On this page you can find out about the studies currently being delivered and upcoming studies that will be opening at our centre soon. 

Open Studies (17)

  • REDEFINE 3

    Study date: 09 May 2023

    Status: Open

    The study, REDEFINE 3, is looking at a combination of two medicines. REDEFINE 3 is needed to help us understand how effective these two medicines are for reducing cardiovascular events, such as heart attacks and stroke. This study is funded and sponsored by Novo Nordisk. 

    This study is open at PRC: Bradford, PRC: Leicester, PRC: Exeter. And upcoming at PRC: Blackpool and PRC: Newcastle.

    To find out more about the REDEFINE-3 study, please visit www.redefine3.org.uk or contact the team: prc@nihr.ac.uk

  • VICTORION PLAQUE

    Study date: 08 December 2022

    Status: Open

    This is a clinical trial for patients diagnosed with non-obstructive coronary artery disease. The purpose of this research study is to determine if the study treatment, called inclisiran, taken in addition to statin medication can safely and effectively reduce the total amount of plaque formed in the heart’s vessels. The study will also focus on understanding how your body reacts to the study treatment as well as identifying the patients who would most likely benefit from this treatment using biomarker analysis.

    If you take part in the study, you will either receive the study treatment or a placebo, both of which will be given as an injection. You will be in the study for about 24 months and, during that time, will need to have between 8-12 study visits (either in person at the study site, by telephone, and/or at home). During the first 9 months of the trial, you will need to have between 5-8 study visits (either at the study site, by telephone, and/or at your home), depending on the type of statin medication you are currently taking.

    This trial is open at PRC: Newcastle and upcoming at PRC: Exeter and PRC: Bradford.

    To find out more, contact us on nuth.PRCNewcastle@nhs.net.

  • LPS16676 Asthma Lung Function Decline Study

    Study date: 09 June 2022

    Status: Open

    This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

  • BP43464_COMBO

    Study date: 30 May 2022

    Status: Open

    Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7200220 in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 52 weeks.

  • BP43445_MONO

    Study date: 30 May 2022

    Status: Open

    This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.

  • Genentech_GB43311

    Study date: 25 May 2022

    Status: Open

    This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

  • GSK 206713 SWIFT-1

    Study date: 20 May 2022

    Status: Open

    This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype.

  • ACT17208

    Study date: 03 March 2022

    Status: Open

    This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on inhaled ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol [non-investigational medicinal product], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period.

  • TITANIA

    Study date: 07 February 2022

    Status: Open

    The purpose of this Phase III study is to evaluate the efficacy and safety of Tozorakimab (MEDI3506) Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of = 2 moderate or = 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not indicated or contraindicated) at a stable dose for at least 3 months prior to enrolment.

  • BESRA

    Study date: 09 December 2021

    Status: Open

    BESRA is a national, multi-center, prospective, observational study to assess the effectiveness of brolucizumab intravitreal injections in patients with nAMD treated in the UK.

  • Benralizumab Exacerbation Study

    Study date: 29 November 2021

    Status: Open

    A phase IV, open-label, prospective, multi-centre cohort study in patients with severe eosinophilic asthma (Global Initiative for Asthma [GINA] steps 4 and 5 classification of asthma severity) who will be treated with benralizumab injections. The study is exploratory and will assess deteriorations in asthma control (exacerbations) to characterise the clinical severity of each exacerbation and the airway and systemic inflammatory phenotype associated with these events. Clinical assessment and management of each exacerbation will be in line with standard clinical guidelines. 150 participants will be recruited and receive treatment for either 56 or 80 weeks.

  • PILAR

    Study date: 25 November 2021

    Status: Open

    The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population. (PILASTER)

  • PILASTER

    Study date: 25 November 2021

    Status: Open

    The purpose of this study is to obtain information on the efficacy (effectiveness) and the safety of two doses of CHF6001, a product developed by Chiesi Farmaceutici S.p.A. for the treatment of Chronic Obstructive Pulmonary Disease (COPD). (PILAR)

  • NIMBLE

    Study date: 31 August 2021

    Status: Open

    A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinphilic phentoype treated with GSK3511294 compared with mepolizumab or benralizumab

  • AERIFY-2

    Study date: 29 July 2021

    Status: Open

    Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)

    The purpose of the study is to investigate the effect, safety, and tolerability of the study drug for the treatment of patients with COPD, who continue to have symptoms on current treatment, and who are in need of an additional treatment to their current COPD management (standard of care SoC ). Simply put, we want to see if adding the drug on top of your current treatments improves COPD outcomes/exacerbations, therefore this study treatment will be given in addition to your current controller therapy.

