Generalized Pustular Psoriasis (GPP) Rescue Case Study

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PPP rescue case study

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Outcomes

Innovaderm successfully transitioned this rescue study from another CRO and this resulted in:

More than doubled patient enrollment in 1 month
Started enrollment 1 month faster than initial projection
All 5 newly added sites were actively recruiting

 

Study Characteristics

  • Study Phase: IIa
  • Study Type: Rescue study
  • Patient Population: Generalized Pustular Psoriasis (GPP)
  • IP Route of Administration: Systemic
  • Original Sites at Rescue: 7 in 2 continents (4 North America, 3 Europe)
  • Post Rescue Final Sites Distribution: 10 in 3 continents (7 Europe, 2 North America, 1 Asia)

 

 

Study Challenges

    • GPP is the rarest form of psoriasis - Global prevalence of 1-9/1,000,000
    • Patients had to be in flare in order to meet eligibility
    • Most patients in North America and Central Europe well-managed on current SOC
    • Only 2/7 legacy sites had recruited subjects - Only 30% of subjects enrolled when Innovaderm took over management
    • Non-recruiting sites did not have target patient population in current clinical practice
    • Global and regional Phase III trials competing for same population

 

 

Key Success Factors & Strategies

Site selection symbol Country and site selection

Site activation PI Training

Site engagement Site Engagement

Phone interview icon Regulatory Affairs

Phone interview icon Study Branding

 

Conclusion

    • Extensive site and partner network: To identify the right sites in the right countries
    • Years of experience with dermatology sites: To assess and rank sites based on recruitment & data quality and to focus on the sites most likely to make a difference in recruitment & assure data quality

 

Within a month of the new sites opening in Europe and Asia:

    • Enrollment rates had more than doubled
    • None of the legacy sites contributed to new enrollment
    • Amid COVID, the Innovaderm team was able to activate two new countries in Europe and Asia, and complete enrollment faster than planned

       

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