Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
NCT ID: NCT05570058
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2022-09-08
2025-01-09
Brief Summary
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Detailed Description
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The main objectives of this study are as follows:
* To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of RXC007 when it is administered as twice daily doses over a period of up to 12 weeks (84 days).
* To investigate the concentration of RXC007 (how much drug is in your blood), how this changes over a period of time and to evaluate whether there are differences in the concentration between different dose strengths of RXC007.
* To investigate the effect of RXC007 on the body (known as pharmacodynamics) by analysing the levels of certain biomarkers in the body and to assess the effect of RXC007 on markers associated with Idiopathic Pulmonary Fibrosis (IPF). Biomarkers are markers within the body such as a molecule or compound made by cells in the body, which can be measured and used to identify a particular disease.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing
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
Cohort 2
12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing
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
Expansion Cohort
12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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)
40 Years
80 Years
ALL
No
Sponsors
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Simbec-Orion Group
INDUSTRY
Redx Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Molyneaux, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Toby Maher, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California, USA
Locations
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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
Countries
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Other Identifiers
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RXC007/0002
Identifier Type: -
Identifier Source: org_study_id
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