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Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP) (COPD-ST2OP)

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: NCT03615040
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Biomedical Research Centre- Respiratory (Glenfield Hospital, Leicester UK)
Leicester Clinical Trials Unit
Genentech, Inc.
Information provided by (Responsible Party):
University of Leicester

Brief Summary:
This will be a single-centre, double-blinded, placebo- controlled, parallel group, randomised controlled trial comparing MSTT1041A (anti-ST2 antibody) versus placebo in COPD. MSTT1041A 490mg s/c or matched placebo dosed every 4 weeks for a total of 12 doses. Patients will be followed up for 60 weeks (i.e. 48 week treatment period and 12 week follow-up), with secondary outcome measures at baseline, 4, 12, 24, 36, 48 and 60 weeks and at exacerbation events presenting prior to treatment initiation.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Drug: MSTT1041A Drug: Placebo Phase 2

Detailed Description:

This is a single-centre, double-blind, placebo- controlled, parallel group, randomised controlled trial to assess the efficacy and safety of anti-ST2 compared to placebo, in patients with moderate to very severe COPD (GOLD II-IV). Anti-ST2 will be administered via subcutaneous injection once every 4 weeks (Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44) during the 48-week treatment period. The treatment period will be followed by a 12-week follow-up period.

After signing the informed consent at the initial visit, patients will enter a screening period which should last for up to 2 weeks unless extension of the screening period is necessary under certain circumstances. Patients who qualify to participate in the study will be randomized into a 48-week treatment period in which they will receive either 490 mg anti-ST2 or a matching placebo. Patients will be evaluated for an additional 12 weeks following completion of the randomized treatment period. An interim analysis is planned when the last patient completes the 48-week treatment period. Treatment groups will remain blinded until the 48-week follow-up period is completed, and trial database is locked.

This study will be a single-centre randomised controlled trial (RCT), sponsored by the University of Leicester and coordinated by the Leicester National Institute for Health Research (NIHR) Respiratory Biomedical Research Centre (BRC) and Leicester Clinical Trials Unit (LCTU).

The primary objective of the study is to evaluate the efficacy of anti-ST2 versus placebo on frequency of moderate-to-severe exacerbations (health care utilisation resulting in treatment with systemic corticosteroids and/or antibiotics or hospitalisation, respectively) as add-on to standard of care

Another key objective is to assess the safety and tolerability of subcutaneous (SC) doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD.

Additionally, to assess the effects of anti-ST2 versus placebo both during stable visits and at the exacerbation events on the following:

  1. Symptoms
  2. Health status
  3. Lung function
  4. Sputum airway inflammation
  5. Upper airway inflammation
  6. Systemic inflammation
  7. Airway infection and ecology
  8. Breath volatile organic compound profiling
  9. Airway morphometry and lung densitometry
  10. Pharmacogenomics
  11. Pharmacokinetics and ADA level

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-centre, double-blinded, placebo-controlled, parallel group, randomised controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A or B
Primary Purpose: Treatment
Official Title: A Randomised Placebo-controlled Trial of Anti-ST2 in COPD (COPD-ST2OP)
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Anti-ST2
Anti-ST2 (MSTT1041A) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.
Drug: MSTT1041A

MSTT1041A (RO7187807; formerly made by Amgen [AMG] and referred to as AMG 282) is a novel biopharmaceutical that blocks signaling of interleukin (IL)-33, an inflammatory cytokine of the IL-1 family and member of the newly discovered "alarmin" class of molecules. IL-33 is released from airway epithelial cells in response to allergens, irritants, and infection. IL-33 release can trigger acute exacerbations in both asthma and COPD. MSTT1041A has the ability to block inflammation,prevent exacerbations, and improve lung function and quality of life.

Anti-ST2 is presented as sterile, clear, and colourless to slightly yellow liquid. Each sterile vial is filled with a 1 mL deliverable volume of 70 mg/mL. It is formulated with 15 mM sodium acetate, 9.0% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 5.2.

