Clinical trial • Phase II • Infectious Disease
Rezafungin acetate for Chronic pulmonary aspergillosis
Phase II trial of Rezafungin acetate for Chronic pulmonary aspergillosis. open-label, none/not specified-controlled. 37 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic pulmonary aspergillosis
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 03-04-2025
- First CTIS Authorization Date
- 25-07-2025
Trial design
open-label, none/not specified-controlled Phase II trial in Hungary, Spain, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 37
- Trial Duration For Participant
- 180
Eligibility
Recruits 37 The record indicates vulnerable population selection (isVulnerablePopulationSelected: true). Participants must be adults (see inclusion: "Males or females ≥18 years of age (≥19 years in Republic of Korea), willing and able to provide written informed consent."). Consent is required in writing from the participant; no assent process for minors is provided (study enrols adults only)..
- Pregnancy Exclusion
- Pregnant or lactating females.
- Vulnerable Population
- The record indicates vulnerable population selection (isVulnerablePopulationSelected: true). Participants must be adults (see inclusion: "Males or females ≥18 years of age (≥19 years in Republic of Korea), willing and able to provide written informed consent."). Consent is required in writing from the participant; no assent process for minors is provided (study enrols adults only).
Inclusion criteria
- {"criterion_text":"- Males or females ≥18 years of age (≥19 years in Republic of Korea), willing and able to provide written informed consent."}
- {"criterion_text":"- Patients with an established diagnosis of CPA according to ESCMID/ERS/ECMM criteria (2016) which must be present for ≥3 months, unable to receive systemic azole antifungal therapy, and where antifungal treatment is indicated according to the opinion of the investigator due to radiological changes consistent with CPA progression OR high burden of symptoms."}
- {"criterion_text":"- Female subjects of child-bearing potential must agree to use one highly effective contraceptive methods of birth control, or sexual abstinence, while participating in this study and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from heterosexual intercourse, or agree to use barrier contraception, unless the partner is >2 years post-menopausal or otherwise sterile, and agree not to donate sperm while participating in the study and for 120 days from the last dose of study drug."}
- {"criterion_text":"- [A full list of inclusion criteria is included in the study protocol.]"}
Exclusion criteria
- {"criterion_text":"- Subjects with invasive aspergillosis or simple aspergilloma, known or suspected hypersensitivity to rezafungin, any echinocandin or any of their excipients, and current participation in another interventional treatment trial with an investigational agent."}
- {"criterion_text":"- Recent use of an investigational medicinal product (IMP) within 28 days or 5 half-lives of the IMP, whichever is greater, administration of any other echinocandin or IV antifungal treatment within 3 months of screening, administration of ≥15mg prednisolone daily (or equivalent corticosteroid) for at least 3 weeks within 4 weeks of screening, OR a peripheral neutrophil count <0.5x10[to the power of 9]/L."}
- {"criterion_text":"- Acute respiratory infections considered inadequately treated, subjects with active malignancy who are undergoing chemotherapy or radiation therapy."}
- {"criterion_text":"- Other conditions or laboratory abnormality that, in the opinion of the Investigator, would put the subject at unacceptable risk or interfere with the assessments included in the study."}
- {"criterion_text":"- Subjects with NCI-CTCAE Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy and/or a history of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder, therapy with a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of NCI-CTCAE Grade 1 or higher."}
- {"criterion_text":"- Pregnant or lactating females."}
- {"criterion_text":"- [A full list of exclusion criteria is included in the study protocol.]"}
Endpoints
Primary endpoints
- {"endpoint_text":"- [Clinical 1:] SGRQ - a patient reported outcome questionnaire (improvement, stable or deterioration of quality of life)","definition_or_measurement_approach":"Patient-reported St George's Respiratory Questionnaire (SGRQ) assessing improvement, stability or deterioration of quality of life."}
