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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000822-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Orphan Reach Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C21 | Experimental | C21 100 mg BID (twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C21 | Drug | C21 100 mg BID (twice daily) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Trial period of 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12, 24, and 36 weeks |
| Change From Baseline in Forced Vital Capacity (Imputed Data) |
Not provided
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:
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:
Treatment with any of the medications listed below within 2 weeks prior to Visit 1:
Any of the following findings at Visit 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
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
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Porter, MD | Respiratory Medicine, University College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCMET Medical College and Sheth LG General Hospital | Ahmedabad | Gujarat | 380008 | India | ||
| Unity Hospital |
52 participants were enrolled and received at least one dose of C21. 138 participants signed informed content and were screened, however, 86 of those were screening failures and thus not enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | C21 100 mg BID | Oral administration of 100 mg BID C21 (200 mg daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2021 |
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Mean changes in forced vital capacity (FVC) (mL) from baseline to week 12, week 24, and week 36 were calculated |
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 |
| Surat |
| Gujarat |
| 395010 |
| India |
| The Bhatia Hospital | Mumbai | Maharashtra | 400007 | India |
| Grant Government Medical Collage and Sir J.J. Group of Hospitals | Mumbai | Maharashtra | 400008 | India |
| N. K. P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital | Nagpur | Maharashtra | 440019 | India |
| Ace Hospital & Research Center | Pune | Maharashtra | 411004 | India |
| Oyster & Pearl Hospitals | Pune | Maharashtra | 411005 | India |
| Hindusthan Hospital | Coimbatore | Tamil Nadu | 641028 | India |
| Jawaharlal Nehru Medical College - Aligarh Muslim University | Aligarh | Uttar Pradesh | 202002 | India |
| Midland Healthcare and Research Centre | Lucknow | Uttar Pradesh | India |
| Apollo Spectra Hospitals (Apollo Speciality Hospital Pvt. Ltd.) | Kanpur | 208001 | India |
| Clinical Hospital for Emergency Medical Care n.a. N.V. Solovyev | Yaroslavl | Russia |
| MNCE City Clinical Hospital | Kharkiv | 61124 | Ukraine |
| Lviv National Medical University | Lviv | 79010 | Ukraine |
| Odessa Regional Hospital | Odesa | 65025 | Ukraine |
| Private Small Scale Enterprise Medical Center 'PULSE' | Vinnytsia | 21001 | Ukraine |
| University Hospital Birmingham | Birmingham | B15 2TH | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| University College Hospital | London | United Kingdom |
| University College London Hospitals | London | United Kingdom |
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C21 100 mg BID, SAS | Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||||||||
| Smoking status | Count of Participants | Participants |
| |||||||||||||||||||||||
| E-cigarettes and vapes status | Count of Participants | Participants |
| |||||||||||||||||||||||
| Time since diagnosis of idiopathic pulmonary fibrosis | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Oxygen saturation at screening | Mean | Standard Deviation | Percentage of oxygen saturation |
| ||||||||||||||||||||||
| FEV1 | Forced expiratory volume in the first sec | Mean | Standard Deviation | L |
| |||||||||||||||||||||
| FVC | Forced vital capacity | Mean | Standard Deviation | L |
| |||||||||||||||||||||
| FEV1/FVC | Mean | Standard Deviation | ratio |
| ||||||||||||||||||||||
| FEV1 (% predicted normal) | Mean | Standard Deviation | Percentage of predicted normal FEV1 |
| ||||||||||||||||||||||
| FVC (% predicted normal) | Mean | Standard Deviation | Percentage of predicted normal FVC |
| ||||||||||||||||||||||
| Age of High-resolution computed tomography (HRCT) scan | Mean | Standard Deviation | Months |
| ||||||||||||||||||||||
| Previous use of antifibrotics | Count of Participants | Participants |
| |||||||||||||||||||||||
| HRCT pattern (central reading) | A high-resolution computed tomography (HRCT) within 36 months prior to Visit 1 was obtained and the pattern categorized. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety analysis set | Posted | Count of Participants | Participants | Trial period of 36 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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 | Participants in the Full analysis set (FAS) with a measurement. | Posted | Mean | 90% Confidence Interval | mL | 12, 24, and 36 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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 | Full analysis set with imputed data | Posted | Mean | 90% Confidence Interval | mL | 12, 24, and 36 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set | Posted | Mean | 90% Confidence Interval | mL | 12, 24, and 36 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | Full Range | h | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 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 |
|
|
Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C21 100 mg BID | Oral administration of 100 mg BID C21 (200 mg daily) | 2 | 52 | 5 | 52 | 35 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief medical officer Bertil Lindmark | Vicore Pharma AB | +46 707661505 | info@vicorepharma.com |
| Mar 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711730 | compound 21 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| India |
|
| Russia |
|
| Never |
|
| Missing |
|
| Never |
|
| Missing |
|
| HRCT Feature most consistent with Non-IPF diagnosis |
|
| Missing |
|
|
| Total number of subjects with TEAEs leading to discontinuation of treatment |
|
| Total number of subjects with treatment-related TEAEs leading to discontinuation of treatment |
|
| Total number of subjects with TEAEs leading to death |
|
| Total number of subjects with serious treatment-related TEAEs |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 12 |
| |||||
| Week 24 |
| |||||
| Week 36 |
|
| Title | Denominators | Categories |
|---|
| Week 12 |
| |||||
| Week 24 |
| |||||
| Week 36 |
|
|
| Title | Denominators | Categories |
|---|
| Prior to dosing |
| |||||
| 30 min post dose |
| |||||
| 1 h post dose |
| |||||
| 2 h post dose |
| |||||
| 3 h post dose |
| |||||
| 4 h post dose |
|
| Title | Denominators | Categories |
|---|
| Prior to dosing |
| |||||
| 30 min post dose |
| |||||
| 1 h post dose |
| |||||
| 2 h post dose |
| |||||
| 3 h post dose |
| |||||
| 4 h post dose |
|
| Title | Denominators | Categories |
|---|
| Prior to dosing |
| |||||
| 30 min post dose |
| |||||
| 1 h post dose |
| |||||
| 2 h post dose |
| |||||
| 3 h post dose |
| |||||
| 4 h post dose |
|
| Title | Denominators | Categories |
|---|
| Prior to dosing |
| |||||
| 30 min post dose |
| |||||
| 1 h post dose |
| |||||
| 2 h post dose |
| |||||
| 3 h post dose |
| |||||
| 4 h post dose |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 0 Weeks |
| |||||
| 12 Weeks |
| |||||
| 24 Weeks |
| |||||
| 36 Weeks |
|
| Title | Denominators | Categories |
|---|
| Week 0 |
| |||||
| Week 12 |
| |||||
| Week 24 |
| |||||
| Week 36 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 0 |
| |||||
| Week 12 |
| |||||
| Week 24 |
| |||||
| Week 36 |
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| Title | Denominators | Categories |
|---|
| Week 12 |
| |||||
| Week 24 |
| |||||
| Week 36 |
|