C21 in IPF
Research type
Research Study
Full title
A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis
IRAS ID
282448
Contact name
Joanna Porter
Contact email
Sponsor organisation
Vicore Pharma AB
Eudract number
2020-000822-24
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis.
Primary Objective to investigate the safety of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF.
Secondary Objectives to evaluate:
• The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 24 weeks
• The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 36 weeks
• The pharmacokinetic (PK) profile of C21 200 mg daily dose (100 mg b.i.d.) after multiple dosingExploratory Objectives: To investigate a range of laboratory parameters as potential biomarkers of inflammation, proliferation and fibrosis following oral administration of C21 200 mg daily dose (100 mg b.i.d.).
This is an multi-centre, open-label, single-arm trial investigating the safety and efficacy of C21 in which subjects with IPF will be treated for a maximum of 36 weeks. In total, approximately 60 subjects will be recruited at trial sites in Europe. To ensure careful and ongoing evaluation of the individual risk/benefit profiles, each subject will undergo a medical evaluation by the investigator at the end of every 12-week treatment period, where the investigator will evaluate if continuation into the next 12-week treatment period is considered safe for the individual subject.
Eligibility criteria: Diagnosis of IPF within 3 years prior to visit 1, age ≥40 years, FVC ≥80% predicted at visit 1, FEV1/FVC ratio ≥0.7 prebonchodilator at visit 1,oxygen saturation (Sp02) >85% by pulse oximetry while breathing ambient air at rest at visit 1, diffuse capacity for carbon monoxide >30%, High resolution computed tomography within 36 months prior to visit 1.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0138
Date of REC Opinion
6 Jul 2020
REC opinion
Further Information Favourable Opinion