Other Names:
  • RO7187807
  • ST2 MAb
  • Anti-ST2
  • AMG 282
  • RG6149

Placebo Comparator: Placebo
Placebo (no active component) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.
Drug: Placebo
Placebo for Anti-ST2 (MSTT1041A) is formulated with 10 mM sodium acetate, 9.0% (w/v) sucrose, 0.004% (w/v) polysorbate 20, pH 5.2, and is supplied in an identical vial configuration.




Primary Outcome Measures :
  1. Frequency of moderate to severe exacerbation (defined as requiring treatment with systemic corticosteroids and/or antibiotics in the community or hospital or hospitalisation). [ Time Frame: 0-48 weeks ]

    where a COPD exacerbation is defined by symptomatic worsening of COPD requiring:

    • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
    • Use of antibiotics and/or
    • inpatient hospitalisation or death due to COPD


Secondary Outcome Measures :
  1. St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60 ]

    To evaluate health status; designed to measure health impairment in patients with asthma and COPD. It is in two parts. Part I produces the Symptoms score, and Part 2 the Activity and Impacts scores. A Total score is also produced.

    2. The Total score is calculated by summing the weights to all the positive responses in each component. The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage. Maximum possible weights for components: Symptoms (566.2), Activity (982.9), Impacts (1652.8). Total (3201.9, which would represent the worst possible state of the patient.


  2. COPD Assessment Test (CAT) (Questionnaire) [ Time Frame: Weeks 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To evaluate health status: evaluation and rehabilitation education guidance on the respiratory and motor functions of patients with chronic obstructive pulmonary disease. The CAT has a scoring range of 0-40, with Since COPD is a progressive disease, a fi xed target score for all patients cannot be set. In Practice, a target for improvement in individual patient CAT scores may be set, based on an holistic assessment of the patient. A change of 2 units suggests a meaningful difference. This test should be used in conjunction with the mMRC and forced expiratory volume in one second (FEV1) to determine COPD health assessment of participants.

  3. modified Medical Research Council (mMRC) Dyspnea Scale [ Time Frame: Screening, weeks 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To evaluate respiratory breathlessness symptoms (Grade 0-4, with Grade 0 being breathlessness with strenuous exercise to Grade 4 being breathlessness for daily activities like dressing). The mMRC Dyspnea Scale score must be contextualized with an individual patient's history, physical, and available diagnostic test results. For patients with a higher mMRC grade (e.g. ≥2) and clinical circumstances consistent with respiratory disease, measuring spirometry (e.g., FEV₁ and FVC), determining the patient's Body-mass index, airflow Obstruction, Dyspnea, and Exercise (BODE) Index and/or GOLD stage, and pursuing further targeted diagnostic and/or therapeutic interventions is appropriate. A patient's mMRC Dyspnea Scale score, or another dyspnea measurement, such as the COPD Assessment Test (CAT), is combined with the patient's FEV₁ percent predicted and the frequency of COPD exacerbations to guide treatment interventions

  4. Visual analogue score (VAS) total and individual dyspnoea, cough, sputum production (100mm) scores [ Time Frame: Weeks 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To evaluate respiratory symptoms. The participant is asked to place a mark (X) on the scale at the point that best describes their health currently. Minimum score 0mm (better outcome), maximum score 100mm (worse outcome) for each section of the scale (dyspnoea, cough, sputum).

  5. Sputum purulence colour card [ Time Frame: Screening, week 12, 28, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To evaluate respiratory symptoms and verify a bacterial cause of an exacerbation

  6. Pre and post bronchodilator (BD) spirometry [ Time Frame: Week 0 and Week 60, withdrawal and exacerbation visits ]
    To assess lung function

  7. Post BD FEV1 Spirometry [ Time Frame: Screening, Weeks 4, 12, 24, 36, 48 and 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess lung function

  8. Body plethysmography 'Body Box' [ Time Frame: Between weeks 0-12 ]
    To assess lung function

  9. Transfer factor [ Time Frame: Between weeks 0-12 ]
    To assess lung function

  10. Sputum biomarkers- mediator profiling [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    % eosinophils which is an established biomarker for eosinophilic airways disease

  11. Differential Cell Count [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Differential Cell Count to assess inflammation at exacerbation events.