- {"endpoint_text":"- [Clinical 2:] Weight (weight gain / loss)","definition_or_measurement_approach":"Change in participant weight (gain or loss) measured from baseline."}
- {"endpoint_text":"- [Radiological:] CT thoracic scan to assess radiological improvement (CT changes assessed by a central imaging vendor)","definition_or_measurement_approach":"Thoracic CT scans assessed centrally by a central imaging vendor to determine radiological improvement."}
Secondary endpoints
- {"endpoint_text":"- Change in Aspergillus IgG levels, weight, SGRQ score, Respiratory Symptom Score and EQ-5D-5L score at 3 and 6 months from baseline","definition_or_measurement_approach":"Changes measured at 3 and 6 months from baseline for Aspergillus IgG, weight, SGRQ, Respiratory Symptom Score and EQ-5D-5L."}
- {"endpoint_text":"- Need for antibiotic treatment, change in antibiotic treatment or change in steroid dose","definition_or_measurement_approach":"Assessment of requirement for antibiotics, any change in antibiotic therapy, or changes in steroid dosing."}
- {"endpoint_text":"- Absence of persistently positive respiratory sample for Aspergillus spp.","definition_or_measurement_approach":"Microbiological assessment of respiratory samples for persistent positivity for Aspergillus spp."}
- {"endpoint_text":"- Change in frequency of echinocandin resistant isolates","definition_or_measurement_approach":"Microbiological surveillance measuring frequency of echinocandin-resistant isolates over time."}
- {"endpoint_text":"- Hospitalisations attributed to deterioration in any category","definition_or_measurement_approach":"Recording of hospitalisations attributable to clinical deterioration."}
- {"endpoint_text":"- Safety and tolerability of up to 6 months’ treatment; this will be assessed by nature and severity of adverse events (AEs) and serious adverse events (SAEs), physical examinations and laboratory tests","definition_or_measurement_approach":"Safety assessed via AEs and SAEs reporting, physical examinations and laboratory tests during up to 6 months of treatment."}
- {"endpoint_text":"- [Exploratory endpoint:] Rezafungin plasma concentrations","definition_or_measurement_approach":"Measurement of rezafungin plasma concentrations (pharmacokinetic sampling)."}
Recruitment
- Planned Sample Size
- 37
- Recruitment Window Months
- 15
- Consent Approach
- Written informed consent is required from participants: inclusion criteria state participants must be "willing and able to provide written informed consent." Subject information and informed consent forms (L1_SIS and ICF - adults) and related patient-facing documents (including pregnancy follow-up forms and participant brochures) are available in multiple country/language-specific versions (examples in English, German, French, Italian, Spanish, Hungarian and BE variants as listed among documents). No assent procedures (for minors) are provided since the study enrols adults only.
Methods
- Referral letters to general practitioners (GP) (documents: 'D4_Patient facing documents_* - GP letter_public', 'K2_Recruitment material - referral letter_public') intended to facilitate referrals from primary care to sites.
- Study posters (documents: 'K2_Recruitment Material - study poster_public') placed at investigational sites to inform potential participants.
- Participant brochures and site subject information (documents: 'L2_Other subject information material - participant brochure_public', 'L1_SIS and ICF - adults_public') provided to prospective participants at sites.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 31
Hungary
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 240
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Orszagos Koranyi Pulmonologiai Intezet
- Department Name
- XIV. Pulmonólogiai Osztály
- Principal Investigator Name
- Gabriella Temesi
- Principal Investigator Email
- temesi@koranyi.hu
- Contact Person Name
- Gabriella Temesi
- Contact Person Email
- temesi@koranyi.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 243
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Unidad de Trasplante Pulmonar y Fibrosis Quística
- Principal Investigator Name
- Amparo Solé Jover
- Principal Investigator Email
- sole_amp@gva.es
- Contact Person Name
- Amparo Solé Jover
- Contact Person Email
- sole_amp@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Departamento de Enfermedades Infecciosas
- Principal Investigator Name
- Oscar Manuel Len Abad
- Principal Investigator Email
