IPFPhase 2NCT05570058
Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
A Phase 2 study testing RXC007 in people with IPF and Fibrosis, run by Redx Pharma Ltd at 31 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- RXC007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 8 Sep 2022to 9 Jan 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥40 to 80 years at the time of signing the informed consent.
- 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.
Who cannot join
- Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication.
- 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.
Show all 11Show fewer
- 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.
- Additional exclusion criteria for the Translational Science Sub Study
- 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)
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
Italy8 sites
Azienda Ospedaliero-Universitaria "Ospedali-Riuniti" di Ancona
Ancona, 60126
Azienda Ospedaliero Universitaria Policlinico ''G.Rodolico-San Marco''
Catania, 95123
Colonello D'avanzo Hospital
Foggia, 71122
PO Vito Fazzi
Lecce, 73100
Ospedale S. Giuseppe Milano
Milan, 20123
Azienda Ospedaliera Universitaria of Modena
Modena, 41124
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
United Kingdom8 sites
Belfast City Hospital
Belfast, BT97AB
Queen Elizabeth Hospital
Birmingham, B15 2GW
Royal Papworth Hospital NHSFT
Cambridge, CB2 0AY
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Guy's Hospital
London, SE1 9RT
Royal Brompton Hospital
London, SW3 6HP
Altnagelvin Area Hospital
Londonderry, BT476SB
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, OX7 3LE
Spain7 sites
Policlinica Barcelona
Barcelona, 08006
Hospital Universitario Clínic de Barcelona
Barcelona, 08036
L'Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Poland3 sites
University Clinical Centre in Gdansk
Gdansk, 01-138
Barlicki University Hospital
Lodz
Institute of Tuberculosis and Lung Diseases in Warsaw
Warsaw, 01-138
About this study
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
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.
Read the detailed description
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 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.
- Being tested
- RXC007, Placebo
- Keywords
- Lung, Respiratory, Fibrosis, IPF
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXC007Drug
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.
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing Receives: Drug: RXC007; Drug: Placebo |
| Cohort 2 | Experimental | 12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing Receives: Drug: RXC007; Drug: Placebo |
| Expansion Cohort | Experimental | 12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing Receives: Drug: RXC007; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs
The primary endpoints of the study include the incidence and severity of AEs and SAEs
Measured: From Day 1 to post-study follow up visit (12 weeks)
Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.
This primary endpoint will report the number of participants within all cohorts of study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
Measured: From Day 1 to post-study follow up visit (12 weeks)
Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to 12 weeks of treatment
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the vital signs parameters (systolic/diastolic blood pressure, pulse rate, respiration rate, oral body temperature) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
Measured: From Day 1 to post-study follow up visit (12 weeks)
Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) from first dose on Day 1 up to completion of the post-study visit.
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) as defined in the study protocol following first dose administration on Day 1 up to 12 weeks of treatment
Measured: From Day 1 to post-study follow up visit (12 weeks)
Secondary outcomes (11)
Pharmacokinetic Parameters - Maximum plasma concentration (Cmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Minimum observed plasma concentration (Cmin)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the minimum observed concentration (Cmin) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Time to maximum observed concentration (Tmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Terminal elimination half-life (t1/2)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of RXC007 in plasma for all cohorts
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Elimination rate constant (λz)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the elimination rate constant (λz) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Total apparent clearance following extravascular administration (CL/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the total apparent clearance following extravascular administration (CL/F) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Apparent volume of distribution following extravascular administration (Vz/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the apparent volume of distribution following extravascular administration (Vz/F) of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Area under the plasma concentration-time curve during a dosing interval at steady state (AUCss)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) at steady state of RXC007 in plasma for all cohorts.
Measured: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
% predicted and absolute volume change from baseline in Forced Vital Capacity (FVC) at 12 weeks [central review]
Information on Forced Vital Capacity (FVC) for the 6 months prior to study entry will be collected. Spirometry testing (without bronchodilator use) will be performed at all scheduled study visits in clinic. For each patient, spirometry testing should be conducted at approximately the same time of day.
