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

    joanna.porter@ucl.ac.uk

  • 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 dosing

    Exploratory 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