A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ exclusion of active tuberculosis or non-tuberculous mycobacterial pulmonary infection or disorders that will prevent evaluation of outcome over 6 months. Patients on anti-mycobacterial therapy can be enrolled if their mycobacterial infection is stabilised

• 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

Locations
Other Locations
Austria
Kepler University Hospital
NOT_YET_RECRUITING
Linz
Belgium
Brussels University Hospital
NOT_YET_RECRUITING
Brussels
UZ Gent
NOT_YET_RECRUITING
Ghent
University Hospital Leuven
NOT_YET_RECRUITING
Leuven
CHU UCL Namur
NOT_YET_RECRUITING
Yvoir
France
CHU Amiens Picardie
NOT_YET_RECRUITING
Amiens
Institut Coeur Poumon CHU
NOT_YET_RECRUITING
Lille
CHU Arnaud de Villeneuve
NOT_YET_RECRUITING
Montpellier
CHU Bordeaux
NOT_YET_RECRUITING
Pessac
CHU de Rouen
NOT_YET_RECRUITING
Rouen
Germany
Evangelische Lungenklinik Berlin
NOT_YET_RECRUITING
Berlin
University of Cologne
NOT_YET_RECRUITING
Cologne
Asklepios Lungenfachklinik Gauting
NOT_YET_RECRUITING
Gauting
Hungary
Országos Korányi Pulmonológiai Intézet
NOT_YET_RECRUITING
Budapest
Italy
University of Genova, San Martino Hospital
NOT_YET_RECRUITING
Genova
University of Pisa
NOT_YET_RECRUITING
Pisa
INMI Lazzaro Spallanzaniconsu
NOT_YET_RECRUITING
Roma
Humanitas Research Hospital
NOT_YET_RECRUITING
Rozzano
Netherlands
Radboud Universitair Medisch Centrum Stichting
NOT_YET_RECRUITING
Nijmegen
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Seoul National University Bundang Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitari de Bellvitge
NOT_YET_RECRUITING
Barcelona
Vall d'Hebron Barcelona Hospital Campus
NOT_YET_RECRUITING
Barcelona
Ramón y Cajal Hospital
NOT_YET_RECRUITING
Madrid
Hospital Sant Joan de Deu de Martorell
NOT_YET_RECRUITING
Martorell
Hospital La Fe
NOT_YET_RECRUITING
Valencia
United Kingdom
Royal Papworth Hospital
NOT_YET_RECRUITING
Cambridge
University Hospitals of Derby and Burton
NOT_YET_RECRUITING
Derby
Western General Hospital
RECRUITING
Edinburgh
Leeds Teaching Hospital
RECRUITING
Leeds
Imperial College Hospital
RECRUITING
London
Royal Brompton Hospital, Guy's and St. Thomas' Hospital
NOT_YET_RECRUITING
London
University College London (UCL) Hospitals
RECRUITING
London
Manchester University Hospital
RECRUITING
Manchester
Contact Information
Primary
Elizabeth Chong
elizabeth.chong@mundipharma-rd.eu
+44 (0) 1223 424211
Backup
Terry Nichols
terry.nichols@mundipharma-rd.eu
+44 (0) 1223 424211
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Treatment
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).
Related Therapeutic Areas
Sponsors
Leads: Mundipharma Research Limited

This content was sourced from clinicaltrials.gov