ImmunAID is seeking to enable a rapid and accurate diagnosis across all the spectrum of SAID, in order to improve clinical management of SAID patients, through a graded approach:
- Identification and validation of novel Omics- and pathway-based diagnostic biomarkers, with a strong link to pathogenic pathways involved in autoinflammation, and likely to be considered as genuine “autoinflammation signatures”;
- Development of a robust clinical decision algorithm to assist physicians, having a progressive and targeted approach (triage process) when facing a patient with suspected SAID, and thus avoiding the prescription of a large number of costly and frequently inadequate diagnostic investigations in parallel;

The ImmunAID research will likely lead to the reorganization of SAID into a new comprehensive and pathogenesis-driven classification with strong clinical impact.

Population: adult & paediatric

The study will be a multi-national, multi-centre longitudinal observational study with the aim to evaluate the performance of the candidate digital endpoints of fatigue and sleep disturbance in the following neurodegenerative disorders (Parkinson’s disease and Huntington’s disease) and immune-mediated inflammatory diseases (Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and primary Sjögren’s syndrome). Healthy volunteers without symptoms of chronic fatigue or sleep disturbance will also be include as a comparative group.

Population: adult | Intervention type: therapeutic medical device

The main goal of HIVACAR is to change the current paradigm of HIV treatment by obtaining a functional cure for HIV (i.e., control of viral load to levels below the threshold of 50 copies/ml and maintenance of high CD4+ T-cell count after discontinuation of antiretroviral therapy) thanks to effectively targeting residual virus replication and viral reservoirs. In order to do so, the planned novel strategy is to successfully combine immune-based therapies, including therapeutic vaccines and broadly neutralizing antibodies with latency reversing agents, in a proof-of-concept phase IIa clinical trial.

The HIVACAR project will lead to a reduction of the actual costs related to HIV treatment and management and of the social public health as well as an improvement in the patients’ quality of life. HIVACAR has been conceived under the framework of responsible research and innovation, so patients and other stakeholders will have a key role from the inception of the project until obtaining the results. Patients will be perfectly aware of how this therapy has been conceived and the real impact and change in their actual quality of life, as well as how the clinical trial has been designed and the consequences of participating in it. In addition, patients (and the general population) will tailor the project and its results dissemination and communication. This patient engagement will not be limited to the clinical trial but also to the rest of the activities of the project, so patients and the general society will be aware of how the research is developed and can include the patients’ point of view in the research activities. In addition, the socio-economic and psycho-social impact of the new treatment will be also analysed so overwhelming data on the benefits and impact of the new treatment will be obtained and shown to all stakeholders.

Population: adult | Intervention type: therapeutic medicinal product

This randomized trial is based on the hypothesis that the combined use of (1) biomarkers including non‐invasive biomarkers in peripheral blood and urine predicting anti‐donor immunological activation or quiescence, and high/low risk clustering using the transcriptional changes in allograft tissue samples using gene expression assessment and (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow‐up of kidney transplant patients without the need for invasive surveillance allograft biopsies to assess allograft rejection in clinically stable kidney transplant patients. We therefore propose a with/without, European, multicenter, prospective randomized and biomarker‐guided trial.

Population: adult | Intervention type: therapeutic medicinal product

The EU-TRAIN project was formed by gathering reference kidney transplant centres in a fully operating European network including 12 partners. Our ambitious but realistic goals are: to provide clinicians with innovative and accessible tools for early prediction of individual risk of allograft rejection and transplant loss; to personalise clinical management and treatment and; to improve allograft outcomes.
This project will engineer a risk stratification system applied to kidney transplant patients by analysing the integration of several layers of data (clinical, histological, immunological data as well as gene expression and novel biomarkers) - the TRAnsplant Comprehensive Evaluator of Risk (EU-TRACER). EU-TRACER will be generated and validated in two dedicated studies including a randomised control trial.

Population: adult | Intervention type: non-interventional

The EU-SolidAct trial – European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial – is part of EU-RESPONSE, a pan-European research project involved with the rapid and coordinated investigation of medications to treat COVID-19 during the ongoing pandemic. The EU-SolidAct (EudraCT: 2021-000541-41; clinicaltrials.gov ID NCT04891133) is a multi-center, randomized, adaptive Phase 2 and 3 platform trial, the master protocol of which has been developed to evaluate potential treatments in hospitalised patients with COVID-19, the disease caused by the SARS-CoV2 virus (coronavirus). Under the trial, bemcentinib will be studied in up to 500 hospitalised COVID-19 patients. In support of the trial, BerGenBio will provide bemcentinib drug material and incremental funding of costs related to the bemcentinib sub-protocol. 

The first drug studied under the EU-SolidAct platform was baricitinib, marketed by Eli Lilly and Company, and is now under market authorisation evaluation by the EMA (European Medicines Agency) for use in hospitalised COVID-19 patients.  BerGenBio’s AXL inhibitor, bemcentinib, has been selected by an international expert group to be the second compound to be studied in the EU-SolidAct platform.

EU-SolidAct has established clinical sites in 15 countries. The trial is sponsored by Oslo University Hospital, Norway in collaboration with the Institut National de la Santé Et de la Recherche Médicale (Inserm), France and the not-for-profit intergovernmental organization European Clinical Research Infrastructure Network (ECRIN). The trial through the EU-RESPONSE project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101015736. Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants.

Population: adult

The overarching objective is to evaluate anti-SARS-CoV-2 immune responses to different booster strategies in individuals already vaccinated against SARS-CoV-2. Specifically, this subprotocol will determine the need for, optimal timing of and immunogenicity of administering a 4th homologous vaccination dose against SARS-CoV-2 in the general population (18+ years) who have already been vaccinated with three doses of the BNT162b2 vaccine.

Population: adult | Intervention type: vaccine

A randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the elderly, a usually neglected population.
Additional vaccines and extended follow-up visits can be added through amendments of this sub-protocol. As stated in the EU-COVAT master protocol, this trial, i.e., the EU-COVAT-1_AGED study, implements a specific safety monitoring strategy .

Population: adult | Intervention type: vaccine

Cerebral palsy (CP) results from a lesion to the brain that occurs before or around birth, and it is the most common cause of physical disability in childhood. Approximately 70% of children with CP are able to walk, but experience varying degrees of restrictions related to this function. In children with CP, walking speed is reduced, balance is impaired and energy cost during walking is increased. Consequently, children with CP are less active and restricted in social participation compared to their peers. During the last two decades, targeted muscular injections of botulinum toxin A (BoNT-A) have become the standard treatment to reduce spasticity with the intention to make walking easier in order to facilitate the children's activity level and participation. Treatment with BoNT-A is mainly offered to children. Already at the age of 6 years, approximately 60% of the Norwegian children with CP have been treated with BoNT-A; mainly in the lower limbs. The evidence for a functional effect is surprisingly limited, despite the fact that this drug has been used for 20 years. The drug is expensive not only in terms of drug expenses, but also personal costs as well as the costs for the patients and their families. The objective of the study is to evaluate whether injections of BoNT-A in the calf muscles (mm.gastrocnemius and soleus) make walking easier in children/adolescents with CP within a time span of 6 months, and to evaluate whether an improvement in energy cost during walking is associated with increased daily activity, increased walking capacity, less pain and perceived improved performance and satisfaction. It is a double blinded placebo controlled randomized parallel-group design Phase IV study. This study cordinated by Professor Torstein Vik and sponsored by St. Olavs University Hospital, Trondheim Norway. Study will be conducted in three european countries (Norway, Poland and France).

Population: paediatric