Measured: At Screening (Day28 to Day-1), Cycle1 Day1 pre-dose and post-dose, Cycle1 Day8, Cycle1 Day15, Cycle1 Day22, Cycle2 Day1(The day after Cycle1 Day28), Cycle2 Day15, Cycle3 Day1, Cycle3 Day28, End Of Treatment: last day of the dosing Day 21
% predicted and absolute change from baseline in carbon monoxide diffusion capacity (DLCO)
Carbon monoxide diffusion capacity will be measured in clinic
Measured: At Screening (day28 to Day-1), Cycle1 Day1 pre-dose, Cycle1 Day15, Cycle2 Day1 (The day after Cycle1 Day28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start8 Sep 2022
- Primary completion25 Jun 2024
- Study completion9 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Redx Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Responsible party
- Sponsor
- Investigators
- Philip Molyneaux, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustToby Maher, MD, Principal investigator, University of Southern California, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570058
- Sponsor's protocol ID
- RXC007/0002
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05570058
- Acronym / sponsor ID
- RXC007/0002
- Keywords
- Lung, Respiratory, Fibrosis, IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Redx Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 9 Jan 2025 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RXC007, Drug: Placebo12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing |
| Cohort 2 | Experimental | Drug: RXC007, Drug: Placebo12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing |
| Expansion Cohort | Experimental | Drug: RXC007, Drug: Placebo12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥40 to 80 years at the time of signing the informed consent.
- 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%.
Key exclusion criteria (11 listed)
- Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXC007RXC007 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 | Cohort 1, Cohort 2, Expansion Cohort |
| PlaceboThe 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 | Drug | Cohort 1, Cohort 2, Expansion Cohort |
Primary outcome
Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs
Time frame: From Day 1 to post-study follow up visit (12 weeks)
The primary endpoints of the study include the incidence and severity of AEs and SAEs
Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.
Time frame: From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to 12 weeks of treatment
Time frame: From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the vital signs parameters (systolic/diastolic blood pressure, pulse rate, respiration rate, oral body temperature) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) from first dose on Day 1 up to completion of the post-study visit.
Time frame: From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) as defined in the study protocol following first dose administration on Day 1 up to 12 weeks of treatment
11 secondary outcomes
Pharmacokinetic Parameters - Maximum plasma concentration (Cmax)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Minimum observed plasma concentration (Cmin)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Time to maximum observed concentration (Tmax)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Terminal elimination half-life (t1/2)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Elimination rate constant (λz)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Total apparent clearance following extravascular administration (CL/F)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Apparent volume of distribution following extravascular administration (Vz/F)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Area under the plasma concentration-time curve during a dosing interval at steady state (AUCss)
Time frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
% predicted and absolute volume change from baseline in Forced Vital Capacity (FVC) at 12 weeks [central review]
Time frame: At Screening (Day28 to Day-1), Cycle1 Day1 pre-dose and post-dose, Cycle1 Day8, Cycle1 Day15, Cycle1 Day22, Cycle2 Day1(The day after Cycle1 Day28), Cycle2 Day15, Cycle3 Day1, Cycle3 Day28, End Of Treatment: last day of the dosing Day 21
% predicted and absolute change from baseline in carbon monoxide diffusion capacity (DLCO)
Time frame: At Screening (day28 to Day-1), Cycle1 Day1 pre-dose, Cycle1 Day15, Cycle2 Day1 (The day after Cycle1 Day28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No. At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Molyneaux, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
Toby Maher, MD principal investigator
University of Southern California, USA
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RXC007 in people with IPF and Fibrosis, run by Redx Pharma Ltd at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy, United Kingdom, Spain, Poland, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs (time frame: From Day 1 to post-study follow up visit (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.