  12. Differential Cell Count [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Differential Cell Count to assess infection profile at exacerbation events.

  13. Nasosorption [ Time Frame: Screening, Weeks 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess airway inflammation

  14. Nasal Epithelial Sampling (optional) [ Time Frame: Screening, Weeks 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess airway inflammation

  15. Breath volatile organic compound (VOC) profiling (PTRMS & ADVION) [ Time Frame: Screening, Weeks 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Breathomics

  16. Sputum quantitative real-time polymerase chain reaction (qPCR) bacteria and viruses [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess airway ecology

  17. Microbiome [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess airway ecology. the pulmonary microbial community consisting of a complex variety of microorganisms found in the lower respiratory tract particularly on the mucous layer and the epithelial surfaces. These microorganisms include bacteria, fungi, viruses and bacteriophages. We will be measuring the abundance or lack of them at defined visits to assess the effect of the trial drug on the microbiota (pleural of microbiome). We will do this using qPCR.

  18. Total immunoglobulin E (IgE) & Radioallergosorbent (RAST) [ Time Frame: Screening ]
    (HDM, pollen, cat, dog) To assess systemic inflammation

  19. Urine sample [ Time Frame: Screening, weeks 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Biomarkers of inflammation, to assess systemic inflammation. N-Formyl-methionyl-leucyl-phenylalanine (fMLP) in ng/mL, Club Cell protein 16 (CC16) In ng/mL, CRP in ng/mL, Alpha 1 Anti-Trypsin (A1AT) in ng/mL, Matrix Metalloproteinase 8 (MMP8) in ng/mL

  20. Serum/Plasma Inflammatory Biomarkers [ Time Frame: Screening, weeks 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess systemic inflammation. Plasma/ serum biomarkers are exploratory and we do not have a specific list of biomarkers yet.

  21. Non-contrast CT scan [ Time Frame: Weeks 0 and 60 ]
    Airway morphometry and lung densitometry

  22. Sputum for Biomarkers [ Time Frame: Weeks 0 , 4, 12, 24, 26, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Severity, inflammatory and infection profile at exacerbation events

  23. Differential Cell count [ Time Frame: Weeks 0 , 4, 12, 24, 26, 48, 60 and unscheduled visit(s) at any time point between 0-60 weeks ]
    Severity, inflammatory and infection profile at exacerbation events. Differential cell count in sputum will be eosinophils, neutrophils, macrophages and lymphocytes in absolute numbers and %.

  24. Targeted qPCR (bacteria and viruses) for common airway pathogens [ Time Frame: Weeks 0 , 4, 12, 24, 26, 48, 60 and unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess airway infection and ecology. The unit will be gene copies/ sample.

  25. Microbiome [ Time Frame: Weeks 0 , 4, 12, 24, 26, 48, 60 and unscheduled visit(s) at any time point between 0-60 weeks ]
    To assess airway infection and ecology

  26. Full blood count (FBC) [ Time Frame: Screening, week 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Blood Biochemistry

  27. Urea and electrolytes (U&Es) [ Time Frame: Screening, week 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    To provide essential information on renal function, principally in excretion and homoeostasis.

