Phase 2
N=52
Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04533022 ↗Enrolled (actual)
52
Serious AEs
9.6%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Adverse Events Occurring Over the Trial Period — 37; 5; 6; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- C21 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Vicore Pharma AB
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Occurring Over the Trial Period |
37; 5; 6; 12; 3; 2 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Non-imputed Data) |
-4.9; 16.0; 216.0 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Imputed Data) |
-57.6; -70.3; 9.4 | — |
| SECONDARY Rate of Forced Vital Capacity Decline Over Time, FAS |
-8.2; 36.4; 108.9 | — |
| SECONDARY Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1 |
5.00; 1622.0; 1788.11; 864.46; 322.19; 282.82 | — |
| SECONDARY Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12 |
27.13; 974.28; 1044.02; 794.02; 491.25; 101.50 | — |
| SECONDARY Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24 |
20.14; 615.53; 898.61; 404.80; 151.30; 115.93 | — |
| SECONDARY Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36 |
89.78; 796.29; 713.86; 298.29; 374.16; 348.11 | — |
| SECONDARY Cmax in a Sub-set of Subjects |
1852.13; 954.29; 524.79; 961.86 | — |
| SECONDARY Tmax in a Sub-set of Subjects |
1.00; 1.50; 1.00; 1.00 | — |
| SECONDARY AUClast in a Sub-set of Subjects |
3018.151; 1704.924; 995.600; 1622.774 | — |
| SECONDARY Accumulation Ratio AUC in a Sub-set of Subjects |
0.84598; 0.45256; 0.73765 | — |
Summary
This trial is a multi-centre, open-label, single-arm phase 2 trial investigating the safety, efficacy and pharmacokinetics of C21 in subjects with idiopathic pulmonary fibrosis.
Eligibility Criteria
Inclusion Criteria
- Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
- A diagnosis of IPF within 5 years prior to Visit 1, as per either ATS/ERS/JRS/ATLAT/Fleischner guidelines
- Age ≥40 years
- Forced vital capacity (FVC) ≥60% predicted at Visit 1 (specifically for UK: FVC ≥80% predicted at Visit 1)
- Forced expiratory volume in the first sec (FEV1)/FVC ratio ≥0.7 prebronchodilator at Visit 1
- Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1
- High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating either a or b, and c:
a. A pattern consistent with usual interstitial pneumonitis (UIP) according to ATS/ERS/JRS/ALAT or Fleischner guidelines i. UIP ii. Probable UIP or b. A pattern indeterminate for UIP according to either ATS/ERS/JRS/ALAT or Fleischner guidelines and a historical biopsy consistent with IPF c. Extent of fibrosis > extent of emphysema
- Fully vaccinated against COVID-19 prior to screening (Visit 1). Subjects are considered fully vaccinated for COVID-19 ≥14 days after they have received vaccination dose(s) according to local label
Exclusion Criteria
- Previous use of antifibrotic treatment for an interstitial lung disease (e.g. nintedanib or pirfenidone) for > 6 months
- Smoking (including e-cigarettes) within 6 months prior to Visit 1
- Body mass index (BMI) >35 or 450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
- Positive 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)
- Positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin)
- Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline, as determined by central review
- 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
- Pregnant or breast-feeding female subjects
- Female subjects of childbearing potential not willing to use contraceptive methods
- Male subjects not willing to use contraceptive methods
- Subjects not willing to adhere to dietary restrictions during the trial period
- Participation in any other interventional trial during the trial period
- Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Discontinuation or change of previous antifibrotic treatment (e.g. nintedanib or pirfenidone) due to disease progression
Data sourced from ClinicalTrials.gov (NCT04533022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.