A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects With Idiopathic Pulmonary Fibrosis

Vicore Pharma AB21 sites in 4 countries52 target enrollmentNovember 13, 2020

ConditionsIdiopathic Pulmonary Fibrosis

InterventionsC21

DrugsC21

Overview

Phase: Phase 2
Intervention: C21
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Vicore Pharma AB
Enrollment: 52
Locations: 21
Primary Endpoint: Number of Participants With Adverse Events Occurring Over the Trial Period
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 13, 2020

End Date

March 30, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vicore Pharma AB

Responsible Party

Sponsor

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 \<18
•IPF exacerbation within 3 months prior to Visit 1:
•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
•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
•Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
•Treatment with any of the medications listed below within 4 weeks prior to Visit 1:

Arms & Interventions

C21

C21 100 mg BID (twice daily)

Intervention: C21

Outcomes

Primary Outcomes

Number of Participants With Adverse Events Occurring Over the Trial Period

Time Frame: Trial period of 36 weeks

Number of participants with adverse events occurring over the trial period incl. number of participants with any TEAE, serious TEAEs, TEAEs leading to withdrawal from trial, TEAEs leading to discontinuation of treatment, treatment-related TEAEs leading to discontinuation of treatment, TEAEs leading to death, and serious treatment-related TEAEs. Adverse events were recorded from signing of informed consent until end of trial. Nature and frequency of adverse events are presented in details in the adverse events section.

Secondary Outcomes

AUClast in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
Accumulation Ratio AUC in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
Tmax in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
Change From Baseline in Forced Vital Capacity (Non-imputed Data)(12, 24, and 36 weeks)
Change From Baseline in Forced Vital Capacity (Imputed Data)(12, 24, and 36 weeks)
Rate of Forced Vital Capacity Decline Over Time, FAS(12, 24, and 36 weeks)
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose on Day 1)
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 12)
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 24)
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 36)
Cmax in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)