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Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years - 80 Years
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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 Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Redx Pharma Plc
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Philip Molyneaux, MDToby Maher, MD
Principal Investigator Affiliation
Royal Brompton & Harefield NHS Foundation TrustUniversity of Southern California, USA
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Austria, Belgium, Czechia, Italy, Poland, Spain, Switzerland, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
IPF, Fibrosis
Additional Details
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.
RXC007 will be administered in the form of oral capsules at 3 dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and 3 will receive RXC007 and 6 patients of cohorts 1B and 3B. 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 3. In Cohorts 1B and 3B, the placebo will be received by 2 of the 8 patients. The Dosage regimen is BID or QD
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Los Angeles, California
Status
Not yet recruiting
Address
University of Southern California - Center for Advanced Lung Disease
