Clinical trial NCT05951296: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: IPF
Lead sponsor: Modern Biosciences Ltd
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Has an FVC ≥45% of predicted.
3. Has a DLCO corrected for hemoglobin ≥25% and ≤80% of predicted.
4. Minimum distance on 6MWT of 150 meters.
5. Has a FEV1/FVC ratio \>0.70.
6. 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
7. Has a life expectancy of at least 12 months (in the opinion of the investigator).

   * This list contains only key inclusion criteria.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Significant history of drug allergy, including to leramistat or excipients, as determined by the Investigator.
5. Allergic reaction, anaphylaxis, or other reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis or leukopenia)
6. History of opportunistic, chronic, or recurrent infections.
7. 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.

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: Adverse effects
timeFrame: 12 Weeks
Locations:
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Denver
country: United States
facility: National Jewish Health Main Campus
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Miami
country: United States
facility: US Associates in Research Inc
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Macon
country: United States
facility: Southern Medical Research, LLC
state: Georgia
city: Chicago
country: United States
facility: GenHarp Clinical Solutions
state: Illinois
city: Muncie
country: United States
facility: IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
state: Indiana
city: Covington
country: United States
facility: Benchmark Research - Covington - HyperCore - PPDS
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Columbia
country: United States
facility: Howard County Center for Lung and Sleep Medicine, LLC
state: Maryland
city: Columbia
country: United States
facility: Howard County Center for Lung and Sleep Medicine, LLC
state: Maryland
city: Union City
country: United States
facility: Hudson County Clinical Trials Research Center
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Dallas
country: United States
facility: Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - PPDS
state: Utah
city: Marseille
country: France
facility: Hopital Nord AP-HM
city: Nice
country: France
facility: Hôpital Pasteur II
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Vantoux
country: France
facility: Hopital Robert Schuman
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Essen
country: Germany
facility: Ruhrlandklinik
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Halle
country: Germany
facility: Universitatsklinikum Halle (Saale)
city: Köln
country: Germany
facility: Klinikum Köln-Merheim
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Lübeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein - Kiel
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Diseases Thoracos of Athens "Sotiria"
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina
city: Larisa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloníki
country: Greece
facility: Georgios Papanikolaou General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center - PPDS
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital - PPDS
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
Study officials:
References: