First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma

NCT03287310 | Completed Phase 1 Results

• 2 other identifiers: 2057222016-004256-30
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating population of eosinophils. This is a single ascending dose FTIH study to investigate safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3511294, administered SC in subjects with mild to moderate asthma maintained on a low-medium daily dose of inhaled corticosteroids (ICS) or ICS/long acting beta-agonist (LABA), and short acting beta-agonist (SABA). The subjects will attend a pre-screen visit of up to 12 weeks before dosing for assessment of blood eosinophils. Eligible subjects with blood eosinophils \>=200 cells per microliter (cells/µL) will undergo a screening period of up to 4 weeks. The subjects will then be randomized into 5 cohorts. In each cohort, the subjects will be randomized to receive a single dose of GSK3511294 or placebo in a ratio of 3:1. The follow-up period will be up to 40 weeks post dose and will be dose-dependent. The scheduled maximum duration for each subject will be up to 44 weeks including up to 28 days of screening.

Conditions

Asthma

Keywords

eosinophils; pharmacokinetics; First time in Human; GSK3511294; pharmacodynamics; asthma

Outcome Measures

Primary Outcomes (23)

• Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.

  Up to Week 40

• Number of Participants With Adverse Events of Special Interest (AESI)

  AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.

  Up to Week 40

• Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count

  Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Red Blood Cell Count (RBC)

  Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Mean Corpuscle Volume (MCV)

  Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Mean Corpuscle Hemoglobin (MCH)

  Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Hemoglobin

  Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Hematocrit

  Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)

  Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin

  Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine

  Blood samples were collected at indicated time-points for analysis of clinical parameters like total bilirubin, direct bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Urine Specific Gravity Analysis by Dipstick Method

  Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

  SBP and DBP were assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Temperature

  Temperature was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Heart Rate

  Heart rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Respiration Rate

  Respiration rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Heart Rate: Electrocardiogram (ECG)

  12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval

  12-lead ECG were performed in a supine position using an automated ECG machine that calculated PR interval, QRS interval, QT interval and QTcF interval. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)

  Blood samples were collected at indicated time-points for analysis of clinical parameters like ALP, AST and ALT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium

  Blood samples were collected at indicated time-points for analysis of clinical parameters like glucose, calcium, potassium, sodium, BUN, and magnesium. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein

  Urine samples were collected to analyze presence of ketones, occult blood, glucose, and protein in urine. In this dipstick test, the level of occult blood, glucose, ketones and urine protein in urine samples were recorded as negative, trace, 1+ and 2+ indicating proportional concentrations in urine. Only categories with abnormal significant values have been presented.

  Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Urine Potential of Hydrogen (pH) Analysis by Dipstick Method

  Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

  Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

• Absolute Values of Complement (C)3 and C4

  Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.

  Baseline and at Days 2, 3, 4 and 5; Weeks 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Secondary Outcomes (36)

• Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg

  Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

• AUC(0-inf) of GSK3511294 30 mg and 100 mg

  Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

• AUC(0-inf) of GSK3511294 300 mg

  Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

• Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg

  Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

• AUC(0-t) of GSK3511294 30 mg and 100 mg

  Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

Study Arms (10)

Subjects receiving GSK3511294 in Cohort 1

EXPERIMENTAL

Six subjects in Cohort 1 will receive a single SC dose of 2 mg GSK3511294.

Drug: GSK3511294; Drug: Salbutamol/albuterol

Subjects receiving placebo in Cohort 1

PLACEBO COMPARATOR

Two subjects in Cohort 1 will receive a single SC dose of placebo.

Drug: Placebo; Drug: Salbutamol/albuterol

Subjects receiving GSK3511294 in Cohort 2

EXPERIMENTAL

Six subjects in Cohort 2 will receive a single SC dose of 10 mg GSK3511294.

Drug: GSK3511294; Drug: Salbutamol/albuterol

Subjects receiving placebo in Cohort 2

PLACEBO COMPARATOR

Two subjects in Cohort 2 will receive a single SC dose of placebo.

Drug: Placebo; Drug: Salbutamol/albuterol

Subjects receiving GSK3511294 in Cohort 3

EXPERIMENTAL

Nine subjects in Cohort 3 will receive a single SC dose of 30 mg GSK3511294.

Drug: GSK3511294; Drug: Salbutamol/albuterol

Subjects receiving placebo in Cohort 3

PLACEBO COMPARATOR

Three subjects in Cohort 3 will receive a single SC dose of placebo.

Drug: Placebo; Drug: Salbutamol/albuterol

Subjects receiving GSK3511294 in Cohort 4

EXPERIMENTAL

Nine subjects in Cohort 4 will receive a single SC dose of 100 mg GSK3511294.

Drug: GSK3511294; Drug: Salbutamol/albuterol

Subjects receiving placebo in Cohort 4

PLACEBO COMPARATOR

Three subjects in Cohort 4 will receive a single SC dose of placebo.

Drug: Placebo; Drug: Salbutamol/albuterol

Subjects receiving GSK3511294 in Cohort 5

EXPERIMENTAL

Six subjects in Cohort 5 will receive a single SC dose of 300 mg GSK3511294.

Drug: GSK3511294; Drug: Salbutamol/albuterol

Subjects receiving placebo in Cohort 5

PLACEBO COMPARATOR

Two subjects in Cohort 5 will receive a single SC dose of placebo.

Drug: Placebo; Drug: Salbutamol/albuterol

Interventions

GSK3511294 DRUG

GSK3511294 will be available as a clear or opalescent, colorless or yellow to brown solution for injection at unit dose strength of 150 milligrams per milliliter (mg/mL). GSK3511294 will be diluted in 0.9% weight by volume (w/v) sodium chloride to achieve the desired concentration for administration. GSK3511294 will be administered by SC injection.

