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Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533022
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : March 3, 2022
Sponsor:
Collaborator:
Orphan Reach
Information provided by (Responsible Party):
Vicore Pharma AB

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
Idiopathic Pulmonary Fibrosis Drug: C21 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 13, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: C21 Drug: C21
C21 b.i.d.




Primary Outcome Measures :
  1. Nature and frequency of adverse events occurring over the trial period [ Time Frame: Trial period of 36 weeks ]
    Primary endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    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

  8. 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
  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:
    • 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
  8. 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)
  9. 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)
  10. Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline, 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
  13. Female 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533022


Contacts
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Contact: Mikkel Walmar, MSc +45 41904422 mikkel.walmar@vicorepharma.com
Contact: Rohit Batta, MD +44 (0) 7950670515 rohit.batta@vicorepharma.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Vicore Pharma AB
Orphan Reach
Investigators
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Principal Investigator: Joanna Porter, MD Respiratory Medicine, University College Hospital
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Responsible Party: Vicore Pharma AB
ClinicalTrials.gov Identifier: NCT04533022    
Other Study ID Numbers: VP-C21-005
2020-000822-24 ( EudraCT Number )
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022

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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:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases