To investigate the safety, effectiveness and fate of study drug C21 in people with chronic scarring lung disease characterised by a progressive and irreversible decline in lung function.
- Conditions
- Idiopathic Pulmonary FibrosisMedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-000822-24-GB
- Lead Sponsor
- Vicore Pharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1) Written informed consent obtained before the initiation of any trial related procedure
2) A diagnosis of IPF within 3 years prior to Visit 1
3) Age =40 years
4) FVC =80% predicted at Visit 1
5) FEV1/FVC ratio >0.7 prebronchodilator at Visit 1
6) Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1
7) Diffuse capacity for carbon monoxide (DLCO) >30% of predicted normal corrected for haemoglobin at Visit 1
8) High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating:
a. A pattern consistent with usual interstitial pneumonitis (UIP)
b. Extent of fibrosis > extent of emphysema
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1)Previous and concomitant use of nintedanib or pirfenidone
2)Smoking (including e-cigarettes) within 6 months prior to Visit 1
3)Body mass index (BMI) >35 or <18
4)IPF exacerbation within 3 months prior to Visit 1, as defined by Collard et al. (2016):
•Acute worsening or development of dyspnoea typically <1 month duration
•Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier new” can be dropped)
•Deterioration not fully explained by cardiac failure or fluid overload
5)Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery) which in the opinion of the investigator makes the subject inappropriate for this trial
6)Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
7)Treatment with any of the medications listed below within 4 weeks prior to Visit 1:
•Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John’s Wort)
•CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
•Medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
•Experimental drugs
•Any systemic immunosuppressive therapies other than:
oInhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable
oCorticosteroids for the treatment of acute exacerbations
oThe continuation of stable doses of <15 mg daily doses of prednisolone
8)Treatment with any of the medications listed below within 2 weeks prior to Visit 1:
oProton pump inhibitors (PPI’s) more than once daily
oHistamine H2 receptor antagonists (H2RA’s)
oBreast cancer resistance protein sensitive substrates (e.g. sulphasalazine, rosuvastatin)
9)Any of the following findings at Visit 1:
oProlonged QTcF (QT interval with Fridericia’s correction) (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
oPositive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab
oPositive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])
10)Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline (Miller et al. 2005), as determined by central review
11)Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator
12)Pregnant or breast-feeding female subjects
13Female subjects of childbearing potential not willing to use contraceptive methods
14)Male subjects not willing to use contraceptive methods
15)Subjects not willing to adhere to dietary restrictions during the trial period
16)Participation in any other interventional trial during the trial period
17)Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the safety of C21 with 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF. ;Secondary Objective: To evaluate:<br>•The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 24 weeks<br>•The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 36 weeks<br>•The pharmacokinetic (PK) profile of C21 200 mg daily dose (100 mg b.i.d.) after multiple dosing<br><br>;Primary end point(s): Nature and frequency of adverse events .;Timepoint(s) of evaluation of this end point: Occuring over the trial period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): a)Change from baseline in forced vital capacity (FVC) value <br>b)Plasma concentration of C21 and derived PK parameters evaluated in a sub-set of subjects<br>;Timepoint(s) of evaluation of this end point: for a) occurring over 12, 24, and 36 weeks<br>