Idiopathic Pulmonary FibrosisPhase 2NCT05951296
A Study to Investigate Leramistat in Patients With IPF
A Phase 2 study testing Leramistat in people with Idiopathic Pulmonary Fibrosis, run by Modern Biosciences Ltd at 57 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Leramistat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 57 sitesin 9 countries
- Study dates
- 30 Aug 2023to 14 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
57 sites in 9 countries.
57 sites in 9 countries
United States21 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201-1544
GenHarp Clinical Solutions
Chicago, Illinois, 60649-4718
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland, 21044-3081
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland, 21045-5422
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana, 70433-2353
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
Dallas, Texas, 75246-2073
National Jewish Health Main Campus
Denver, Colorado, 80206-2761
Duke University Medical Center
Durham, North Carolina, 27710-4000
UCSF Fresno
Fresno, California, 93701-2302
Southern Medical Research, LLC
Macon, Georgia, 31201-8334
Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr
McKinney, Texas, 75069-1898
Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr
McKinney, Texas, 75069-1898
Reliant Medical Research
Miami, Florida, 33165
US Associates in Research Inc
Miami, Florida, 33175
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana, 47303-3432
University of Utah - PPDS
Salt Lake City, Utah, 84108-1257
GCP Clinical Research, LLC
Tampa, Florida, 33609-3589
GCP Clinical Research
Tampa, Florida, 33609-3589
Hudson County Clinical Trials Research Center
Union City, New Jersey, 07087-3375
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029
Germany8 sites
Zentralklinik Bad Berka GmbH
Bad Berka
Klinikum Köln-Merheim
Cologne
Ruhrlandklinik
Essen
IKF Pneumologie
Frankfurt am Main
Universitätsklinikum Gießen und Marburg GmbH
Giessen
Universitatsklinikum Halle (Saale)
Halle
Universitatsklinikum Leipzig
Leipzig
Universitatsklinikum Schleswig-Holstein - Kiel
Lübeck
Greece7 sites
University Hospital of Alexandroupolis
Alexandroupoli
Evangelismos General Hospital of Athens
Athens
General Hospital of Diseases Thoracos of Athens "Sotiria"
Athens
University General Hospital of Heraklion
Heraklion
University General Hospital of Ioannina
Ioannina
University General Hospital of Larissa
Larissa
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki
Italy5 sites
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania
Azienda Ospedaliera Universitaria Careggi
Florence
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena
Fondazione Policlinico Universitario A Gemelli-Rome
Roma
Azienda Ospedaliera Universitaria Senese
Siena
France4 sites
Hopital Nord AP-HM
Marseille
Hôpital Pasteur II
Nice
Hôpital Européen Georges Pompidou
Paris
Hopital Robert Schuman
Vantoux
Israel4 sites
Lady Davis Carmel Medical Center
Haifa
Rambam Medical Center - PPDS
Haifa
Kaplan Medical Center
Rehovot
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv
United Kingdom4 sites
Royal Brompton Hospital
London
University College Hospital
London
North Manchester General Hospital - PPDS
Manchester
Walsall Manor Hospital
Walsall
Hungary2 sites
Semmelweis Egyetem
Budapest
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár
Spain2 sites
Hospital Puerta del Mar
Cadiz
Hospital Clinico Universitario de Valencia
Valencia
About this study
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)
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).
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Leramistat, Placebo
- Keywords
- IPF
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeramistatDrug
Drug: Leramistat
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Leramistat | Experimental | Leramistat once daily Receives: Drug: Leramistat |
| Placebo | Placebo comparator | Placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
Change from baseline in FVC versus placebo up to Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start30 Aug 2023
- Primary completion27 Feb 2024
- Study completion14 Mar 2024
Why it stopped: Due to slow initial recruitment and a lack of confidence in our ability to complete recruitment within the forecasted timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modern Biosciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951296
- Sponsor's protocol ID
- IST-07
- Other IDs
- 2023-504418-30, 2023
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05951296
- Acronym / sponsor ID
- IST-07
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to slow initial recruitment and a lack of confidence in our ability to complete recruitment within the forecasted timeframe.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Modern Biosciences LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leramistat | Experimental | Drug: LeramistatLeramistat once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparator |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeramistatDrug: Leramistat | Drug | Leramistat |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Forced vital capacity (FVC)
Time frame: 12 weeks
Change from baseline in FVC versus placebo up to Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leramistat in people with Idiopathic Pulmonary Fibrosis, run by Modern Biosciences Ltd at 57 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Germany, Greece, Italy, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.