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RXC007 for Idiopathic Pulmonary Fibrosis
Phase 2
Recruiting
Led By Philip Molyneaux, MD
Research Sponsored by Redx Pharma Plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of IPF within 5 years of Screening based on the modified ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and management of IPF (Raghu et al, 2018) and confirmed on independent central imaging review
Aged ≥40 to 80 years at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 40-80 with Idiopathic Pulmonary Fibrosis (IPF) diagnosed within the last 5 years, having stable lung function and not on certain IPF treatments. Participants can be on nintedanib or pirfenidone if doses have been stable for at least a month. Exclusions include severe other diseases, recent infections, continuous oxygen need over 15 hours/day, and specific contra-indications to bronchoscopy.Check my eligibility
What is being tested?
The study tests RXC007's safety and effects over 12 weeks in people with IPF, alone or alongside existing treatments like nintedanib or pirfenidone. It aims to understand how the body processes RXC007 and its impact on IPF symptoms compared to a placebo.See study design
What are the potential side effects?
While specific side effects of RXC007 are not listed here, common risks may include reactions at the injection site, gastrointestinal issues, potential liver enzyme changes, fatigue or respiratory symptoms which will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with IPF less than 5 years ago.
Select...
I am between 40 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs
Electrocardiogram
Manometry
+1 moreSecondary outcome measures
% predicted and absolute change from baseline in carbon monoxide diffusion capacity (DLCO)
Vital capacity
Plasma
+8 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 3BExperimental Treatment2 Interventions
6:2 (RXC007 : Placebo) Dose level 3; 12 weeks (28 days) dosing, Pre- and on-treatment bronchoscopy
Group II: Cohort 3Experimental Treatment2 Interventions
12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing
Group III: Cohort 2Experimental Treatment2 Interventions
12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing
Group IV: Cohort 1BExperimental Treatment2 Interventions
6:2 (RXC007 : Placebo) Dose level 1; 12 weeks (28 days) dosing, Pre- and on-treatment bronchoscopy
Group V: Cohort 1Experimental Treatment2 Interventions
12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RXC007
2021
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Simbec ResearchIndustry Sponsor
40 Previous Clinical Trials
1,950 Total Patients Enrolled
1 Trials studying Fibrosis
90 Patients Enrolled for Fibrosis
Redx Pharma PlcLead Sponsor
4 Previous Clinical Trials
206 Total Patients Enrolled
1 Trials studying Fibrosis
90 Patients Enrolled for Fibrosis
Philip Molyneaux, MDPrincipal InvestigatorRoyal Brompton & Harefield NHS Foundation Trust
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1B
- Group 2: Cohort 3B
- Group 3: Cohort 2
- Group 4: Cohort 1
- Group 5: Cohort 3
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.
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