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Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF

Sponsor
Vicore Pharma AB (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04533022
Collaborator
Orphan Reach (Other)
60
Enrollment
23
Locations
1
Arm
24.6
Anticipated Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects With Idiopathic Pulmonary Fibrosis
Actual Study Start Date :
Nov 13, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: C21

Drug: C21
C21 b.i.d.

Outcome Measures

Primary Outcome Measures

  1. Nature and frequency of adverse events occurring over the trial period [Trial period of 36 weeks]

    Primary endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure

  2. A diagnosis of IPF within 3 years prior to Visit 1, as per either ATS/ERS/JRS/ATLAT/Fleischner guidelines

  3. Age ≥40 years

  4. FVC ≥60% predicted at Visit 1 (specifically for UK: 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. High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating either a or b, and c:

  1. 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
  1. 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:

  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:

  • 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

  1. 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

  2. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I

  3. 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:

  • Inhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable

  • Corticosteroids for the treatment of acute exacerbations

  • The continuation of stable doses of ≤15 mg daily doses of prednisolone

  1. Treatment with any of the medications listed below within 2 weeks prior to Visit 1:

  • Proton pump inhibitors (PPI's) more than once daily

  • Histamine H2 receptor antagonists (H2RA's)

  • Breast cancer resistance protein sensitive substrates (e.g. sulphasalazine, rosuvastatin)

  1. Any of the following findings at Visit 1:

  • Prolonged 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

  • 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)

  1. Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline, as determined by central review

  2. 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

  3. Pregnant or breast-feeding female subjects

  4. Female subjects of childbearing potential not willing to use contraceptive methods

  5. Male subjects not willing to use contraceptive methods

  6. Subjects not willing to adhere to dietary restrictions during the trial period

  7. Participation in any other interventional trial during the trial period

  8. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

Contacts and Locations

Locations

Site City State Country Postal Code
1 AMCMET Medical College and Sheth LG General Hospital Ahmedabad Gujarat India 380008
2 Unity Hospital Surat Gujarat India 395010
3 The Bhatia Hospital Mumbai Maharashtra India 400007
4 Grant Government Medical Collage and Sir J.J. Group of Hospitals Mumbai Maharashtra India 400008
5 N. K. P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital Nagpur Maharashtra India 440019
6 Ace Hospital & Research Center Pune Maharashtra India 411004
7 Oyster & Pearl Hospitals Pune Maharashtra India 411005
8 Hindusthan Hospital Coimbatore Tamilnadu India 641028
9 Jawaharlal Nehru Medical College - Aligarh Muslim University Alīgarh Uttar Pradesh India 202002
10 Midland Healthcare and Research Centre Lucknow Uttar Pradesh India
11 Kazan State Medical University Kazan Russian Federation
12 Moscow State Medical University Moscow Russian Federation
13 St Petersburg Pavlov State Medical University St Petersburg Russian Federation
14 Clinical Hospital for Emergency Medical Care n.a. N.V. Solovyev Yaroslavl Russian Federation
15 MNCE City Clinical Hospital Kharkiv Ukraine 61124
16 Lviv National Medical University Lviv Ukraine 79010
17 Odessa Regional Hospital Odessa Ukraine 65025
18 Private Small Scale Enterprise Medical Center 'PULSE' Vinnytsia Ukraine 21001
19 University Hospital Birmingham Birmingham United Kingdom B15 2TH
20 Royal Brompton Hospital London United Kingdom SW3 6NP
21 University College Hospital London United Kingdom
22 University College London Hospitals London United Kingdom
23 Medicines Evaluation Unit Manchester United Kingdom M23 9QZ

Sponsors and Collaborators

  • Vicore Pharma AB
  • Orphan Reach

Investigators

  • Principal Investigator: Joanna Porter, MD, Respiratory Medicine, University College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vicore Pharma AB
ClinicalTrials.gov Identifier:
NCT04533022
Other Study ID Numbers:
  • VP-C21-005
  • 2020-000822-24
First Posted:
Aug 31, 2020
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vicore Pharma AB
Idiopathic Pulmonary Fibrosis
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis

Study Results

No Results Posted as of Jun 16, 2022