Back to resultsA Study to Investigate Leramistat in Patients With IPF
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Leramistat
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF
Eligibility Criteria
Inclusion Criteria: Diagnosis of IPF based on: a. ATS/ERS/JRS/ALAT guidelines (Raghu, 2022) as confirmed by the investigator based on chest high-resolution computed tomography (hrCT) scan taken within 3 years of Screening and, if available, surgical lung biopsy b. UIP or probable UIP hrCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to baseline (if indeterminate, hrCT findings of IPF may be confirmed locally by historical biopsy). Has an FVC ≥45% of predicted. Has a DLCO corrected for hemoglobin ≥25% and ≤80% of predicted. Minimum distance on 6MWT of 150 meters. Has a FEV1/FVC ratio >0.70. If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1 Has a life expectancy of at least 12 months (in the opinion of the investigator). This list contains only key inclusion criteria. Exclusion Criteria: Emphysema ≥50% on hrCT or the extent of emphysema is greater than the extent of fibrosis according to the central reviewer's assessment from the most recent hrCT or if reported by the local reviewer. Any current malignancy or a history of malignancy within the previous 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. Abnormality in heart rate, blood pressure or 12-lead ECG at screening that in the opinion of the Investigator increases the risk of participating in the study. Significant history of drug allergy, including to leramistat or excipients, as determined by the Investigator. Allergic reaction, anaphylaxis, or other reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis or leukopenia) History of opportunistic, chronic, or recurrent infections. Participants with chronic obstructive pulmonary disease (COPD) or asthma that: require >2 maintenance therapies have experienced an exacerbation requiring hospitalization or systemic corticosteroids within 12 months prior to screening. This list contains only key exclusion criteria.
Sites / Locations
- UCSF Fresno
- University of California, San Francisco Medical Center
- National Jewish Health Main Campus
- MedStar Georgetown University Hospital
- US Associates in Research Inc
- GCP Clinical Research
- Southern Medical Research, LLC
- IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
- Benchmark Research - Covington - HyperCore - PPDS
- University of Maryland Medical Center
- Howard County Center for Lung and Sleep Medicine, LLC
- Reliant Medical Research
- Hudson County Clinical Trials Research Center
- Lovelace Scientific Resources Inc
- Duke University Medical Center
- Southeastern Research CenterRecruiting
- Medical University of South Carolina - PPDS
- Clinical Trials Center of Middle Tennessee
- Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
- University of Utah - PPDS
- Hopital Avicenne
- Hopital Nord AP-HM
- Hôpital Pasteur II
- Hôpital Européen Georges Pompidou
- Hopital Robert Schuman
- Zentralklinik Bad Berka GmbH
- Ruhrlandklinik
- IKF Pneumologie
- Klinikum der Johann-Wolfgang Goethe-Universitat
- Universitätsklinikum Gießen und Marburg GmbH
- Universitatsklinikum Halle (Saale)
- Klinikum Köln-Merheim
- Universitatsklinikum Leipzig
- Universitatsklinikum Schleswig-Holstein - Kiel
- University Hospital of Alexandroupolis
- Evangelismos General Hospital of Athens
- Sotiria Chest Hospital of Athens
- University General Hospital of Heraklion
- University General Hospital of Ioannina
- University General Hospital of Larissa
- Georgios Papanikolaou General Hospital of Thessaloniki
- Semmelweis Egyetem
- Mátrai Gyógyintézet
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Shamir Medical Center Assaf Harofeh
- Lady Davis Carmel Medical Center
- Rambam Medical Center - PPDS
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center - PPDS
- Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
- Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliero Universitaria Di Modena Policlinico
- Fondazione Policlinico Universitario A Gemelli-Rome
- Azienda Ospedaliera Universitaria Senese
- Hospital Puerta del Mar
- Hospital Clinico Universitario de Valencia
- Royal Brompton Hospital
- University College Hospital
- North Manchester General Hospital - PPDS
- Walsall Manor Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Leramistat
Placebo
Arm Description
Leramistat once daily
Placebo comparator
Outcomes
Primary Outcome Measures
Forced vital capacity (FVC)
Change from baseline in FVC versus placebo up to Week 12
Secondary Outcome Measures
% predicted FVC
Change from baseline in %FVC up to Week 12
%DLCO
Change from baseline in %DLCO up to Week 12
Acute exacerbations
Time to first acute exacerbation up to Week 12.
Forced expiratory volume
Forced expiratory volume in 1 second (FEV1)
Disease progression
Decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death.
Full Information
NCT ID
NCT05951296
First Posted
June 22, 2023
Last Updated
September 11, 2023
Sponsor
Modern Biosciences Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05951296
Brief Title
A Study to Investigate Leramistat in Patients With IPF
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of Leramistat in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modern Biosciences Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).
Detailed Description
This will be a Phase 2, double-blind, placebo-controlled, 2-arm, parallel-group, multi-centre study to investigate leramistat treatment of patients aged 40 years or older with IPF. The study is planned to consist of the following parts:
Screening period: 1 to 28 days (Weeks -4 to -1). Treatment period: a 12-week blinded, placebo-controlled treatment period (Weeks 1 to 12).
Follow up period: 56 days (Weeks 13 to 20). All participants will return for a follow-up visit 56 days after their final dose.
Randomization will be stratified by concomitant use of an approved anti-fibrotic drug (nintedanib or pirfenidone) at randomization versus no concomitant use of an approved anti-fibrotic drug at randomization.