  28. C-reactive protein (CRP) [ Time Frame: Screening, week 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Blood Biochemistry

  29. Liver function tests (LFTs) [ Time Frame: Week 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Blood Biochemistry

  30. Glycated hemoglobin (HbA1c) [ Time Frame: Screening, week 12, 24, 36, 48, 60 ]
    Blood Biochemistry

  31. N-terminal prohormone of brain natriuretic peptide (NTproBNP) [ Time Frame: Screening, week 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Blood Biochemistry

  32. RNA (PAXgene) [ Time Frame: Week 0, 4, 12, 24, 36, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Genetic analysis to investigate whether there are links between response to treatment for COPD and peoples' genetic make-up

  33. DNA (PAXgene) [ Time Frame: Screening ]
    Genetic analysis to investigate whether there are links between response to treatment for COPD and peoples' genetic make-up

  34. Lipid Profile [ Time Frame: Screening, week 60 ]
    Blood Biochemistry

  35. Single Nucleotide Polymorphisms (SNPs) [ Time Frame: Week 0 ]
    Pharmacogenetics

  36. Pharmacokinetic (PK) analysis [ Time Frame: Week 0, 24, 48 and unscheduled visit(s) at any time point between 0-60 weeks ]
    Pharmacokinetics, PK samples should be taken pre-dose at dosing visits. We will be measuring the Cmax (peak concentration after drug administration in mg/L)

  37. Pharmacokinetic (PK) analysis [ Time Frame: Week 0, 24, 48 and unscheduled visit(s) at any time point between 0-60 weeks ]
    We will be measuring the tmax (time to reach Cmax in mins or hours)

  38. Pharmacokinetic (PK) analysis [ Time Frame: Week 0, 24, 48 and unscheduled visit(s) at any time point between 0-60 weeks ]
    We will be measuring the Cmin (the lowest concentration a drug reaches before the next dose, in mg/L).

  39. Antidrug antibody (ADA) Level [ Time Frame: Week 0, 60 and unscheduled visit(s) at any time point between 0-60 weeks ]
    Pharmacokinetics; The analysis of the impact of antibody status on drug pharmacokinetics (PK)

  40. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Adverse event (AE) event rate per year in the 48 weeks of the trial from first dose. AEs will be recorded throughout the study whether serious or not. Members of the research team will ask the participants about AEs at each study time point.

  41. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Serious adverse event (SAE) event rate per year in the 48 weeks of the trial from first dose.

  42. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Monitoring and analysing of all potential cases of anaphylaxis. Separate reporting forms have been provided by Genentech to capture these which will also be captured on the trial database.

  43. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Monitoring and analysing of all potential cases major adverse cardiac events (MACE). Separate reporting forms have been provided by Genentech to capture these which will also be captured on the trial database.

  44. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Cardiac safety will be evaluated through monitoring of vital signs: blood pressure

  45. Safety and tolerability [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Cardiac safety will be evaluated through monitoring of vital signs: temperature

  46. Safety and tolerability [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Cardiac safety will be evaluated through monitoring of vital signs: heart rate

  47. Safety and tolerability [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Cardiac safety will be evaluated through monitoring of vital signs: Oxygen saturation (SPO2)

  48. Safety and tolerability [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ]
    Respiratory safety will be evaluated through monitoring of vital signs: respiratory rate

  49. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Screening, unscheduled visit ]
    Cardiac safety will be evaluated through ECG assessments

  50. Safety and tolerability [ Time Frame: Screening, unscheduled visit ]
    Cardiac safety will be evaluated through ECG assessments

  51. Safety and tolerability of SC doses of anti-ST2 compared to placebo in adult patients with moderate to very severe COPD [ Time Frame: Screening, Weeks 0, 4, 12, 24, 36, 48, 60, withdrawal, unscheduled visit ]
    Clinical laboratory assessments

  52. Pulse [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Vital Signs

  53. Blood Pressure [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Vital Signs. Both Systolic and diastolic BP will be assessed.

  54. Temperature (degrees centigrade) [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Vital Signs

  55. Oxygen saturation [ Time Frame: Screening, Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, unscheduled visit(s) at any time point between 0-60 weeks ]
    Vital Signs

  56. Airway morphometry and lung densitometry [ Time Frame: Any unscheduled visit(s) due to an exacerbation event at any time point between 0-60 weeks ]
    Chest x-ray and non-contrast CT Scan

  57. Clinical care at exacerbation [ Time Frame: Any unscheduled visit(s) due to an exacerbation event at any time point between 0-60 weeks ]
    Chest x-ray will be done as part of clinical care at exacerbation visits only to find out the cause of patients' symptoms.

