A Phase 2 study of RXC007 in patients with IPF
Research type
Research Study
Full 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
IRAS ID
1005138
Contact name
Jane Robertson
Contact email
Sponsor organisation
Redx Pharma Plc
Eudract number
2022-000498-15
ISRCTN Number
ISRCTN60385283
Clinicaltrials.gov Identifier
N/A
Research summary
The purpose of this study is to investigate the study drug RXC007. 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 levels of RXC007 in the blood, how this changes over a period of time and to evaluate whether there are differences in the levels 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).This study will comprise of 3 main study groups and 2 additional sub-study groups. The main study will consist of 3 planned groups of 16 patients with IPF: each group investigating a different dose strength of RXC007 starting at the lowest planned dose in Group 1 to the highest planned dose in Group 3. The sub-study will consist of 2 groups of up to 8 patients with IPF (each group respectively evaluating the same dose of RXC007 as evaluated in Group 1 and 3 of the main study). The sub-study groups will include evaluations of the levels of RXC007 found in fluid collected from the lungs.
The purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in the development of the study drug RXC007 and to provide early data as to the potential effectiveness of RXC007 as a treatment for IPF.
REC name
Wales REC 2
REC reference
22/WA/0122
Date of REC Opinion
14 Jun 2022
REC opinion
Further Information Favourable Opinion