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Monoclonal Antibodies
Leramistat for Idiopathic Pulmonary Fibrosis
Phase 2
Recruiting
Research Sponsored by Modern Biosciences Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 an FVC ≥45% of predicted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial compares the effects of taking a drug vs no drug on people 40+ w/IPF over 12 weeks.
Who is the study for?
This trial is for adults over 40 with idiopathic pulmonary fibrosis (IPF), able to walk at least 150 meters, and on stable anti-fibrotic treatment if any. They should have a certain level of lung function and life expectancy of more than a year. Excluded are those with significant heart issues, drug allergies including to leramistat, severe emphysema or COPD, recent cancer except some skin cancers, or history of serious infections.Check my eligibility
What is being tested?
The study tests the effects of Leramistat against a placebo in treating IPF over 12 weeks. Participants will take daily oral doses to see if there's an improvement in their condition compared to those taking the non-active placebo.See study design
What are the potential side effects?
While specific side effects for Leramistat aren't listed here, common ones may include digestive discomforts like nausea or diarrhea, potential liver enzyme changes, fatigue or possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable dose of nintedanib or pirfenidone for at least 8 weeks.
Select...
My lung function is at least 45% of what is expected.
Select...
I can walk at least 150 meters in 6 minutes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Forced vital capacity (FVC)
Secondary outcome measures
% predicted FVC
%DLCO
Acute exacerbations
+2 moreOther outcome measures
Adverse effects
Plasma pharmacokinetics
biomarkers in serum and plasma
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LeramistatExperimental Treatment1 Intervention
Leramistat once daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo comparator
Find a Location
Who is running the clinical trial?
Modern Biosciences LtdLead Sponsor
4 Previous Clinical Trials
511 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with IPF based on a detailed lung scan or biopsy.I use more than two treatments regularly for my COPD or asthma.Your lung function test shows a specific measurement that is not within the expected range.I have COPD or asthma and needed hospital care or steroids in the last year.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that was treated.I have been on a stable dose of nintedanib or pirfenidone for at least 8 weeks.My lung function is at least 45% of what is expected.You have had severe allergic reactions or serious skin reactions in the past.I have a history of frequent or long-lasting infections.More than half of my lungs show signs of emphysema on a high-resolution CT scan.I can walk at least 150 meters in 6 minutes.Your FEV1/FVC ratio is greater than 0.70.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Leramistat
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still patient positions available for this investigation?
"It appears that this clinical trial, which was initially posted on July 1st 2023 and last edited on July 10th 2023, is not looking for participants at the present time. Nevertheless, there are 423 other trials actively recruiting patients currently."
Answered by AI
What evidence has been established to validate the safety of MBS2320?
"MBS2320's safety was rated at a 2 because it is only in Phase 2 of testing, so there are limited details to support its efficacy but some data that confirms its security."
Answered by AI
What number of medical facilities are actively executing this trial?
"This trial is currently being conducted at 60 sites, which include San Francisco, Denver and Washington in addition to other locales. If you are interested in joining this study, it would be best to select a nearby centre for your convenience."
Answered by AI
Who else is applying?
What site did they apply to?
Benchmark Research - Covington - HyperCore - PPDS
Hudson County Clinical Trials Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve not yet tried to take a medication to delay my Ipf and extend my life. I want to try one or more.
PatientReceived 1 prior treatment
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