CandidemiaPhase 3NCT05421858
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
A Phase 3 study testing Fosmanogepix, Caspofungin and Fluconazole in people with Candidemia and Candidiasis, Invasive, run by Basilea Pharmaceutica at 146 sites in 20 countries.
Trial summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia, Candidiasis, Invasive
- What is being tested?
- Fosmanogepix, Caspofungin and Fluconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 146 sitesin 20 countries
- Study dates
- 11 Dec 2024to 30 Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
- Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.
- Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
Who cannot join
- Existing infection
- Infection known to be due to Candida krusei, in blood or any other normally sterile site.
- Inappropriate fungal infection source control.
- Diagnosis of certain deep-seated Candida infections.
- Life expectancy of < 72 hours in the opinion of the investigator.
- Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
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- Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary).
- Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
- Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
- Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
- Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., > 2 doses of a once daily antifungal agent or > 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
- Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
- Prior participation in this or any previous study of fosmanogepix.
- Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
- Female patient is pregnant or lactating.
- Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.
Trial locations and contacts
146 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
146 sites in 20 countries
United States23 sites, 22 recruiting
- Recruiting
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109-5000
- Recruiting
Emory University Hospital - Clifton Road
Atlanta, Georgia, 30322
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912-5563
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Recruiting
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, 35294-0006
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
DMC Harper University Hospital
Detroit, Michigan, 48201
- Recruiting
Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
Detroit, Michigan, 48202
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
Houston Methodist Hospital - Texas Medical Center
Houston, Texas, 77030
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
- Recruiting
U.T. MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Indiana University Methodist Hospital
Indianapolis, Indiana, 46202
- Withdrawn
University of Kentucky College of Medicine
Lexington, Kentucky, 40506
- Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 10065
- Recruiting
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104-6243
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2582
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
- Recruiting
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, 63110
China20 sites, 20 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233099
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510080
- Recruiting
Guangzhou First People's Hospital
Guangzhou, 510180
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510230
- Recruiting
Zhejiang Provincal Hospital of Chinese Medicine
Hangzhou, 310006
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, 310014
- Recruiting
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, 310016
- Recruiting
Lishui People's Hospital
Lishui, 323000
- Recruiting
Liuzhou People's Hospital
Liuzhou, 530021
- Recruiting
The 1st Affiliated Hospital of Nanchang University
Nanchang, 330006
- Recruiting
Qingyuan People's Hospital
Qingyuan, 511518
- Recruiting
Huashan Hospital
Shanghai, 200040
- Recruiting
Shenzhen Third People's Hospital
Shenzhen, 518112
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, 301617
- Recruiting
Central Hospital of Wuhan
Wuhan, 430014
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, 430071
- Recruiting
Wuxi People's Hospital
Wuxi, 214023
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Zhengzhou, 471003
Italy10 sites, 10 recruiting
- Recruiting
Hospital "S. Croce e Carle"
Cuneo, 12100
- Recruiting
IRCCS Policlinic Hospital San Martino
Genoa, 16132
- Recruiting
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
- Recruiting
Hospital San Raffaele, IRCCS
Milan, 20132
- Recruiting
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, 20162
- Recruiting
University Polyclinic Hospital of Modena
Modena, 41124
- Recruiting
Polyclinic San Matteo, IRCCS
Pavia, 27100
- Recruiting
University Hospital of Pisa
Pisa, 56124
- Recruiting
AOU Senese
Siena, 53100
- Recruiting
Giuliano Isontina University Health Authority
Trieste, 34125
Taiwan9 sites, 9 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
- Recruiting
China Medical University Hospital
Taichung, 404327
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
