremor Rating Scale [TETRAS] and clinician’s assessment.