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Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238116
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Pulmocide Ltd

Tracking Information
First Submitted Date  ICMJE February 3, 2022
First Posted Date  ICMJE February 14, 2022
Last Update Posted Date May 10, 2024
Actual Study Start Date  ICMJE June 14, 2022
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2024)		 Number of Participants with Complete or Partial Overall Response [ Time Frame: up to 12 weeks (Day 84) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2022)		 Day 84 favorable overall response: being alive and having a complete or partial overall response at Day 84, as assessed by the Data Review Committee (DRC) [ Time Frame: 84 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2024)		 Time to Complete or Partial Overall Clinical Response [ Time Frame: up to 12 weeks (Day 84) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Official Title  ICMJE 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 (OPERA-T Study)
Brief Summary To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Refractory IPA
Intervention  ICMJE
  • Drug: PC945
    Sterile aqueous liquid for Nebulization
  • Drug: Placebo
    Sterile aqueous liquid for Nebulization
Study Arms  ICMJE
  • Experimental: PC945
    PC945 dose, administered via nebulizer, twice daily
    Intervention: Drug: PC945
  • Placebo Comparator: Placebo
    PC945-placebo administered via nebulizer, twice daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2022)		 123
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant has proven or probable IPA according to the modified 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.
  2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria:

  1. 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.
  2. Participant who has previously received PC945.
  3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
  4. Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chief Medical Officer +44 (0)203 763 9484 admin@pulmocide.com
Contact: Vice President of Clinical Development is +44 (0) 203 763 9484 admin@pulmocide.com
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   France,   Germany,   Greece,   Israel,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05238116
Other Study ID Numbers  ICMJE PC_ASP_006
2021-004554-32 ( EudraCT Number )
2024-511281-36 ( Registry Identifier: EU CT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Pulmocide Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pulmocide Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pulmocide Ltd
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP