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RXC007 for Idiopathic Pulmonary Fibrosis
Study Summary
This trial tests a drug to find out if it's safe and tolerable when used alone or with other drugs over 12 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am being treated for IPF with medications not specifically approved for it.I do not have conditions like severe lung or heart issues that make bronchoscopy unsafe for me.I stopped taking nintedanib or pirfenidone for my IPF more than 4 weeks ago.I have been on a stable dose of nintedanib or pirfenidone for my IPF for at least 4 weeks.I have not had a lung infection needing antibiotics in the last 4 weeks.Your lung function is at least 50% of what's expected for someone your age and gender, and it hasn't gotten significantly worse since your last check-up.I was diagnosed with IPF less than 5 years ago.I have not taken nintedanib or pirfenidone in the last 3 weeks.Your lung function test shows that you have trouble breathing out.The amount of emphysema in your lungs is more than fibrosis, as seen in high-resolution CT scans reviewed by experts.I am between 40 and 80 years old.Your lung function test (DLco, Hb-adjusted) at screening needs to be at least 30%.I need oxygen for more than 15 hours a day.I have a diagnosed connective-tissue disease or autoimmune-related lung disease.I have had a sudden worsening of my lung condition in the last 6 months.Your lung scan shows patterns that match a specific lung disease called IPF.My condition is expected to limit my life to less than 12 weeks.
- Group 1: Cohort 1B
- Group 2: Cohort 3B
- Group 3: Cohort 2
- Group 4: Cohort 1
- Group 5: Cohort 3
- 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
Does this investigation include geriatric patients?
"As stipulated by the criteria, individuals between 40 and 80 years old are eligible to join this clinical trial."
What risk do participants face in Cohort 3B?
"With Phase 2 trials being limited to safety data, Cohort 3B achieved a score of 2. As yet, there is no efficacy evidence available for this drug candidate."
How many participants are being monitored in this experiment?
"Affirmative. Clinicaltrials.gov contains data that suggests this medical trial is actively recruiting participants, having first been published on September 8th 2022 and last modified on June 28th 2023. Currently, 64 patients need to be enrolled from 37 separate clinical sites."
How many venues are testing this experiment?
"Currently, 37 distinct sites are running this clinical trial. These range from Philadelphia to Houston, and even Klagenfurt. It is recommended that you select a location closest to your residence in order to reduce the burden of travelling if accepted into the program."
Does this research initiative currently have open enrollment?
"Affirmative. According to the available statistics on clinicaltrials.gov, this study is still actively recruiting volunteers and has done so since September 8th 2022 when it was initially posted. The trial requires 64 participants across 37 medical centres and its data was last revised on June 28th 2023."
What is the ultimate goal of this research project?
"According to Redx Pharma Plc, the primary outcomes evaluated over a 12-week timeframe are changes in vital sign values from Day 1. Secondary endpoints that will be measured include Vz/F for RXC007, AUCss of RXC007 in plasma, and FVC relative to baseline at 12 weeks (as assessed by central review)."
Am I eligible to be a volunteer for this research project?
"This experiment is enlisting 64 individuals aged 40 to 80 suffering from idiopathic pulmonary fibrosis. These participants must meet the following criteria: be of age ≥40 and ≤80; have a diagnosis within 5 years prior to screening that has been confirmed by independent central imaging review; possess an FVC % predicted score ≥50%; display DLco (Hb-adjusted) at screening of ≥30%; patients on treatment for IPF with nintedanib or pirfenidone can apply after three months on stable dosage, while those who were previously treated should ensure there is a washout period of four weeks before screening occurs"
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