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Investigator Initiated Study Program at LEO Pharma

At LEO Pharma, we are committed to advancing medical knowledge and improving patient care through research. Our Investigator Initiated Studies (IIS) program is designed to support independent research that aligns with our mission and therapeutic areas of interest.

What are Investigator Initiated Studies?

Investigator Initiated Studies are research activities conceived and conducted by independent Investigators or academic institutions. These studies play a crucial role in exploring new scientific insights, treatment approaches, and patient outcomes.

 

Our Commitment

LEO Pharma is dedicated to fostering innovation and scientific excellence. We support IIS through funding and/or study drug supply. The value of Investigator-initiated research is key to complementing LEO Pharma-sponsored studies, helping us better understand the benefit/risk profile of our therapies and explore new opportunities to address unmet medical needs. Our goal is to empower researchers to pursue novel ideas that can lead to significant advancements in dermatology and other therapeutic areas.

 

Research Requirements

LEO Pharma is committed to supporting ethical, independent clinical and non-clinical research conducted by qualified Investigators. Proposed research must offer meaningful scientific objectives and be supported by a valid study design. Additionally, the privacy rights, safety, and welfare of patients and animals must be fully secured.

 

Areas of Interest

We welcome research proposals from qualified investigators in our strategic areas of interest. Proposals that enhance patient care and align with our priorities, listed below, will be considered. For questions or to discuss your study concept, please contact your local LEO Pharma representative.

 

 

Atopic Dermatitis (AD) - Tralokinumab

  1. Studies investigating the long-term real world effectiveness and stability of response of tralokinumab.
  2. Studies addressing intervention with tralokinumab on AD comorbidities, course of disease and pathophysiology (disease modification)
  3. Studies examining how to switch from another systemic therapy to tralokinumab
  4. Studies exploring the patient characteristics, the incidence, rationale, and outcomes (including persistency) of altering the dosing frequency of tralokinumab (every 2 weeks (Q2W) or every 4 weeks (Q4W)).
  5. Studies looking at improved outcomes with optimal initiation of tralokinumab therapy (e.g. Patient Support Program regarding setting expectations, advanced communication tools, guidance for best co-treatment with topicals i.e. pro-active flare management).
  6. Studies exploring difficult to treat areas including head and neck AD.
  7. Impact and assessment of treat-to-target strategies, treatment goals and initiatives to advance quality of care in managing AD

 

AD Out of scope

  1. Mode of Action and basic science studies
  2. Non dermatological indications
 

Chronic Hand Eczema (CHE)- Delgocitinib

  1. Research to improve the understanding of Chronic Hand Eczema (CHE) and its psychological and socio-economic impact on patients and the community.
  2. Mechanistic studies on delgocitinib’s mode of action and its effects on skin, signs, and symptoms in CHE.
  3. Research on the use of delgocitinib in combination with other treatment options for moderate to severe CHE.
  4. Research on the use of delgocitinib for subtypes of CHE and treatment approaches for different patient responses.
  5. Real-world application and outcomes of delgocitinib for moderate to severe CHE. 
 

Psoriasis - Brodalumab

  1. Sub-population studies in specific patient segments (e.g., overweight/obese; psoriasis in hard-to-treat areas; senior/elderly patients, patients with metabolic syndrome)
  2. Studies to investigate patient reported outcomes and patient benefits in patient segments of high interest
  3. Societal burden and economic impact of moderate-severe psoriasis and disease management (incl. health care resource use (HCRU))
  4. Psychological burden of psoriasis for moderate-severe patients, socio-economic parameters and Work impairment.  
 

Psoriasis - Calcipotriol/betamethasone foam

  1. Studies which are investigating the current in label population and indication: Adults, plaque psoriasis, effectiveness. 
  2. Benefit of the fixed-dose combination and fast onset of action
  3. Importance of topicals in psoriasis plaque improvement
  4. Patient journey Health Related Quality of Life (HRQoL), Patient benefit, Compliance/Adherence, Physician/Patient Preference
  5. Early (topical) treatment initiation for mild & moderate psoriasis patients in treatment pathway
  6. Burden of disease incl. mild psoriasis, economic impact & work impairment 
 

Thrombosis - Tinzaparin

  1. Studies assessing outcomes of using tinzaparin for extended (up to 4 weeks) post cancer surgery, using 4,500 IU.
  2. Studies assessing tinzaparin treatment outcomes in particular cancer tumor types and/or co-morbidities or co-medications (e.g. anaemia, obesity, thrombocytopenia, renal/liver dysfunction).
  3. Prophylaxis using tinzaparin 4,500 IU in a medical patient population (e.g.,hospitalized, non-surgical, immobile patients).

How to Apply

Researchers interested in submitting a proposal for an Investigator Initiated Study can follow these steps:

  1. Prepare your proposal: Include a detailed study plan, objectives, methodology, and budget.
  2. Submit your proposal: Either reach out to your local LEO Pharma representative or send your proposal to IIS_program@leo-pharma.com, please indicate your country of residence/conduct of the IIS
  3. The proposals will be reviewed on a quarterly basis, with the following schedule:
    Q1 Review: Proposals due by February 28, feedback and decision expected by March 31.
    Q2 Review: Proposals due by May 31, feedback and decision expected by June 30.
    Q3 Review: Proposals due by August 31, feedback and decision expected by September 30.
    Q4 Review: Proposals due by November 30, feedback and decision expected by January 31.

    Feedback and decisions will be provided directly to you according to this schedule.