RXC007 for Idiopathic Pulmonary Fibrosis

Not currently recruiting at 41 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RXC007 for people with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. Researchers aim to determine the safety and tolerability of RXC007, both alone and with other IPF treatments like nintedanib or pirfenidone. The trial includes different groups to test various doses of RXC007 over 12 weeks. It seeks participants diagnosed with IPF in the last 5 years who have been on a stable treatment plan with nintedanib or pirfenidone, or who are not currently on any IPF treatment. As a Phase 2 trial, this research measures how well RXC007 works in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective IPF treatment.

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.

Is there any evidence suggesting that RXC007 is likely to be safe for humans?

Research has shown that RXC007 was well-tolerated in past studies. In earlier tests with healthy volunteers, RXC007 did not raise major safety concerns, and participants did not experience significant side effects. This is promising as it moves into studies with patients who have idiopathic pulmonary fibrosis. While the current study continues to assess safety, earlier results suggest that RXC007 is relatively safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for idiopathic pulmonary fibrosis, which often includes antifibrotic drugs like pirfenidone and nintedanib, RXC007 acts on different pathways. Researchers are excited about RXC007 because it targets the Rho-associated protein kinase (ROCK) pathway, which plays a crucial role in tissue fibrosis and inflammation. This unique mechanism may offer new hope for slowing disease progression and improving lung function. Additionally, RXC007 has the potential to provide a more targeted approach, potentially reducing side effects associated with current treatments.

What evidence suggests that RXC007 might be an effective treatment for idiopathic pulmonary fibrosis?

Studies have shown that RXC007 might help treat Idiopathic Pulmonary Fibrosis (IPF). In lab tests with animals, RXC007 reduced thickening and scarring in the lungs and skin, which is promising for IPF, a condition where the lungs become thick and scarred. Early human trials suggested that RXC007 is well-tolerated, meaning it doesn't cause serious side effects. Although researchers are still learning how well it works in people, these early results encourage further research. Participants in this trial will receive RXC007 or a placebo in different dosing cohorts to further evaluate its effectiveness and safety. ^{1 2 5 6 7}

Who Is on the Research Team?

Toby Maher

Principal Investigator

University of Southern California, USA

Philip Molyneaux, MD

Principal Investigator

Royal Brompton & Harefield NHS Foundation Trust

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. redxpharma.com redxpharma.com/our-pipeline/zelasudil/

Zelasudil (RXC007, ROCK2 selective) - Redx Pharma Redx presents encouraging signal searching data for zelasudil (RXC007) as a well-tolerated treatment for Idiopathic Pulmonary Fibrosis at ERS · ERS 2025 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05570058

Study Details | NCT05570058 | Assess the Safety, ... The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12 weeks (84 days), alone and in combination with nintedanib or ...

3. firstwordpharma.com firstwordpharma.com/story/6227492

Redx presents encouraging signal searching data for ... Redx presents encouraging signal searching data for zelasudil (RXC007) as a well-tolerated treatment for Idiopathic Pulmonary Fibrosis at ERS.

4. isrctn.com isrctn.com/ISRCTN60385283

ISRCTN60385283: A study to investigate the safety, ... A study to investigate the safety, tolerability, and potential effect of RXC007 in patients with idiopathic pulmonary fibrosis.

5. rarediseaseadvisor.com rarediseaseadvisor.com/news/rxc007-shows-antifibrotic-effects-in-preclinical-models-ipf/

RXC007 Shows Antifibrotic Effects in Preclinical Models of ... Oral RXC007 reduced skin thickness, fibrosis, and collagen deposition in the skin and lungs of mice. In addition, data from a phase 1 study in ...

6. redxpharma.com redxpharma.com/wp-content/uploads/2022/05/Redx-Pharma-Redx-Presents-Encouraging-Phase-1-Safety-Data-for-RXC007.pdf

of 2 - Redx Pharma Importantly, this data supports progressing into Phase 2 studies later this year to assess the safety and efficacy of RXC007 in patients with ...

7. rarediseaseadvisor.com rarediseaseadvisor.com/news/redx-pharma-study-rxc007-safety-efficacy-activity-ipf/

New Study Launched on RXC007 Safety, Efficacy, Activity ... Study to assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of RXC007 in idiopathic pulmonary fibrosis. ClinicalTrials.