Subjects receiving GSK3511294 in Cohort 1; Subjects receiving GSK3511294 in Cohort 2; Subjects receiving GSK3511294 in Cohort 3; Subjects receiving GSK3511294 in Cohort 4; Subjects receiving GSK3511294 in Cohort 5

Placebo DRUG

Matching Placebo will consist of 0.9% w/v sodium chloride which will be administered by the SC route.

Subjects receiving placebo in Cohort 1; Subjects receiving placebo in Cohort 2; Subjects receiving placebo in Cohort 3; Subjects receiving placebo in Cohort 4; Subjects receiving placebo in Cohort 5

Salbutamol/albuterol DRUG

Salbutamol/albuterol will be supplied to all subjects for use as rescue medication during the study.

Subjects receiving GSK3511294 in Cohort 1; Subjects receiving GSK3511294 in Cohort 2; Subjects receiving GSK3511294 in Cohort 3; Subjects receiving GSK3511294 in Cohort 4; Subjects receiving GSK3511294 in Cohort 5; Subjects receiving placebo in Cohort 1; Subjects receiving placebo in Cohort 2; Subjects receiving placebo in Cohort 3; Subjects receiving placebo in Cohort 4; Subjects receiving placebo in Cohort 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects should be between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• Blood eosinophils of \>= 200 cells/µL at screening.
• A physician diagnosis of asthma (mild or moderate, as defined by the Global Initiative for Asthma \[GINA\], 2017) at least 12 months prior to the start of the study. The reason for diagnosis of asthma should be documented in the subject's source data, including relevant history and investigations - specifically evidence of airway hyper-responsiveness, airflow variation (peak flow rate or forced expiratory volume in one second \[FEV1\]) or reversible airflow obstruction should also be documented in the subject's source data.
• A screening pre-bronchodilator FEV1 \>= 60% of predicted normal value.
• Asthma Control Test score \> 19.
• hsCRP of \< 10 milligrams per liter (mg/L) at screening.
• Otherwise healthy (other than the acceptable conditions of asthma and other atopic diseases, including allergic rhinitis and atopic dermatitis) based on a screening medical history, physical examination, vital signs, ECG assessment, pulmonary function testing, and clinical laboratory results.
• Maintained controlled on as needed SABA and one of the following: a) stable dose of ICS; b) stable dose of combination therapy: ICS/LABA.
• Body weight \>= 50 kilograms (kg), and body mass index (BMI) of 19-32 kilograms per square meter (kg/m\^2) inclusive.
• Male and female subjects. a) a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential. b) as GSK3511294 is a monoclonal antibody that is not anticipated to interact directly with Deoxyribonucleic acid (DNA) or other chromosomal material with minimal exposure through semen expected, male subjects will not be required to use contraception during the study, nor are they prohibited from donating sperm.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.

You may not qualify if:

• Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of screening, or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
• A history of life-threatening asthma defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
• Significant pulmonary diseases, other than asthma, including (but not limited to): pneumonia previously requiring hospital admission, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other significant respiratory abnormalities.
• Suspected or confirmed bacterial or viral infection (including tuberculosis) of the upper or lower respiratory tract, sinus or middle ear that occurred within and/or has not resolved within 4 weeks of screening that: led to a change in asthma management or in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
• Positive for hepatitis B surface antigen (HBsAg) at screening.
• Positive hepatitis C antibody test result at screening, or within 3 months prior to first dose of study treatment.
• Known immunodeficiency (other than that explained by the use of corticosteroids), including a positive test for human immunodeficiency virus (HIV) antibody at screening.
• Latent or chronic infections (example, genital herpes, urinary tract infections) or at risk of infection (example, significant trauma or infection within the 90 days before screening).
• Opportunistic infection within 6 months prior to screening (example, a non-tuberculous mycobacterial infection or cytomegalovirus, pneumocystosis, aspergillosis).
• Parasitic infestation within 6 months prior to screening, or have travelled to a country with a high prevalence of such infections in the 6 months before screening, or intend to do so in the year after dosing.
• Live vaccine within 4 weeks prior to screening, or intention to receive live vaccine during the study.
• Corrected QT by Fridericia's formula (QTcF) interval \> 450 milliseconds (msec)
• A personal history of severe hypertension, arrhythmia, Right Bundle Branch Block, or Left Bundle Branch Block, or a family history of sudden unexplained death, long QT, familial cardiac syndrome, or cardiomyopathy.
• ALT \>1.5 times upper limit of normal (ULN).
• Bilirubin \>1.5 times ULN. Isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Berlin, 14050, Germany

Location

GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

GSK Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

Related Publications (1)

• Singh D, Fuhr R, Bird NP, Mole S, Hardes K, Man YL, Cahn A, Yancey SW, Pouliquen IJ. A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. Br J Clin Pharmacol. 2022 Feb;88(2):702-712. doi: 10.1111/bcp.15002. Epub 2021 Aug 24.

  PMID: 34292606 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

8664357343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, double-blind study in which subjects will be allocated to five cohorts. The subjects in each cohort will be randomized to receive GSK3511294 and placebo in a ratio of 3:1. In each cohort, dosing will be staggered: one subject will receive GSK3511294 and one subject will receive placebo at least 72 hours before the remaining subjects in that cohort are dosed. The remaining subjects will be dosed if the review of all safety data up to 72 hours after dosing of the first two subjects in each cohort is satisfactory.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: October 17, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (3); DE (2)