  58. 12 lead Electrocardiogram (ECG) [ Time Frame: Screening, week 60 and unscheduled visit(s) at any time point between 0-60 weeks ]
    Cardiac function

  59. Echocardiogram (ECHO) [ Time Frame: Week 0 and unscheduled visit(s) at any time point between 0-60 weeks ]
    Cardiac function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Symptoms typical of COPD when stable (baseline mMRC dyspnoea score ≥ 2)
  2. GOLD COPD stage 2-4
  3. Smoking pack years ≥ 10 years
  4. Age > 40 years
  5. Receiving standard-of-care drug therapy as per British Thoracic Society (BTS) guidance for COPD
  6. A history of ≥ 2 moderate-to-severe exacerbations in the last 12 months.
  7. Be able to give valid written consent; compliant with study procedures and study visits.
  8. Able to understand written and spoken English

Exclusion Criteria:

  1. Significant known respiratory disorders other than COPD that in the view of the investigator will affect the study
  2. Patients whose treatment is considered palliative (life expectancy <12 months)
  3. Known hypersensitivity to the active substance of the investigational product (IP) or any of the excipients
  4. Known history of anaphylaxis
  5. Patients with a COPD exacerbation and/or pneumonia within the 4 weeks prior to visit 1
  6. Have, in the opinion of investigator, uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure [e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnoea), and class IV (e.g. Symptoms of heart failure at rest)] that will affect the study.
  7. Myocardial infarction, unstable angina or stroke within 12 month prior to screening
  8. Diagnosis of malignancy within 5 years of visit 1 (except for excised localised carcinoma of skin not including malignant melanoma)
  9. Clinically significant ECG changes, which in the opinion of investigator warrants further investigations
  10. Laboratory abnormalities, which in the opinion of investigator warrants further investigations
  11. Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
  12. Pregnant, breastfeeding, or lactating women. Women of child-bearing potential (i.e. not surgically sterilised or post- menopausal) must have a negative blood serum pregnancy test performed at the screening visit and must agree to use two methods of birth control, (one of which must be a barrier method).
  13. Participation in an interventional clinical study within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half- lives.
  14. Upon questioning the patient has blood born infection (e.g. HIV, hepatitis B or C)

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): NCT03615040


Contacts
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Contact: Niamh Quann, Ms 0116 229 7243 niamh.quann@leicester.ac.uk
Contact: Ahmed Yousuf, Dr 0116 258 3370 ajy7@leicester.ac.uk

Locations
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United Kingdom
Biomedical Research Centre- Respiratory, Glenfield Hospital Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Ahmed Yousuf, Dr    0116 258 3692    ajy7@leicester.ac.uk   
Contact: Sarah Parker, Ms    0116 258 3277    sarah.e.parker@uhl-tr.nhs.uk   
Principal Investigator: Chris Brightling, Prof         
Sponsors and Collaborators
University of Leicester
Biomedical Research Centre- Respiratory (Glenfield Hospital, Leicester UK)
Leicester Clinical Trials Unit
Genentech, Inc.
Investigators
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Principal Investigator: Christopher Brightling, Prof University of Leicester

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03615040     History of Changes
Other Study ID Numbers: 0671
2018-000919-24 ( EudraCT Number )
GB40568 ( Other Grant/Funding Number: Genentech )
U1111-1210-1335 ( Other Identifier: WHO Universal Trial Number )
244758 ( Other Identifier: IRAS Number )
18/EM/0189 ( Other Identifier: East Midlands - Leicester South Research Ethics Committee )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Leicester:
COPD
Exacerbations
ST2 MAb
RG6149
MSTT1041A
Anti-ST2
Phase IIa
Placebo controlled