Number of Participants: Approximately 150 participants will be enrolled and randomly assigned in a 2:1 ratio to receive either leramistat or matched placebo.
If the participant is receiving nintedanib or pirfenidone treatment, it should be stable for at least 8 weeks prior to study entry and be predicted to remain stable during the course of the study. The maximum duration of participation (including screening period and follow-up) is 24 weeks.
Data Monitoring/Other Committee: A DSMB has been appointed for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
IPF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Leramistat
Arm Type
Experimental
Arm Description
Leramistat once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
Leramistat
Intervention Description
Drug: Leramistat
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Description
Change from baseline in FVC versus placebo up to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
% predicted FVC
Description
Change from baseline in %FVC up to Week 12
Time Frame
12 Weeks
Title
%DLCO
Description
Change from baseline in %DLCO up to Week 12
Time Frame
12 Weeks
Title
Acute exacerbations
Description
Time to first acute exacerbation up to Week 12.
Time Frame
12 Weeks
Title
Forced expiratory volume
Description
Forced expiratory volume in 1 second (FEV1)
Time Frame
12 Weeks
Title
Disease progression
Description
Decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death.
Time Frame
12 Weeks
Other Pre-specified Outcome Measures:
Title
biomarkers in serum and plasma
Description
hsCRP
Time Frame
12 Weeks
Title
Plasma pharmacokinetics
Description
Plasma concentrations in ng/ml
Time Frame
12 Weeks
Title
Adverse effects
Description
Incidence and frequency of treatment-emergent adverse events
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of IPF based on: a. ATS/ERS/JRS/ALAT guidelines (Raghu, 2022) as confirmed by the investigator based on chest high-resolution computed tomography (hrCT) scan taken within 3 years of Screening and, if available, surgical lung biopsy b. UIP or probable UIP hrCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to baseline (if indeterminate, hrCT findings of IPF may be confirmed locally by historical biopsy).
Has an FVC ≥45% of predicted.
Has a DLCO corrected for hemoglobin ≥25% and ≤80% of predicted.
Minimum distance on 6MWT of 150 meters.
Has a FEV1/FVC ratio >0.70.
If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1
Has a life expectancy of at least 12 months (in the opinion of the investigator).
This list contains only key inclusion criteria.
Exclusion Criteria:
Emphysema ≥50% on hrCT or the extent of emphysema is greater than the extent of fibrosis according to the central reviewer's assessment from the most recent hrCT or if reported by the local reviewer.
Any current malignancy or a history of malignancy within the previous 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Abnormality in heart rate, blood pressure or 12-lead ECG at screening that in the opinion of the Investigator increases the risk of participating in the study.
Significant history of drug allergy, including to leramistat or excipients, as determined by the Investigator.
Allergic reaction, anaphylaxis, or other reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis or leukopenia)
History of opportunistic, chronic, or recurrent infections.
Participants with chronic obstructive pulmonary disease (COPD) or asthma that:
require >2 maintenance therapies
have experienced an exacerbation requiring hospitalization or systemic corticosteroids within 12 months prior to screening.
This list contains only key exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operations
Phone
+44 (0)207 444 0066
Email
ist07@istesso.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
General Information
Phone
+44 (0)207 444 0066
Email
info@istesso.co.uk
Facility Information:
Facility Name
UCSF Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701-2302
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-2204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
National Jewish Health Main Campus
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206-2761
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
US Associates in Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GCP Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-3589
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Southern Medical Research, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201-8334
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303-3432
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Benchmark Research - Covington - HyperCore - PPDS
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-2353
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Howard County Center for Lung and Sleep Medicine, LLC
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044-3081
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Reliant Medical Research
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605-2058
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hudson County Clinical Trials Research Center
City
Union City
State/Province
New Jersey
ZIP/Postal Code
07087-3375
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lovelace Scientific Resources Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5129
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4029
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8900
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trials Center of Middle Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067-5663
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2073
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Utah - PPDS
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108-1257
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hopital Avicenne
City
Bobigny
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Nord AP-HM
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Pasteur II
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Robert Schuman
City
Vantoux
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Ruhrlandklinik
City
Essen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
IKF Pneumologie
City
Frankfurt am Main
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum der Johann-Wolfgang Goethe-Universitat
City
Frankfurt am Main
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Köln-Merheim
City
Köln
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Schleswig-Holstein - Kiel
City
Lübeck
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupoli
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Evangelismos General Hospital of Athens
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Sotiria Chest Hospital of Athens
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
University General Hospital of Heraklion
City
Heraklion
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
University General Hospital of Ioannina
City
Ioánnina
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
University General Hospital of Larissa
City
Larisa
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Georgios Papanikolaou General Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Mátrai Gyógyintézet
City
Gyöngyös
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Shamir Medical Center Assaf Harofeh
City
Be'er Ya'aqov
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Rambam Medical Center - PPDS
City
Haifa
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Kaplan Medical Center
City
Reẖovot
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Tel Aviv Sourasky Medical Center - PPDS
City
Tel Aviv-Yafo
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria Di Modena Policlinico
City
Modena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Policlinico Universitario A Gemelli-Rome
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Hospital Puerta del Mar
City
Cadiz
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University College Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
North Manchester General Hospital - PPDS
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Walsall Manor Hospital
City
Walsall
Country
United Kingdom
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate Leramistat in Patients With IPF
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