Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options

NCT06794554 | Recruiting Phase 2

• 1 other identifier: MR907-2502
• Study Type: interventional
• Target: 60
• Locations: 10 countries
• Sites: 37

Brief Summary

The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options. The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging. Participants will:

• Be given the drug rezafungin every week for 6 months.
• Visit the clinic once a month for checkups and tests.
• Complete questionnaires on thier health and wellbeing.

Conditions

Chronic Pulmonary Aspergillosis

Keywords

Chronic pulmonary aspergillosis; Rezafungin; Rezzayo

Outcome Measures

Primary Outcomes (1)

• Change from baseline in clinical and radiological response at 6 months

  Participants achieving a clinical improvement and radioligical improvement by CT scans

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Rezafungin for Injection, IV, with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months).

Drug: Rezafungin Acetate

Interventions

Rezafungin Acetate DRUG

IV with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months).

Treatment

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
• Males or females ≥18 years of age
• Established diagnosis of CPA according to ESCMID/ERS criteria (2016) which includes all the following, which should be present for ≥3 months:
• one or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, night sweats, fever and dyspnoea)
• slowly progressive or persistent radiological findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax
• immunological, microbiological or molecular evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index \>0.5 or BALF galactomannan index \>1), positive Aspergillus IgG, or positive PCR
• Unable to receive systemic azole antifungal therapy due to any of the following: documented or anticipated resistance, intolerance, contraindication (e.g. due to drug-drug interactions or organ dysfunction), inability to take oral medication, or lack of availability. NOTE: the administration of rezafungin is monotherapy only, and subjects currently on azoles who are able to remain on therapy are not eligible
• Antifungal treatment is indicated according to the opinion of the investigator due to radiological changes consistent with CPA progression OR high burden of symptoms
• Female subjects of child-bearing potential \<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 (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subject's usual lifestyle) 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 (condom with spermicide), and agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug, unless the partner is \>2 years post-menopausal or otherwise sterile.
• Definitions: Woman of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
• A postmenopausal state: no menses for 12 months without an alternative medical cause.
• Abstinence: refraining from heterosexual intercourse (only if it corresponds to the subject's usual lifestyle)
• Willingness to comply with all aspects and assessments required in this study

You may not qualify if:

• Subjects with invasive aspergillosis, aspergillus nodules, or simple aspergilloma
• Known or suspected hypersensitivity to rezafungin for Injection or any of its excipients
• Current participation in another interventional treatment trial with an investigational agent. Participation in another interventional treatment trial is permitted during the follow-up period of the study
• Recent use of an investigational medicinal product within 28 days or 5 half-lives of the investigational medicinal product, whichever is greater, to prevent overlapping toxicities when this study's investigational product is dosed, or presence of an investigational device at the time of screening. In some cases, use of investigational products may be acceptable in consultation with the Sponsor's Medical Monitor
• Administration of any other echinocandin or intravenous antifungal treatment within 3 months of screening
• Administration of ≥15mg prednisolone daily (or other equivalent immunosuppressant) for at least 3 weeks within 4 weeks of screening
• Acute respiratory infections considered inadequately treated in the opinion of the Principal Investigator. Any subjects diagnosed with an acute respiratory infection during the screening period should be re-screened following the required course of appropriate treatment and enrolled when considered adequately treated.
• Subjects with active malignancy who are receiving chemotherapy or radiation therapy
• Severely immunocompromising conditions according to the opinion of the investigator such as bone marrow transplantation, neutropenia, or have received cancer chemotherapy within last 6 months
• Subjects on the palliative care pathway
• Any other condition or laboratory abnormality that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study
• A. Meets National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher B. 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)
• Planned or ongoing therapy at Screening 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 CTCAE version 5.0 Grade 1 or higher.
• Pregnant or lactating females

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (37)

Kepler University Hospital

Linz, Austria

NOT YET RECRUITING

Brussels University Hospital

Brussels, Belgium

NOT YET RECRUITING

UZ Gent

Ghent, Belgium

NOT YET RECRUITING

University Hospital Leuven

Leuven, Belgium

NOT YET RECRUITING

CHU UCL Namur

Yvoir, Belgium

NOT YET RECRUITING

CHU Amiens Picardie

Amiens, France

NOT YET RECRUITING

Institut Coeur Poumon CHU

Lille, France

NOT YET RECRUITING

CHU Arnaud de Villeneuve

Montpellier, France

NOT YET RECRUITING

CHU Bordeaux

Pessac, France

NOT YET RECRUITING

CHU de Rouen

Rouen, France

NOT YET RECRUITING

Evangelische Lungenklinik Berlin

Berlin, Germany

NOT YET RECRUITING

University of Cologne

Cologne, Germany

NOT YET RECRUITING

Asklepios Lungenfachklinik Gauting

Gauting, Germany

NOT YET RECRUITING

Országos Korányi Pulmonológiai Intézet

Budapest, Hungary

NOT YET RECRUITING

University of Genova, San Martino Hospital

Genova, Italy

NOT YET RECRUITING

University of Pisa

Pisa, Italy

NOT YET RECRUITING

INMI Lazzaro Spallanzaniconsu

Roma, Italy

NOT YET RECRUITING

Humanitas Research Hospital

Rozzano, Italy

NOT YET RECRUITING

Radboud Universitair Medisch Centrum Stichting

Nijmegen, Netherlands

NOT YET RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitari de Bellvitge

Barcelona, Spain

NOT YET RECRUITING

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Spain

NOT YET RECRUITING

Ramón y Cajal Hospital

Madrid, Spain

NOT YET RECRUITING

Hospital Sant Joan de Deu de Martorell

Martorell, Spain

NOT YET RECRUITING

Hospital La Fe

Valencia, Spain

NOT YET RECRUITING

Royal Papworth Hospital

Cambridge, United Kingdom

NOT YET RECRUITING

University Hospitals of Derby and Burton

Derby, United Kingdom

NOT YET RECRUITING

Western General Hospital

Edinburgh, United Kingdom

RECRUITING

Leeds Teaching Hospital

Leeds, United Kingdom

RECRUITING

Imperial College Hospital

London, United Kingdom

RECRUITING

Royal Brompton Hospital, Guy's and St. Thomas' Hospital

London, United Kingdom

NOT YET RECRUITING

University College London (UCL) Hospitals

London, United Kingdom

RECRUITING

Manchester University Hospital

Manchester, United Kingdom

RECRUITING

MeSH Terms

Interventions

Rezafungin

Central Study Contacts

Elizabeth Chong

CONTACT

+44 (0) 1223 424211; elizabeth.chong@mundipharma-rd.eu

Terry Nichols

CONTACT

+44 (0) 1223 424211; terry.nichols@mundipharma-rd.eu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: January 27, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

KR (4); AU (1); HU (1); FR (5); DE (3); ES (6); IT (4); GB (8); NL (1); BE (4)