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Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis

Study acronym: PROTYPE2
StatusActive, Not Recruiting
PhaseNot specified
SponsorSanofi
Started
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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Final enrollment: 572 participants (planned 900)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 28 of 46 entries
    • Site details revised at 55 of 55 sites
  2. Eligibility criteria shortened, about 8 wordsv5
  3. Primary completion date: Mar 5, 2025 to Mar 8, 2028
    • Study completion date: Mar 8, 2027 to Mar 8, 2028
    v4
  4. Study sites: 1 to 55
    • Start date: Mar 6, 2023 to Mar 7, 2023
    v3
  5. Primary endpoints revised (3)
    • Study title shortened, about 1 word
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
Atopic Dermatitis
500 trials monitored
See 16 trials at risk
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.
Trial Details
NCT Number NCT06039241
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Atopic Dermatitis
Related terms Dermatitis, Atopic
Enrollment 572 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov