NCT06925321 A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
| NCT ID | NCT06925321 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Basilea Pharmaceutica |
| Condition | Invasive Mold Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 234 participants in total. It began in 2025-08-26 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Eligibility Criteria
Main Inclusion Criteria: 1. Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds. 2. Patient's condition allows for appropriate infection source control measures. Main Exclusion Critera: 1. Refractory hematologic malignancy. 2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis. 3. Coronavirus disease 2019 (COVID-19) associated mucormycosis. 4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B. 5. Patients with a Karnofsky Performance Status \< 20 at Screening. 6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration. 7. Patients with known human immunodeficiency virus infection. 8. Ongoing neurological disorders. 9. Patients receiving hospice/comfort care only. 10. Other medical or psychiatric condition. 11. Current use of any prohibited concomitant medication(s). 12. Current/ previous administration of an investigational drug within 30 days. 13. Prior enrollment in this or any previous study of fosmanogepix. 14. Moderate or severe hepatic impairment. 15. Patient who is pregnant or lactating. 16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
Contact & Investigator
Alison Kuchta, MD
STUDY DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Frequently Asked Questions
Who can join the NCT06925321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Invasive Mold Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06925321 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 234 participants.
Is NCT06925321 currently recruiting?
Yes, NCT06925321 is actively recruiting participants. Contact the research team at kuchtaa@basileapharma.com for enrollment information.
Where is the NCT06925321 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, Los Angeles, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT06925321 clinical trial?
NCT06925321 is sponsored by Basilea Pharmaceutica. The principal investigator is Alison Kuchta, MD at Basilea Pharmaceutica International Ltd, Allschwil. The trial plans to enroll 234 participants.