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ACTIVE NOT RECRUITING
NCT05570058
PHASE2

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

Sponsor: Redx Pharma Ltd

View on ClinicalTrials.gov

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.

Official title: A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients With Idiopathic Pulmonary Fibrosis

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2022-09-08

Completion Date

2025-01-09

Last Updated

2024-08-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

DRUG

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

Locations (31)

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