    The study is a multicentre study conducted worldwide. It will last approximately 72 weeks and will include 1170 participants, some ex-smokers, some ongoing smokers. Of those, about 740 participants will receive study drug itepekimab and about 430 participants will receive placebo (substance looks exactly like itepekimab but is not medically active). If you provide consent to participate, you will undergo study activities described in the following sections. During the study, the term “study treatment” will refer to either itepekimab or placebo.

    This study is randomised, meaning study treatment will be assigned to you on a random basis (like flipping a coin). Your chance of receiving active treatment (itepekimab) if you are a former smoker at study start is 2 out of 3. Your chance of receiving active treatment (itepekimab) if you are a current smoker at study start is 1 out of 2. The study is also “blinded”, which means that both you and the study doctor will not know in which treatment group you are included and which study treatment you are receiving (itepekimab or placebo). However, in an emergency the exact treatment can be identified.

  • STIFLE

    Study date: 21 July 2021

    Status: Open

    This is a randomised, active-comparator, open-label, parallel-group, multicentre phase IV exploratory study to characterise changes in airway inflammation, symptoms, lung function, and reliever use in asthma patients using SABA (salbutamol) or anti inflammatory reliever (SYMBICORT®) as reliever medication in addition to SYMBICORT as daily asthma controller. Eligible patients diagnosed with asthma at least 6 months prior to the Screening Visit (Visit 1) and fulfilling all of the inclusion criteria and none of the exclusion criteria will continue into the Run-in Period. At Visit 2, patients will be assessed for randomisation criteria and, if met, will be randomised to receive either SYMBICORT as maintenance and reliever treatment or SYMBICORT as maintenance treatment and salbutamol as reliever treatment in a 1:1 ratio. Randomisation will be stratified by the patient's ongoing dose of inhaled corticosteroids [(ICS) low or medium] or long-acting ß2-agonist (ICS/LABA) at study entry.

  • DAPA-MI

    Study date: 07 April 2021

    Status: Open

    The DAPA-MI study is evaluating if dapagliflozin (a drug developed to treat diabetes) can also be effective in reducing the risk of heart failure and death following a heart attack. This is a multicentre, parallel group, event-driven, registry-based randomised controlled trial (R-RCT), double-blind, placebo-controlled phase 3 study. Dapagliflozin, which is given once daily in addition to Standard of Care therapy, will be evaluated versus placebo for the prevention of hospitalisation for heart failure or cardiovascular death.

Upcoming Studies (7)

  • MiSTIC

    Study date: 07 September 2022

    Status: Upcoming

    The purpose of this phase IV Study is to demonstrate the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) on uncontrolled asthma subjects, compared to CHF1535 (BDP/FF 200/6 pMDI).

  • ProKidney - REACT

    Study date: 01 September 2022

    Status: Upcoming

    The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT® injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.

  • CVAY736K12301 Lupus Nephritis

    Study date: 31 August 2022

    Status: Upcoming

    This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).

  • EP395-003

    Study date: 31 August 2022

    Status: Upcoming

    EP395 is a macrolide with anti-inflammatory and barrier protective properties, but without antibacterial effects. It is being developed as a treatment for COPD, to reduce exacerbations. The proposed study will assess the safety and tolerability of 3 months treatment in patients with COPD. The study will also assess the anti-inflammatory effects of EP395 in sputum. Exploratory endpoints will also be included with the aim to further understand mechanistic activity of EP395.

  • WAYFINDER

    Study date: 31 July 2022

    Status: Upcoming

    This is a multicentre, single-arm, phase 3b study designed to evaluate efficacy and safety of reducing daily oral corticosteroid use after initiation of 210 mg dose of Tezepelumab administered subcutaneously in patients with severe asthma receiving high-dose inhaled corticosteroid plus long-acting ß2 agonist and oral corticosteroids with or without additional asthma controller medications.

  • OHANA

    Study date: 31 July 2022

    Status: Upcoming

    The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations.

  • Efficacy and Safety of Dupilumab in Participants with ABPA

    Study date: 30 July 2022

    Status: Upcoming

    The primary objective of the study is to evaluate the efficacy of dupilumab on the annualized rate of exacerbations in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).