- Recruiting
National Taiwan University Hospital
Taipei, 100226
- Recruiting
Taipei Medical University Hospital
Taipei, 11000
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
Belgium7 sites, 6 recruiting
- Recruiting
General Hospital Saint-Jan
Bruges, 8000
- Recruiting
University Hospital Brussels
Brussels, 1090
- Recruiting
Saint Luc University Hospital, Department of Internal Medicine
Brussels, 1200
- Recruiting
Erasme Hospital, Department of Infectious and Tropical Diseases
Brussels, B-1070
- Recruiting
Jessa Hospital
Hasselt, 3500
- Recruiting
University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases
Leuven, 3000
- Suspended
UCL Mont-Godinne University Hospitals
Yvoir, 5530
Spain7 sites, 7 recruiting
- Recruiting
University Hospital Cruces
Barakaldo, 48903
- Recruiting
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia, 08003
- Recruiting
University Hospital Vall d'Hebron, Intensive Care Unit (ICU)
Barcelona, Catalonia, 08035
- Recruiting
Hospital Clinic of Barcelona, Department of Infectious Diseases
Barcelona, Catalonia, 08036
- Recruiting
University Hospital Ramon y Cajal, Department of Infectious Diseases
Madrid, Madrid, 28034
- Recruiting
University Hospital Virgen Macarena
Seville, Andalusia, 41009
- Recruiting
University Hospital Nuestra Senora de Valme
Seville, Andalusia, 41014
Argentina6 sites, 5 recruiting
- Recruiting
Central Hospital de San Isidro Melchor Posse
Buenos Aires, B1641
- Recruiting
Buenos Aires Italian Hospital, Department of Infectious Diseases
Buenos Aires, C1199ABB
- Recruiting
Cordoba Private University Hospital, Department of Infectious Diseases
Córdoba, X5016KEH
- Recruiting
Italian Hospital of La Plata, Department of Infectious Diseases
La Plata, B1900
- Terminated
Central Hospital Mendoza
Mendoza, M5500IDN
- Recruiting
British Sanatorium SA
Rosario, S2000CVB
Australia6 sites, 6 recruiting
- Recruiting
Monash Medical Center Clayton
Clayton, 3168
- Recruiting
Peter MacCallum Cancer Center, State
Melbourne, Victoria, 3000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Colombia6 sites, 6 recruiting
- Recruiting
Cardiomet CEQUIN Foundation, Department of Nephrology
Armenia, 630004
- Recruiting
Hospital Alma Mater de Antioquia
Medellín, 050012
- Recruiting
Luz Castro de Gutierrez Medellin General Hospital, Research Center
Medellín, 050015
- Recruiting
Pablo Tobon Uribe Hospital
Medellín, 050034
- Recruiting
High Technology Medical Institute S.A.S, IMAT S.A.S.
Montería, 230002
- Recruiting
Somer Clinic
Rionegro, 54040
France6 sites, 5 recruiting
- Recruiting
Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)
Amiens, 80054
- Recruiting
Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit
Argenteuil, 95107
- Suspended
Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections
Marseille, 13015
- Recruiting
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, 44000
- Recruiting
Rennes University Hospital Center - Hospital Pontchaillou
Rennes, 35000
- Recruiting
Tours Regional University Hospital Center
Tours, 37000
Germany6 sites, 6 recruiting
- Recruiting
University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases
Cologne, North Rhine-Westphalia, 50937
- Recruiting
Frankfurt University Clinic
Frankfurt am Main, Hesse, 60590
- Recruiting
University Hospital Giessen and Marburg GmbH
Giessen, Hesse, 35392
- Recruiting
University Hospital Heidelberg, Clinic for Anesthesiology
Heidelberg, 69120
- Recruiting
University Hospital Regensburg
Regensburg, Bavaria, 93053
- Recruiting
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)
Ulm, Baden-Wurttemberg, 89081
Greece6 sites, 5 recruiting
- Recruiting
"LAIKO" General Hospital
Athens, 115 27
- Recruiting
"Sotiria" Chest Diseases Hospital of Athens
Athens, 11527
- Recruiting
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
Athens, PC 10676
- Recruiting
University General Hospital of Heraklion
Heraklion, 715 00
- Suspended
Tzaneio General Hospital
Piraeus, 185 36
- Recruiting
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, 54642
Brazil5 sites, 5 recruiting
- Recruiting
HC-UFPR
Curitiba, Paraná, 80060-900
- Recruiting
Hospital Our Lady of Grace
Curitiba, Paraná, 80810-040
- Recruiting
Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine
Porto Alegre, Rio Grande do Sul, 90035-903
- Recruiting
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Santa Marcelina Hospital
São Paulo, São Paulo, 08270-070
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, 3109601
- Recruiting
Edith Wolfson Medical Center, Department of Infectious Diseases
Holon, 58100
- Recruiting
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, 52621
- Recruiting
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, 6423906
- Recruiting
Shamir Medical Center, Department of Infectious Diseases
Ẕerifin, 7033001
South Africa5 sites, 2 recruiting
- Suspended
Helen Joseph Hospital
Johannesburg, 2092
- Recruiting
Milpark Hospital
Johannesburg, 2193
- Withdrawn
Ryexo Clinical Research
Pretoria, 0084
- Suspended
University of Pretoria / Steve Biko Academic Hospital
Pretoria, 0084
- Recruiting
