Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

NCT03667690 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CD101.IV.3.05
• Study Type: interventional
• Target: 199
• Locations: 18 countries
• Sites: 132

Brief Summary

The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).

Conditions

Candidemia; Mycoses; Fungal Infection; Invasive Candidiases

Keywords

Mycoses; Candidiasis; Candidiasis, Invasive; Candidemia; Fungemia; Sepsis; Invasive Fungal Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Fluconazole; Caspofungin; Echinocandins; Antifungal Agents; Anti-infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors

Outcome Measures

Primary Outcomes (2)

• All-Cause Mortality (US FDA Only)

  The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.

  Day 30 (-2 days)

• Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only)

  The number and percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure \[for qualifying invasive candidiasis subjects at baseline\], and mycological eradication, as confirmed by the Data Review Committee \[DRC\]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.

  Day 14 (±1 day)

Secondary Outcomes (11)

• Global Response as Assessed by Data Review Committee (US FDA Only)

  Day 14 (±1 day)

• All-Cause Mortality (EU EMA Only)

  Day 30 (-2 days)

• Comparison of Global Response (as Assessed by the DRC) by Visit

  Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59)

• Comparison of Mycological Eradication by Visit

  Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)

• Comparison of Investigators' Assessment of Clinical Response by Visit

  Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)

Study Arms (2)

Group 1: Rezafungin for Injection

EXPERIMENTAL

Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day.

Drug: Rezafungin for Injection; Drug: oral placebo

Group 2: Caspofungin

ACTIVE COMPARATOR

Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.

Drug: Caspofungin; Drug: Fluconazole; Drug: intravenous placebo

Interventions

Rezafungin for Injection DRUG

Intravenous antifungal therapy

Group 1: Rezafungin for Injection

Caspofungin DRUG

Intravenous antifungal therapy

Also known as: Cancidas

Group 2: Caspofungin

Fluconazole DRUG

Oral antifungal therapy

Also known as: generic fluconazole

Group 2: Caspofungin

intravenous placebo DRUG

Normal saline

Also known as: placebo infusion

Group 2: Caspofungin

oral placebo DRUG

Microcrystalline cellulose

Also known as: encapsulated cellulose

Group 1: Rezafungin for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on his/her behalf.
• Males or females ≥18 years of age.
• Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
• ≥1 blood culture positive for yeast or Candida OR
• Positive test for Candida from a Sponsor-approved rapid in vitro diagnostic (IVD) OR
• Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
• Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of randomization.
• Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
• Female subjects of childbearing potential (all female subjects between 18 years \<2 years post-menopausal unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).

You may not qualify if:

• Any of the following forms of invasive candidiasis at baseline:
• Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
• Osteomyelitis
• Endocarditis or myocarditis
• Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
• Chronic disseminated candidiasis
• Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
• Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for \>48 hours (e.g., \>2 doses of a once daily antifungal agent or \>4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization
• a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
• Alanine aminotransferase or aspartate aminotransferase levels \>10-fold the upper limit of normal
• Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score \>9)
• Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
• Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
• Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
• History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)

Sponsors & Collaborators

• Cidara Therapeutics Inc.: lead

Study Sites (132)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Hospital-Rochester

Rochester, Minnesota, 55902, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

Mecury Street Medical

Butte, Montana, 59701, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

ID Clinical Research, Ltd.

Toledo, Ohio, 43608, United States

Location

University of Pittsburgh Falk Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Reading Hospital and Medical Center

West Reading, Pennsylvania, 19611, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Alexander Fleming Specialized Medical Institute

Buenos Aires, Argentina

Location

Cordoba Private Hospital

Córdoba, 5016, Argentina

Location

Allende Sanatorium

Córdoba, Argentina

Location

Mayo Private Sanatorium

Córdoba, Argentina

Location

Italian Hospital of Mendoza

Mendoza, Argentina

Location

Westmead Public Hospital

Northmead, New South Wales, 2152, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital (RMH)

Parkville, Victoria, 3052, Australia

Location

Brugmann University Hospital Center

Brussels, 1020, Belgium

Location

Erasme Hospital

Brussels, 1070, Belgium

Location

University Hospital Brussels

Brussels, 1090, Belgium

Location

Saint Luc University Hospital

Brussels, 1200, Belgium

Location

University Hospitals Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Multiprofile Hospital for Active Treatment Puls

