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Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04533022
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vicore Pharma AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joanna Porter, MD
Principal Investigator Affiliation Respiratory Medicine, University College Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries India, Russian Federation, Ukraine, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: C21

Interventions

Drug: - C21

C21 b.i.d.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ahmedabad, Gujarat, India

Status

Recruiting

Address

AMCMET Medical College and Sheth LG General Hospital

Ahmedabad, Gujarat, 380008

Unity Hospital, Surat, Gujarat, India

Status

Recruiting

Address

Unity Hospital

Surat, Gujarat, 395010

The Bhatia Hospital, Mumbai, Maharashtra, India

Status

Recruiting

Address

The Bhatia Hospital

Mumbai, Maharashtra, 400007

Mumbai, Maharashtra, India

Status

Recruiting

Address

Grant Government Medical Collage and Sir J.J. Group of Hospitals

Mumbai, Maharashtra, 400008

Nagpur, Maharashtra, India

Status

Recruiting

Address

N. K. P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital

Nagpur, Maharashtra, 440019

Ace Hospital & Research Center, Pune, Maharashtra, India

Status

Recruiting

Address

Ace Hospital & Research Center

Pune, Maharashtra, 411004

Oyster & Pearl Hospitals, Pune, Maharashtra, India

Status

Recruiting

Address

Oyster & Pearl Hospitals

Pune, Maharashtra, 411005

Hindusthan Hospital, Coimbatore, Tamilnadu, India

Status

Recruiting

Address

Hindusthan Hospital

Coimbatore, Tamilnadu, 641028

Site Contact

Srikanth Krishnamurthy

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560

Alīgarh, Uttar Pradesh, India

Status

Recruiting

Address

Jawaharlal Nehru Medical College - Aligarh Muslim University

Alīgarh, Uttar Pradesh, 202002

Midland Healthcare and Research Centre, Lucknow, Uttar Pradesh, India

Status

Recruiting

Address

Midland Healthcare and Research Centre

Lucknow, Uttar Pradesh,

Kanpur, India

Status

Recruiting

Address

Apollo Spectra Hospitals (Apollo Speciality Hospital Pvt. Ltd.)

Kanpur, , 208001

Site Contact

Sandeep Katiyar, Dr.

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560

Kazan State Medical University, Kazan, Russian Federation

Status

Withdrawn

Address

Kazan State Medical University

Kazan, ,

Moscow State Medical University, Moscow, Russian Federation

Status

Withdrawn

Address

Moscow State Medical University

Moscow, ,

St Petersburg, Russian Federation

Status

Withdrawn

Address

St Petersburg Pavlov State Medical University

St Petersburg, ,

Yaroslavl, Russian Federation

Status

Active, not recruiting

Address

Clinical Hospital for Emergency Medical Care n.a. N.V. Solovyev

Yaroslavl, ,

MNCE City Clinical Hospital, Kharkiv, Ukraine

Status

Active, not recruiting

Address

MNCE City Clinical Hospital

Kharkiv, , 61124

Lviv National Medical University, Lviv, Ukraine

Status

Active, not recruiting

Address

Lviv National Medical University

Lviv, , 79010

Odessa Regional Hospital, Odessa, Ukraine

Status

Active, not recruiting

Address

Odessa Regional Hospital

Odessa, , 65025

Vinnytsia, Ukraine

Status

Active, not recruiting

Address

Private Small Scale Enterprise Medical Center 'PULSE'

Vinnytsia, , 21001

University Hospital Birmingham, Birmingham, United Kingdom

Status

Recruiting

Address

University Hospital Birmingham

Birmingham, , B15 2TH

Site Contact

Anjali Crawshaw, MD

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560

Royal Brompton Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Brompton Hospital

London, , SW3 6NP

Site Contact

Phillip Molyneux, MD

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560

University College Hospital, London, United Kingdom

Status

Recruiting

Address

University College Hospital

London, ,

Site Contact

Joanne Porter, Prof.

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560

University College London Hospitals, London, United Kingdom

Status

Recruiting

Address

University College London Hospitals

London, ,

Site Contact

Joanne Porter, MD

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560

Medicines Evaluation Unit, Manchester, United Kingdom

Status

Recruiting

Address

Medicines Evaluation Unit

Manchester, , M23 9QZ

Site Contact

Pilar Rivera-Ortega, MD

kamilla.overbeck@vicorepharma.com

+46 (0) 317880560