Survivors of childhood cancer experience impaired health-related quality of life, psychological distress, and pain. A previously developed body mindset intervention has improved health-related quality of life and symptom distress in adult cancer patients. In the current research, we will examine whether a body mindset intervention can instil adaptive body mindsets, boost resilience, and improve physical and psychological functioning in survivors of childhood cancer. Survivors of childhood cancer will be randomised to the body mindset intervention or an active attention control group. ...

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Controlling persistent pain is a significant unmet need for people living with Inflammatory arthritis (IA). There is emerging evidence that patients with IA exhibit different types of pain and central sensitisation contributes significantly to chronic pain. The treatment for different pain types will differ. One way in which we might rapidly improve the treatment of pain in IA is by identifying an individual’s pain type in the clinic, then tailor their pain treatment accordingly. Currently this is not routine practice and ...

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This is a Phase III double-blind, randomised, placebo-controlled, adaptive design study, to assess whether the addition of AZD5305 to physician’s choice NHA improves treatment outcomes of patients in the setting of mCSPC. A schema summarising the key elements of the study design is shown in Figure 1. A total of 1200 participants will be randomised (in a 1:1 ratio) to receive either AZD5305 (600 participants) or matching placebo (600 participants), in combination with physician’s choice of NHA (abiraterone, darolutamide, or enzalutamide) ...

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The FAIM trial is a phase II, multicentre, randomised trial in patients with hormone-receptor (HR) positive and HER2 negative advanced breast cancer, suitable for standard of care fulvestrant+CDK4/6 inhibitor with a known trackable mutation and no contraindication to ipatasertib. The study aims to determine whether adding a new drug called ipatasertib helps breast cancer to be controlled for longer if it is added to a standard combination of the hormone treatment fulvestrant, and the targeted agent palbociclib. Palbociclib is a ...

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Oesophageal squamous cell cancer (OSCC) is a cancer that grows in the food pipe and affects up to 2,000 people in the UK every year. Most patients are diagnosed when the cancer has spread to other body parts (advanced stage). As a result, the five-year survival is less than 20%. In comparison, when diagnosed early, nearly three out of four patients survive more than five years, indicating that early diagnosis improves survival. There are numerous challenges in detecting OSCC early. ...

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The purpose of this study is to evaluate the safety and human clinical response to SARS-CoV-2 challenge with the omicron variant virus, in previously SARS-CoV-2 vaccinated people. We aim to establish the optimal challenge dose that causes re-infection and identify the lowest level of infectious dose necessary to produce viral replication in the upper respiratory tract of research volunteers while minimising risk of disease progression. Investigators aim to achieve an infection model which results in no symptoms, or symptoms no ...

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This is a parallel, Phase 3 study with 2-arms for treatment that are blinded/masked for participants, the Investigator, any Investigator site staff, and the Sponsor. The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy in delaying the disability progression and the safety of up to 48 months administration of frexalimab intravenous (IV) every 4 weeks (q4w) compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time ...

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This is a multicenter Phase 2 study of TL-895 in subjects with MF or ISM. Myelofibrosis (Cohorts 1-4) Treatment for subjects with MF in Cohorts 1-4 will be open-label, with enrollment for each cohort as follows: subjects with R/R MF (Cohort 1), JAKi-intolerant MF (Cohort 2), and MF ineligible for JAKi treatment (Cohort 3 and Cohort 4). Part A will evaluate the safety and tolerability of different doses of TL-895 when administered in different schedules to determine the RP2D for each cohort. Part ...

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Psoriatic arthritis (PsA) is a chronic immune mediated inflammatory arthritis occurring in patients with psoriasis and is usually serum rheumatoid factor negative [1]. PsA affects around 20% of patients with psoriasis, is equally distributed amongst the sexes, has a tendency to be more prevalent in areas distant from the Equator and appears in most patients before age 65 [2, 3]. The disease manifestation can be heterogeneous between subjects, and the resulting musculoskeletal impairment can interfere with physical function as well ...

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This is a multi-centre, open label, FIH, multi-part trial to assess safety, tolerability, and preliminary efficacy of THEO-260 in patients with high grade serous or endometrioid ovarian cancer. The trial consists of 4 parts: Part A, Part B, Part C (optional) and Part D (optional). Part A (Dose Escalation/Finding Part): The trial part will use a model-assisted methodology for dose finding, Bayesian Optimal Interval (BOIN). Four (4) escalating dose levels are planned. In Part A, RP2D will be identified. Up to 18 ...

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