Blagoevgrad, 2700, Bulgaria

Location

University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery

Sofia, 1606, Bulgaria

Location

University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD

Sofia, 1606, Bulgaria

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

The Second People's Hospital of Hefei

Hefei, Anhui, 230011, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Chongqing People's Hospital

Chongqing, Chongqing Municipality, 400013, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, 511500, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Zibo Central Hospital

Zibo, Shandong, 255036, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610065, China

Location

Huashan Hospital Affiliated Fudan University

Shanghai, 200040, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, 300020, China

Location

General Hospital of Tianjin Medical University

Tianjin, 300052, China

Location

CEQUIN Foundation Cardiomet

Armenia, 630002, Colombia

Location

De La Costa Clinic Ltd.

Barranquilla, 080020, Colombia

Location

University IPS - Leon XIII Clinic

Medellín, 050012, Colombia

Location

Amiens Picardie University Hospital - South

Amiens, 80480, France

Location

Centre Hospitalier Victor Dupouy - Argenteuil

Argenteuil, 95107, France

Location

Roger Salengro Hospital

Lille, 59037, France

Location

Marseille University Hospital Center - North Hospital

Marseille, 13015, France

Location

Hotel Dieu Hospital Nantes University Hospital Center

Nantes, 44093, France

Location

Saint-Louis Hospital

Paris, 75475, France

Location

Paris University Hospitals Center - Cochin Hospital

Paris, 95107, France

Location

University Hospital Center of Poitiers

Poitiers, 86021, France

Location

Civil Hospital of Strasbourg

Strasbourg, 67091, France

Location

Tours University Hospital Center, Bretonneau Hospital

Tours, 37000, France

Location

University Hospital Köln

Cologne, 50937, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Johannes Gutenberg University Medical Center

Mainz, 55131, Germany

Location

General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

Athens, 10676, Greece

Location

General Hospital of Athens "Evangelismos"

Athens, 10676, Greece

Location

General Hospital of Athens "Laikon", Infectious Diseases Unit

Athens, 11527, Greece

Location

General Hospital of Athens "Laikon"

Athens, 11527, Greece

Location

General Hospital of Thessaloniki Ippokratio

Thessaloniki, 54642, Greece

Location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

Location

Rambam Health Care Campus

Haifa, 35254, Israel

Location

Edith Wolfson Medical Center

Holon, 5822012, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

The Baruch Padeh Medical Center

Nazareth, 16100, Israel

Location

Ziv Medical Center

Safed, 1311001, Israel

Location

The Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 5262000, Israel

Location

Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants

Bologna, 40138, Italy

Location

ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department

Milan, 20161, Italy

Location

University Polyclinic Hospital of Modena

Modena, 41124, Italy

Location

University Hospital of Modena

Modena, 71-41124, Italy

Location

University of Milano-Bicocca - San Gerardo Hospital

Monza, 20900, Italy

Location

University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU

Palermo, 90127, Italy

Location

University Polyclinic Foundation Agostino Gemelli - IRCCS

Rome, 00168, Italy

Location

Integrated University Health Authority of Trieste

Trieste, 34125, Italy

Location

Integrated University Hospital "Santa Maria della Misericordia" of Udine

Udine, 22100, Italy

Location

National University Hospital

Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, 119074, Singapore

Location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Chung-Ang University Hospital

Seoul, 06793, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

University Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

University Hospital Cruces

Barakaldo, 48903, Spain

Location

Hospital del Mar, Department of Infectious Diseases

Barcelona, 08003, Spain

Location

University Hospital Vall d'Hebron (HUVH)

Barcelona, 08035, Spain

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Parc Tauli Health Corporation

Barcelona, 08208, Spain

Location

General University Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

University Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

University Hospital Clinical San Carlos

Madrid, 28040, Spain

Location

La Paz University Hospital

Madrid, 28046, Spain

Location

University Hospital Puerta de Hierro Majadahonda

Majadahonda, 28220, Spain

Location

University Hospital Virgen Macarena

Seville, 41009, Spain

Location

University and Polytechnic Hospital La Fe

Valencia, 46026, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Hacettepe University School of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University School of Medicine

Ankara, 06230, Turkey (Türkiye)

Location

Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

• Huang H, Feng S, Yu Y, Zhang Y, Yuan Y, Cox L, Zhang Y. Efficacy and Safety of Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis in a China Cohort of a Double-Blind, Randomised, Phase 3 Trial (ReSTORE China). Mycoses. 2025 Nov;68(11):e70122. doi: 10.1111/myc.70122.