- oscar.len@vhir.org
- Contact Person Name
- Oscar Manuel Len Abad
- Contact Person Email
- oscar.len@vhir.org
- Site Name
- Bellvitge University Hospital
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Núria Sabé Fernández
- Principal Investigator Email
- nfsabe@bellvitgehospital.cat
- Contact Person Name
- Núria Sabé Fernández
- Contact Person Email
- nfsabe@bellvitgehospital.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Jesús Fortún Abete
- Principal Investigator Email
- jesus.fortun@salud.madrid.org
- Contact Person Name
- Jesús Fortún Abete
- Contact Person Email
- jesus.fortun@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Servicio de Enfermedades Infecciosas del departamento de Medicina Interna
- Principal Investigator Name
- Joaquin Lopez- Contreras Gonzalez
- Principal Investigator Email
- jlcontreras@santpau.cat
- Contact Person Name
- Joaquin Lopez- Contreras Gonzalez
- Contact Person Email
- jlcontreras@santpau.cat
- Site Name
- Fundacio Hospital Sant Joan De Deu De Martorell
- Department Name
- Servicio de Neumología
- Principal Investigator Name
- Annie Navarro Rolon
- Principal Investigator Email
- ANAVARRO@HMARTORELL.CAT
- Contact Person Name
- Annie Navarro Rolon
- Contact Person Email
- ANAVARRO@HMARTORELL.CAT
Germany
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 248
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Abteilung Pneumologie/Infektiologie
- Principal Investigator Name
- Justin Hetrodt
- Principal Investigator Email
- j.hetrodt@asklepios.com
- Contact Person Name
- Justin Hetrodt
- Contact Person Email
- j.hetrodt@asklepios.com
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I für Innere Medizin
- Principal Investigator Name
- Rosanne Sprute
- Principal Investigator Email
- rosanne.sprute@uk-koeln.de
- Contact Person Name
- Rosanne Sprute
- Contact Person Email
- rosanne.sprute@uk-koeln.de
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- Studienabteilung
- Principal Investigator Name
- Fabian Leo
- Principal Investigator Email
- Fabian.Leo@jsd.de
- Contact Person Name
- Fabian Leo
- Contact Person Email
- Fabian.Leo@jsd.de
France
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 288
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Service de pneumologie, oncologie thoracique et soins intensifs respiratoires
- Principal Investigator Name
- Helène MORISSE-PRADIER
- Principal Investigator Email
- helene.morisse@chu-rouen.fr
- Contact Person Name
- Helène MORISSE-PRADIER
- Contact Person Email
- helene.morisse@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hôpital Haut- Lévêque, Centre d’Investigation Clinique Plurithématique, unité pneumologie
- Principal Investigator Name
- Elodie BLANCHARD
- Principal Investigator Email
- elodie.blanchard@chu-bordeaux.fr
- Contact Person Name
- Elodie BLANCHARD
- Contact Person Email
- elodie.blanchard@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Service de Pneumologie et réanimation respiratoire
- Principal Investigator Name
- Claire ANDREJAK
- Principal Investigator Email
- pneumologie.secretariat@chu-amiens.fr
- Contact Person Name
- Claire ANDREJAK
- Contact Person Email
- pneumologie.secretariat@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Pneumologie, Allergologie et Oncologie thoracique
- Principal Investigator Name
- Arnaud BOURDIN
- Principal Investigator Email
- a-bourdin@chu-montpellier.fr
- Contact Person Name
- Arnaud BOURDIN
- Contact Person Email
- a-bourdin@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pneumologie et Immuno-Allergologie
- Principal Investigator Name
- Jean-François Bervar
- Principal Investigator Email
- jean-francois.bervar@chu-lille.fr
- Contact Person Name
- Jean-François Bervar
- Contact Person Email
- jean-francois.bervar@chu-lille.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-07-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 237
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Monique Reijers
- Principal Investigator Email
- monique.reijers@radboudumc.nl
- Contact Person Name
- Monique Reijers
- Contact Person Email
- monique.reijers@radboudumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 20-06-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 308
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Clinic of Infectious and Tropical Diseases
- Principal Investigator Name
- Malgorzata Karolina Mikulska
- Principal Investigator Email
- m.mikulska@unige.it
- Contact Person Name
- Malgorzata Karolina Mikulska
- Contact Person Email
