RXC007 for Idiopathic Pulmonary Fibrosis

Recruiting at 38 trial locations

Overseen By Emma McMurty, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Redx Pharma Ltd

Must be taking: Nintedanib, Pirfenidone

Disqualifiers: Connective-tissue disease, Emphysema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests RXC007, a new drug, for safety and side effects in patients with Idiopathic Pulmonary Fibrosis (IPF). Researchers will measure the drug levels in the blood and its impact on disease markers.

Do I need to stop my current medications to join the trial?

If you are currently taking nintedanib or pirfenidone for IPF, you can continue as long as you've been on a stable dose for at least 4 weeks before screening. If you previously took these medications but are not currently on them, you need a 4-week break before screening. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Research Team

Toby Maher

Principal Investigator

University of Southern California, USA

Philip Molyneaux, MD

Principal Investigator

Royal Brompton & Harefield NHS Foundation Trust

Eligibility Criteria

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.

Inclusion Criteria

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.

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.

Exclusion 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 have not had a lung infection needing antibiotics in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive RXC007 or placebo for 12 weeks, with pharmacokinetic and pharmacodynamic assessments

12 weeks

Multiple visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• RXC007

Trial Overview 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.

Participant Groups

Group I: Expansion Cohort Experimental Treatment 2 Interventions

12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing

Group II: Cohort 2 Experimental Treatment 2 Interventions

12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing

Group III: Cohort 1 Experimental Treatment 2 Interventions

12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing

Who Is Running the Clinical Trial?

Redx Pharma Ltd

Lead Sponsor

Trials

5

Recruited

250+

Redx Pharma Plc

Lead Sponsor

Trials

5

Recruited

250+

Simbec-Orion Group

Industry Sponsor

Trials

10

Recruited

690+

Simbec Research

Industry Sponsor

Trials

41

Recruited

2,000+