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A Study to Compare Safety and Efficacy of an Active Drug to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Brief summary

This is a phase 3, randomized, multi-center study that will evaluate an active drug versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.

Interventional study

Status:
Active, not recruiting
Conditions:
Atopic Dermatitis
Enrollment:
650 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-046
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion Criteria:

- Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface
Area (BSA) and pruritus.

- Participant is a candidate for systemic therapy or have recently required systemic
therapy for AD.

Exclusion Criteria:

- Participant has prior exposure to Janus Kinase (JAK) inhibitor.

- Participant has prior exposure to dupilumab.

- Participant is unable or unwilling to discontinue current AD treatments prior to the
study.

- Participant has requirement of prohibited medications during the study.

- Participant has other active skin diseases or skin infections requiring systemic
treatment or would interfere with appropriate assessment of AD lesions.

- Female participant who is pregnant, breastfeeding, or considering pregnancy during the
study.

All the cities where the clinical studies are located

Calgary - T1Y 0B4

Calgary - T2G 1B1

Surrey - V3R 6A7

Surrey - V3V 0C6

London - N6H 5L5

Markham - L3P 1X2

Mississauga - L5H 1G9

Toronto - M2M 4J5

Waterloo - N2J 1C4

St-Jerome - J7Z 7E2