- m.mikulska@unige.it
- Site Name
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Department Name
- U.O.C. Malattie Infettive dell’Apparato Respiratorio
- Principal Investigator Name
- Fabrizio Palmieri
- Principal Investigator Email
- Fabrizio.palmieri@inmi.it
- Contact Person Name
- Fabrizio Palmieri
- Contact Person Email
- Fabrizio.palmieri@inmi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Infectious Diseases Unit
- Principal Investigator Name
- Michele Bartoletti
- Principal Investigator Email
- Michele.bartoletti@humanitas.eu
- Contact Person Name
- Michele Bartoletti
- Contact Person Email
- Michele.bartoletti@humanitas.eu
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Presidio Ospedaliero di Cisanello, UO Malattie Infettive
- Principal Investigator Name
- Marco Falcone
- Principal Investigator Email
- Marco.falcone@unipi.it
- Contact Person Name
- Marco Falcone
- Contact Person Email
- Marco.falcone@unipi.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-06-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 308
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- UZ Leuven
- Department Name
- Department of Respiratory Diseases
- Principal Investigator Name
- Natalie LORENT
- Principal Investigator Email
- natalie.lorent@uzleuven.be
- Contact Person Name
- Natalie LORENT
- Contact Person Email
- natalie.lorent@uzleuven.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Service de pneumologie
- Principal Investigator Name
- François CARLIER
- Principal Investigator Email
- francois.carlier@chuuclnamur.uclouvain.be
- Contact Person Name
- François CARLIER
- Contact Person Email
- francois.carlier@chuuclnamur.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Service de pneumologie
- Principal Investigator Name
- Eva VAN BRAECKEL
- Principal Investigator Email
- Eva.VanBraeckel@UGent.be
- Contact Person Name
- Eva VAN BRAECKEL
- Contact Person Email
- Eva.VanBraeckel@UGent.be
- Site Name
- Hopital Erasme
- Department Name
- Clinique des Maladies infectieuses
- Principal Investigator Name
- Maya HITES
- Principal Investigator Email
- maya.hites@hubruxelles.be
- Contact Person Name
- Maya HITES
- Contact Person Email
- maya.hites@hubruxelles.be
Austria
- Earliest CTIS Part Ii Submission Date
- 09-07-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 289
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Univ.klinik für Innere Medizin 4, Klinische Abteilung für Infektiologie und Tropenmedizin
- Principal Investigator Name
- Helmut Salzer
- Principal Investigator Email
- Helmut.Salzer@kepleruniklinikum.at
- Contact Person Name
- Helmut Salzer
- Contact Person Email
- Helmut.Salzer@kepleruniklinikum.at
Sponsor
Primary sponsor
- Full Name
- Mundipharma Research Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Almac Clinical Services Limited
- Responsibilities
- codes: 14, 3
- Name
- Scope International AG
- Responsibilities
- codes: 1, 11, 12, 15 (Medical monitoring), 2, 5, 6, 8
- Name
- Fortrea Belgium
- Responsibilities
- codes: 8
- Name
- LKF Laboratorium fuer Klinische Forschung GmbH
- Responsibilities
- codes: 15 (Laboratory samples: kits, transport, storage)
Third parties
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes: 14, 3","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Scope International AG","duties_or_roles":"codes: 1, 11, 12, 15 (Medical monitoring), 2, 5, 6, 8","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Fortrea Belgium","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"LKF Laboratorium fuer Klinische Forschung GmbH","duties_or_roles":"codes: 15 (Laboratory samples: kits, transport, storage)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Ilife Consulting","duties_or_roles":"codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Jones Microbiology Institute Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Radboud universitair medisch centrum Stichting","duties_or_roles":"codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Italy","full_name":"Latis S.r.l.","duties_or_roles":"codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Keosys","duties_or_roles":"codes: 15 (Central review of CT scans), 7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- REZZAYO 200 mg powder for concentrate for solution for infusion
- Active Substance
- Rezafungin acetate
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing-authorised (EU/1/23/1775/001)
- Maximum Dose
- 400 mg (max daily)
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