Atopic Dermatitis (AD) Case Study

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Outcomes

Innovaderm successfully managed this AD study
and this resulted in:

Enrollment completed 2 months earlier than planned;
Innovaderm CRU recruited 33% of patients

Study Characteristics

• • Study Phase: Ib

• Patient Population: 36 subjects with moderate to severe AD
• IP Route of Administration: Systemic - Oral
• Site distribution: 10 sites in 2 countries (USA and Canada)
• Study Design: Randomized, sequential, placebo-controlled, double-blind | Multiple ascending dose (MAD): 3 sequential cohorts
• Study procedures: 4.5 mm punch skin biopsies, photographs, biomarker analysis, skin microbiome, pharmacokinetics, tape stripping and efficacy-safety assessments

Study Challenges

• • Recruitment during summer months; Seasonality impacts on AD flares
  • Short treatment duration; 4-week treatment period
  • Data and Safety Monitoring Board (DSMB) after each cohort; Challenging to manage without affecting recruitment

Key Success Factors & Strategies

Recruitment completed in 6 months vs planned 8 months

Outstanding contribution by Innovaderm's Clinical Research Unit

Recruitment Curve

Enrollment target reached 2 months ahead of schedule

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