Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis

NCT05570058 · tracked via the Priya Life Science Italy tracker

Sponsor

Redx Pharma Ltd

Phase

Phase 2

Started

2022-09-08

Last updated

2024-08-23

Condition(s) studied

IPFFibrosis

Investigational drug(s) / intervention(s)

RXC007Placebo

RXC007: RXC007 will be administered in the form of oral capsules at 3 potential dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and the Expansion cohort will receive RXC007. The Dosage regimen is BID or QD.

Placebo: The placebo will be administered in the form of oral capsules at each dose level to 4 of the 16 participants within cohorts 1, 2 and the Expansion cohort. The Dosage regimen is BID or QD

Study summary

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 pirfenidone.

Eligibility

Sex

ALL

Min age

40 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Aged ≥40 to 80 years at the time of signing the informed consent. * 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. * Combination of HRCT pattern, as assessed by central reviewers, consistent with diagnosis of IPF (see the modified ATS/ERS/JRS/ALAT IPF guidelines \[Raghu et al, 2018\]). * FVC % predicted ≥50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomisation, as determined by the Investigator. * DLco (Hb-adjusted) at screening ≥30%. * In the main study, participants receiving treatment for IPF with nintedanib or pirfenidone are allowed if on treatment for at least 3 months and on a stable dose for at least 4 weeks prior to Screening and during Screening. * In patients who are not on any treatment for IPF but have previously received nintedanib or pirfenidone, there needs to be a washout period ≥4 weeks prior to Screening. * No clinically significant abnormalities, in the opinion of the investigator, in vital signs (e.g., blood pressure, pulse rate, respiration rate, oral temperature) within 28 days before first dose of IMP. Exclusion Criteria: * Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication. * FEV1/FVC ratio \<0.7 at Screening, pre-bronchodilator use. * Lower respiratory tract infection requiring antibiotics within 4 weeks of Screening or during Screening. 4\. The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans. * Need for continuous oxygen supplementation, defined as \>15 hours/day. * Acute IPF exacerbation within 6 months of Screening or during Screening. * Clinical diagnosis of any connective-tissue disease (including, but not limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator applying the recent ERS/ATS research statement \[Fischer et al 2015\]. Note: Serological testing is not needed if not clinically indicated. * Disease other than IPF with a life expectancy of less than 12 weeks. Additional exclusion criteria for the Translational Science Sub Study * Participants with any contra-indication to bronchoscopy and alveolar lavage including tracheal stenosis, pulmonary hypertension, severe hypoxia, or hypercapnia. * Patients in the sub study are not permitted to receive nintedanib or pirfenidone within 3 weeks of randomisation and throughout the Treatment period. (Note: background IPF treatment should not be stopped for the purpose of eligibility)

Primary outcome measure(s)

Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs — From Day 1 to post-study follow up visit (12 weeks)
The primary endpoints of the study include the incidence and severity of AEs and SAEs
Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit. — From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to 12 weeks of treatment — From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the vital signs parameters (systolic/diastolic blood pressure, pulse rate, respiration rate, oral body temperature) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) from first dose on Day 1 up to completion of the post-study visit. — From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) as defined in the study protocol following first dose administration on Day 1 up to 12 weeks of treatment

Trial sites (31)

Facility	City	Region
Medical University of Vienna	Vienna	Austria
E PNE UZ Leuven	Leuven	Belgium
CHU De Liège	Liège	Belgium
Pneumologicka klinika 1.LF UK a	Prague	Czechia
Azienda Ospedaliero-Universitaria "Ospedali-Riuniti" di Ancona	Ancona	Italy
Azienda Ospedaliero Universitaria Policlinico ''G.Rodolico-San Marco''	Catania	Italy
Colonello D'avanzo Hospital	Foggia	Italy
PO Vito Fazzi	Lecce	Italy
Ospedale S. Giuseppe Milano	Milan	Italy
Azienda Ospedaliera Universitaria of Modena	Modena	Italy
Fondazione Policlinico Universitario A. Gemelli	Roma	Italy
Azienda Ospedaliera Universitaria Integrata Verona	Verona	Italy
University Clinical Centre in Gdansk	Gdansk	Poland
Barlicki University Hospital	Lodz	Poland
Institute of Tuberculosis and Lung Diseases in Warsaw	Warsaw	Poland
Policlinica Barcelona	Barcelona	Spain
Hospital Universitario Clínic de Barcelona	Barcelona	Spain
L'Hospital Universitari de Bellvitge	Barcelona	Spain
Hospital Universitario La Paz	Madrid	Spain
Hospital Universitario Central de Asturias	Oviedo	Spain
Hospital Universitario Marqués de Valdecilla	Santander	Spain
Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	Spain
University Hospital of Geneve	Geneva	Switzerland
Belfast City Hospital	Belfast	United Kingdom
Queen Elizabeth Hospital	Birmingham	United Kingdom
Royal Papworth Hospital NHSFT	Cambridge	United Kingdom
Royal Infirmary of Edinburgh	Edinburgh	United Kingdom
Guy's Hospital	London	United Kingdom
Royal Brompton Hospital	London	United Kingdom
Altnagelvin Area Hospital	Londonderry	United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Trust	Oxford	United Kingdom

Other trials for the same condition

Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis Recruiting

Assessment of Self-Care in Patients With Idiopathic Pulmonary Fibrosis (IPF) Active, not recruiting

Diarrheal Adverse Events in Caucasian Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05570058 on ClinicalTrials.gov ↗ ← All trials in Italy