Idiopathic Pulmonary FibrosisPhase 2NCT04533022
Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF
A Phase 2 study testing C21 in people with Idiopathic Pulmonary Fibrosis, run by Vicore Pharma AB at 21 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- C21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 13 Nov 2020to 30 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating either a or b, and c:
- 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
Who cannot join
- 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)
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- 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:
- 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
- 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)
- Sulphasalazine and rosuvastatin
- High dose breast cancer resistance protein sensitive substrates (other than sulphasalazine or rosuvastatin)
- 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)
- 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
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
India11 sites
AMCMET Medical College and Sheth LG General Hospital
Ahmedabad, Gujarat, 380008
Jawaharlal Nehru Medical College - Aligarh Muslim University
Aligarh, Uttar Pradesh, 202002
Hindusthan Hospital
Coimbatore, Tamil Nadu, 641028
Apollo Spectra Hospitals (Apollo Speciality Hospital Pvt. Ltd.)
Kanpur, 208001
Midland Healthcare and Research Centre
Lucknow, Uttar Pradesh
The Bhatia Hospital
Mumbai, Maharashtra, 400007
Grant Government Medical Collage and Sir J.J. Group of Hospitals
Mumbai, Maharashtra, 400008
N. K. P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
Nagpur, Maharashtra, 440019
Ace Hospital & Research Center
Pune, Maharashtra, 411004
Oyster & Pearl Hospitals
Pune, Maharashtra, 411005
Unity Hospital
Surat, Gujarat, 395010
United Kingdom5 sites
University Hospital Birmingham
Birmingham, B15 2TH
Royal Brompton Hospital
London, SW3 6NP
University College Hospital
London
University College London Hospitals
London
Medicines Evaluation Unit
Manchester, M23 9QZ
Ukraine4 sites
MNCE City Clinical Hospital
Kharkiv, 61124
Lviv National Medical University
Lviv, 79010
Odessa Regional Hospital
Odesa, 65025
Private Small Scale Enterprise Medical Center 'PULSE'
Vinnytsia, 21001
Russia1 site
Clinical Hospital for Emergency Medical Care n.a. N.V. Solovyev
Yaroslavl
About this study
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
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- C21
- Keywords
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C21Drug
Also called Buloxibutid, Compound 21
C21 100 mg BID (twice daily)
| Study group | Role | What they receive |
|---|---|---|
| C21 | Experimental | C21 100 mg BID (twice daily) Receives: Drug: C21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events Occurring Over the Trial Period
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.
Measured: Trial period of 36 weeks
Secondary outcomes (11)
Change From Baseline in Forced Vital Capacity (Non-imputed Data)
Mean changes in forced vital capacity (FVC) (mL) from baseline to week 12, week 24, and week 36 were calculated
Measured: 12, 24, and 36 weeks
Change From Baseline in Forced Vital Capacity (Imputed Data)
Mean changes in forced vital capacity (FVC) (mL) from baseline to week 12, week 24, and week 36 were calculated
Measured: 12, 24, and 36 weeks
Rate of Forced Vital Capacity Decline Over Time, FAS
Model-based mean (90% CI) FVC changes over 12, 24, and 36 weeks were normalized to change over 24 weeks.
A piece-wise linear regression model with knots at weeks 6 and 24 and unstructured covariance matrix was fitted to change from baseline data. Knot selection was performed by visual inspection.
The model based change over 12, 24, and 36 weeks was normalized to represent a change over 24 weeks.
Rate of decline was computed as y(t) - y(0) = t*Beta1 + max(0, t-6)*Beta2 + max(0,t-24)*Beta3, adjusted to show the decline per 24 weeks, where y is the value at the respective week and Beta is the model coefficient.
No imputation of data was conducted.
Measured: 12, 24, and 36 weeks
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
The plasma concentration of C21 (ng/mL) was calculated in a subset of subjects at specified timepoints post-dose.
Measured: 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
The plasma concentration of C21 (ng/mL) was calculated at specified timepoints post-dose after 12 weeks of dosing.
Measured: 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
The plasma concentration of C21 (ng/mL) was calculated at specified timepoints post-dose after 24 weeks of dosing.
Measured: 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
The plasma concentration of C21 (ng/mL) was calculated at specified timepoints post-dose after 36 weeks of dosing.
Measured: 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
The maximal plasma concentration (Cmax (ng/ml)) was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Measured: 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
The time for the maximal plasma concentration (Tmax (h)) was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Measured: 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
AUClast in a Sub-set of Subjects
Area under the plasma concentration time curve to the last quantified concentration (AUClast) (h*ng/mL) was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Measured: 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
Accumulation ratio AUC was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start13 Nov 2020
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orphan Reach Ltd.
- Responsible party
- Sponsor
- Investigators
- Joanna Porter, MD, Principal investigator, Respiratory Medicine, University College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533022
- Sponsor's protocol ID
- VP-C21-005
- Other IDs
- 2020-000822-24
- Status last verified
- May 2025
- First submitted
- 26 Aug 2020
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04533022
- Acronym / sponsor ID
- VP-C21-005
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Orphan Reach Ltd.
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C21 | Experimental | Drug: C21C21 100 mg BID (twice daily) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (36 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C21Also: Buloxibutid, Compound 21C21 100 mg BID (twice daily) | Drug | C21 |
Primary outcome
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.
11 secondary outcomes
Change From Baseline in Forced Vital Capacity (Non-imputed Data)
Time frame: 12, 24, and 36 weeks
Change From Baseline in Forced Vital Capacity (Imputed Data)
Time frame: 12, 24, and 36 weeks
Rate of Forced Vital Capacity Decline Over Time, FAS
Time frame: 12, 24, and 36 weeks
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
AUClast in a Sub-set of Subjects
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Porter, MD principal investigator
Respiratory Medicine, University College Hospital
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C21 in people with Idiopathic Pulmonary Fibrosis, run by Vicore Pharma AB at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in India, United Kingdom, Ukraine, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events Occurring Over the Trial Period (time frame: Trial period of 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.