This study is currently closed to recruitment and in follow-up.

20170703 is a study in adult participants with Chronic Migraine (CM) and Medication Overuse Headache (MOH). The purpose of conducting the study is to better understand the effectiveness and safety of erenumab compared to placebo when given to a targeted population diagnosed with CM and MOH that have at least one preventative treatment failure, to see if it makes any changes in the number of days participants suffer from monthly headache days (MHD) and are able to revert the medication overuse status.

Dapagliflozin is a commonly used medicine in diabetes care, it helps control blood sugar and promotes weight-loss. The DETA trial is investigating if this medicine also improves physical health, the ability to undertake daily activities, and whether its effects can be further improved when paired with an exercise programme.

This multi-centre, randomised, observer-blind, active-controlled, superiority study in adults to compares the immunogenicity of Valneva’s VLA2001 COVID-19 vaccine candidate, against the AstraZeneca AZD1222 (ChAdOx1-S) vaccine. VLA2001 will also be compared to placebo in an adolescent population.

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.

The inRange study is comparing two different long-acting insulin injections in patients with type 1 diabetes. The study will use continuous glucose monitoring to compare how long participants are in their goal glycaemic (blood sugar) range. This study is now complete and awaiting publication of results.

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalisation and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has an impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. This clinical trial is a multi-centre, randomised, double-blind, parallel-group, placebo-controlled study.

The RELIEVE IBS-D trial is testing a new treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D).

The MANDALA study is investigating a new drug for people who are currently living with moderate to severe asthma.

The Janssen UK trial team is very pleased to be able to share the most recent publicly available results from the ENSEMBLE (single dose) and ENSEMBLE-2 trials. If you took part in either of the trials, you can find important information about COVID-19 booster vaccines depending on whether you had two doses, one dose, or a placebo (dummy) vaccine below.

Trial results

The main findings from both trials are that a second dose (booster dose) of the Janssen COVID-19 vaccine gives:

• 94 percent protection when the booster is given at two months (results from USA)
• A four times increase in antibodies (immunity) when the booster given at two months
• A 12 times increase in antibodies (immunity) when the booster is given at six months

If you were part of the ENSEMBLE-2 trial and need advice about having a COVID-19 booster vaccine, from Janssen or as part of the NHS vaccination programme, please contact the study team on: Ensemble2_Mailbox@uhl-tr.nhs.uk

A Phase 2/3, Randomised, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalised Adults with COVID-19