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LTP001 for Idiopathic Pulmonary Fibrosis
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female participants at least 40 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 12, 16, 20, 26
Awards & highlights
Study Summary
This trial will test new treatments for idiopathic pulmonary fibrosis, without patients or investigators knowing which treatments are being used. Safety, efficacy, and tolerability will be measured.
Who is the study for?
This trial is for adults at least 40 years old with idiopathic pulmonary fibrosis (IPF), a type of lung scarring. Participants must have certain levels of lung function and be on stable IPF medication if applicable. They shouldn't have major airway blockage, significant emphysema, connective tissue disease, or recent worsening of their condition.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of LTP001 against a placebo while all participants continue receiving standard care for IPF. It's blinded so neither the researchers nor participants know who gets the real treatment versus placebo, and people are chosen randomly to receive one or the other.See study design
What are the potential side effects?
While specific side effects aren't listed here, investigational drugs like LTP001 can cause unexpected reactions due to their newness. Placebos typically don't cause side effects but taking part in trials may involve risks like allergic reactions or drug interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 8, 12, 16, 20, 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, 16, 20, 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted
Secondary outcome measures
Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC)
Change from baseline to the end of treatment epoch in 6-minute walk distance
Change from baseline to the end of treatment epoch in DLCO
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks
Group II: LTP001Experimental Treatment2 Interventions
Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Standard of Care (SoC)
2011
Completed Phase 4
~2200
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,198,215 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
122 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a connective tissue disease.I am 40 years old or older.Your lung function should be at least 25% of what is expected for someone your age and size.I have been on a steady dose of nintedanib or pirfenidone for at least 8 weeks.I have breathing issues due to airway obstruction or respond to inhalers.You have less than 10% fibrosis on the lung scan done during screening.You have more than 20% emphysema on a specific type of lung scan.My lung condition has gotten significantly worse in the last 3 months.Your predicted forced vital capacity (FVC) is at least 45%.You have been diagnosed with IPF using specific medical guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: LTP001
- Group 2: Placebo
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.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT05497284 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies for this clinical trial?
"This medical research project is currently searching for participants. Information regarding the trial, which was initially posted on November 10th 2022 and recently edited by on February 23rd 2023, can be found on clinicaltrials.gov."
Answered by AI
Has the drug LTP001 been officially endorsed by the FDA?
"The safety of LTP001 was assessed to be a score 2 out of 3, as the drug has only undergone Phase 2 trials with preliminary evidence supporting its safety but no data confirming efficacy."
Answered by AI
How many individuals have been included in this trial to date?
"Affirmative. As per the information hosted on clinicaltrials.gov, this medical experiment is currently searching for qualified participants and was initially shared online on November 10th 2022. The trial requires 94 individuals across 3 separate sites to be enrolled in it, with its latest update occurring on February 23rd 2023."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
i have tried nintedanib but condition does not improve. i have significant covid fibrosis from 11/20. my overall lung function continues to deteriorate. currently being followed by Dr Hamblin at KU.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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