  PMID: 41194465 DERIVED

• Honore PM, Bassetti M, Cornely OA, Dupont H, Fortun J, Kollef MH, Pappas P, Pullman J, Vazquez J, Bielicka I, Dickerson S, Manamley N, Sandison T, Thompson GR. Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials. Crit Care. 2024 Nov 11;28(1):361. doi: 10.1186/s13054-024-05152-2.

  PMID: 39529079 DERIVED

• Honore PM, Girardis M, Kollef M, Cornely OA, Thompson GR 3rd, Bassetti M, Soriano A, Huang H, Vazquez J, Kullberg BJ, Pappas PG, Manamley N, Sandison T, Pullman J, Nseir S. Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trials. Crit Care. 2024 Oct 28;28(1):348. doi: 10.1186/s13054-024-05117-5.

  PMID: 39468640 DERIVED

• Clarke F, Grenfell A, Chao S, Richards H, Korman T, Rogers B. Use of echinocandin outpatient parenteral antimicrobial therapy for the treatment of infection caused by Candida spp.: utilization, outcomes and impact of a change to weekly dosing. J Antimicrob Chemother. 2024 Nov 4;79(11):2896-2900. doi: 10.1093/jac/dkae302.

  PMID: 39259571 DERIVED

• Soriano A, Honore PM, Cornely OA, Chayakulkeeree M, Bassetti M, Haihui H, Dupont H, Kim YK, Kollef M, Kullberg BJ, Manamley N, Pappas P, Pullman J, Sandison T, Dignani C, Vazquez JA, Thompson GR 3rd. Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study. Clin Infect Dis. 2024 Sep 26;79(3):672-681. doi: 10.1093/cid/ciae363.

  PMID: 38985561 DERIVED

• Smith HL, Bensman TJ, Mishra S, Li X, Dixon CA, Sheikh J, McMaster OG, Joshi A, Rubin DB, Goodwin A, Miller TJ, Danielsen ZY, Syed I, Shukla SJ, Iarikov D, Kim PW, Farley JJ. Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults. J Infect Dis. 2024 Aug 16;230(2):505-513. doi: 10.1093/infdis/jiae146.

  PMID: 38502709 DERIVED

• Thompson GR 3rd, Soriano A, Honore PM, Bassetti M, Cornely OA, Kollef M, Kullberg BJ, Pullman J, Hites M, Fortun J, Horcajada JP, Kotanidou A, Das AF, Sandison T, Aram JA, Vazquez JA, Pappas PG. Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials. Lancet Infect Dis. 2024 Mar;24(3):319-328. doi: 10.1016/S1473-3099(23)00551-0. Epub 2023 Nov 23.

  PMID: 38008099 DERIVED

• Thompson GR 3rd, Soriano A, Cornely OA, Kullberg BJ, Kollef M, Vazquez J, Honore PM, Bassetti M, Pullman J, Chayakulkeeree M, Poromanski I, Dignani C, Das AF, Sandison T, Pappas PG; ReSTORE trial investigators. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial. Lancet. 2023 Jan 7;401(10370):49-59. doi: 10.1016/S0140-6736(22)02324-8. Epub 2022 Nov 25.

  PMID: 36442484 DERIVED

• Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217.

  PMID: 33438477 DERIVED

MeSH Terms

Conditions

Candidemia; Mycoses; Candidiasis, Invasive; Candidiasis; Fungemia; Sepsis; Invasive Fungal Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes

Interventions

Rezafungin; Injections; Caspofungin; Fluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Inflammation; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Taylor Sandison, M.D., MPH
• Organization: Cidara Therapeutics, Inc.

clinicaltrialinfo@cidara.com

858-888-7868

Study Officials

• Taylor Sandison, MD, MPH

  Cidara Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 12, 2018
• Study Start: October 7, 2018
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: January 6, 2023
• Results First Posted: January 6, 2023

Record last verified: 2022-12

Locations

TW (5); ES (13); SG (2); FR (10); TH (8); TU (5); AR (5); IT (9); CO (3); US (19); CN (17); DE (3); GR (5); BE (5); KR (6); BU (3); IL (9); AU (5)