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Investigator-Initiated Studies
Investigator-initiated clinical studies can play a key role in answering important medical and scientific questions regarding LEO Pharma's products and their related therapeutic areas. Such clinical studies can contribute towards enhancing the understanding of LEO Pharma's products and their appropriate application, thus improving patient care, and sparking new ideas for further disease-related research aimed at creating improved treatment for patients.
Investigator-initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups. As the trial sponsor, the researcher is responsible for all legal and regulatory obligations associated with the conduct and management of the study, as defined by all applicable laws and regulations.
Eligibility requirements for IIS
LEO Pharma may support investigator-initiated studies with drug supply, funding, material and/or information, as allowed under applicable laws and regulations, provided that they align with the company defined areas of strategic interest.
Types of IIS eligible for support:
- Clinical studies of approved and investigational uses, involving marketed LEO Pharma drugs (interventional studies phase ii to iv)
- Clinical observational studies, real world evidence (non-interventional studies)
- The following types of support are out of scope:
- Non-clinical studies requests
- Requests for compassionate use
The sponsor/investigator has to fulfil (or agree to) the following requirements:
- Have the scientific, technical and operational capabilities to conduct a study as a sponsor, including adequately trained staff to execute a study (GCP, GMP, etc.)
- Have expert statistical support
- Submit a scientifically well designed and well-written study proposal
- Deliver to agreed timelines
- Be able to fulfill all regulatory requirements (including submitting a IND/CTA, writing of final study report and manuscripts etc.)
- Deliver a written report of the final study results to LEO Pharma
- Publish the study in a peer reviewed scientific journal
- Agree to safety reporting to health authorities and to LEO Pharma
- Agree to provide study updates to LEO Pharma
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Disease understanding of atopic dermatitis, including the role of IL-13
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Association of biomarkers in relation to atopic dermatitis
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Skin microbiome in atopic dermatitis
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Insights into tralokinumab safety and efficacy in moderate-to-severe atopic dermatitis patients
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Management of atopic dermatitis and impact of patient-reported outcomes
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MoA of tralokinumab and effects on IL-13 pathway and disease manifestations
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How to apply for IIS support
After registration, researchers are invited to submit their concept proposal via the IIS submission portal. Concept submission will be reviewed collectively by the Medical Strategy and Scientific Affairs Review Committee based on scientific merit and alignment with corporate research and development plans.
The requester will be informed about the outcome and should LEO Pharma be interested in the concept submission, the investigator will be contacted and invited to submit further details and a final protocol on the IIS in order to be considered for full approval.
LEO Pharma requires that the following documents are in place before the support can be initiated:
- a fully executed agreement between the sponsor and LEO Pharma
- an EC/IRB and/or health authority approval
All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.
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