Practice of R Moodley and MI Sarvan - Umhlanga
Umhlanga, 4320
Thailand5 sites, 5 recruiting
- Recruiting
Vajira Hospital
Bangkok, 10300
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
- Recruiting
Songklanagarind Hospital
Hat Yai, 90110
- Recruiting
Srinagarind Hospital
Khon Kaen, 40002
Austria4 sites, 4 recruiting
- Recruiting
University Hospital Graz, Department of Internal Medicine
Graz, 1100
- Recruiting
Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases
Linz, 4021
- Recruiting
Medical University Vienna
Vienna, 1090
- Recruiting
Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine
Vienna, 1100
South Korea4 sites, 1 recruiting
- Suspended
Kyungpook National University Hospital
Daegu, 41944
- Suspended
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Suspended
Samsung Medical Center
Seoul, 06351
- Recruiting
Ajou University Hospital
Suwon, 16499
Bulgaria3 sites, 3 recruiting
- Recruiting
Eurohospital University Hospital
Plovdiv, 4004
- Recruiting
University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic
Sofia, 1606
- Recruiting
University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery
Sofia, 1606
Singapore3 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, 119074
- Recruiting
Singapore General Hospital
Singapore, 169608
- Suspended
Tan Tock Seng Hospital
Singapore, 308433
About this study
Official title: An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.
The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis.
Read more
Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.
Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital.
The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%.
The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.
- Conditions
- Candidemia, Candidiasis, Invasive
- Being tested
- Fosmanogepix, Caspofungin, Fluconazole, Placebo
- Keywords
- Fungal infection, Candida, Anti-fungal, Yeast
- Medical subject headings
- Candidemia, Candidiasis, Invasive, Mycoses, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosmanogepixDrug
IV infusion
FosmanogepixDrug
Oral tablet
CaspofunginDrug
IV infusion
FluconazoleDrug
Fluconazole oral capsule
PlaceboDrug
Matching placebo for caspofungin (IV infusion)
PlaceboDrug
Matching placebo for fluconazole (oral capsule)
PlaceboDrug
Matching placebo for fosmanogepix (IV infusion)
PlaceboDrug
Matching placebo for fosmanogepix (oral tablet)
| Study group | Role | What they receive |
|---|---|---|
| Fosmanogepix IV/oral | Experimental | Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth.
Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole). Receives: Drug: Fosmanogepix; Drug: Placebo |
| Caspofungin IV/ Fluconazole oral | Active comparator | Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth.
Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied). Receives: Drug: Caspofungin; Drug: Fluconazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive at Day 30
Measured: Day 30
Proportion of patients with an overall response of treatment success at end of study treatment (EOST)
Measured: EOST (up to Day 42)
Secondary outcomes (12)
Proportion of patients with an overall response of treatment success at Day 7
Measured: Day 7
Proportion of patients with an overall response of treatment success at Day 14
Measured: Day 14
Proportion of patients with an overall response of treatment success at end of IV treatment (EOIV)
Measured: up to Day 42
Proportion of patients with an overall response of treatment success (sustained) at follow-up 6 weeks after EOST
Measured: approximately up to 12,5 weeks
Proportion of patients with clinical response of success at Day 7, 14, EOIV, EOST, Follow-up 6- weeks after EOST
Measured: Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST]
Proportion of patients with mycological response of eradication or presumed eradication at Day 7, 14, EOIV, EOST, Follow-up 6-weeks after EOST
Measured: Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST
Time to first negative blood culture in patients on fosmanogepix compared to caspofungin/fluconazole
Measured: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Incidence of treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest (AESI)and AEs leading to discontinuation
Measured: Screening up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Number of patients with clinically significant laboratory abnormalities
Measured: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Number of patients with abnormal neurological examination findings
Measured: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Assessment of 12-lead electrocardiogram (ECGs)
Measured: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety)
Measured: Day 3: 0, 3, 6, 9 and 24 hours post-dose; Day 7, 14, 21, 28, 35; EOST: 72 and 192 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start11 Dec 2024
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Alexandra Hill, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421858
- Sponsor's protocol ID
- FMGX-CS-301
- Other IDs
- 75A50124C00033, 2022-500455-23-00
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available