Safety and Efficacy of PC945 in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis

Sponsor

Pulmocide Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05238116

Collaborator

(none)

123

Enrollment

Locations

Arms

17.5

Anticipated Duration (Months)

61.5

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Condition or Disease	Intervention/Treatment	Phase
Refractory IPA	Drug: PC945 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double Blind

Primary Purpose:

Treatment

Official Title:

A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis

Actual Study Start Date :

Jun 14, 2022

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PC945 PC945 dose, administered via nebulizer, twice daily	Drug: PC945 Sterile aqueous liquid for Nebulization
Placebo Comparator: Placebo PC945-placebo administered via nebulizer, twice daily	Drug: Placebo Sterile aqueous liquid for Nebulization

Arm

Intervention/Treatment

Experimental: PC945

PC945 dose, administered via nebulizer, twice daily

Drug: PC945

Sterile aqueous liquid for Nebulization

Placebo Comparator: Placebo

PC945-placebo administered via nebulizer, twice daily

Drug: Placebo

Sterile aqueous liquid for Nebulization

Outcome Measures

Primary Outcome Measures

Number of Participants with Complete or Partial Overall Response [up to 12 weeks]

Secondary Outcome Measures

Time to Complete or Partial Overall Clinical Response [up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant has proven or probable IPA according to the 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
Participant's IPA has an unfavorable response to adequate antifungal therapy.

Exclusion Criteria:

Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
Participant who has previously received PC945.
Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
Participant who is participating, or who is due to participate at any time during the study, in a therapeutic or diagnostic clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Indianapolis	Indiana	United States	46202
2	Clinical Research Site	Houston	Texas	United States	77032

Sponsors and Collaborators

Pulmocide Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pulmocide Ltd

ClinicalTrials.gov Identifier:

NCT05238116

Other Study ID Numbers:

PC_ASP_006
2021-004554-32

First Posted:

Feb 14, 2022

Last Update Posted:

Jun 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pulmocide Ltd

Refractory IPA

invasive pulmonary aspergillosis

Additional relevant MeSH terms:

Aspergillosis

Pulmonary Aspergillosis

Invasive Pulmonary Aspergillosis

Study Results

No Results Posted as of Jun 15, 2022