Measure Up 1

Evaluation of an Active Drug in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1

Brief summary

The objective of this study is to assess the efficacy and safety of an active drug for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy.

Interventional study

Status:
Recruiting
Conditions:
Atopic Dermatitis
Enrollment:
905 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-045
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 12 Years to 75 Years.

Inclusion Criteria:

- Body weight of >= 40kg at Baseline Visit for participants between >= 12 and <18 years
of age

- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline
Visit

- Active moderate to severe AD defined by Eczema Area and Severity Index (EASI),
Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus

- Candidate for systemic therapy or have recently required systemic therapy for AD

- Documented history of inadequate response to topical corticosteroids (TCS) or topical
calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months
before Baseline Visit

Exclusion Criteria:

- Prior exposure to any Janus kinase (JAK) inhibitor

- Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to
the study

- Requirement of prohibited medications during the study

- Other active skin diseases or skin infections requiring systemic treatment or would
interfere with appropriate assessment of atopic dermatitis lesions

- Female subject 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

St. John's - A1A 4Y3

Hamilton - L8S 4K1

London - N6H 5L5

Markham - L3P 1X2

Ottawa - K2C 3N2

Waterloo - N2J 1C4

Montreal - H3H 1V4

Montréal - H2X 2V1

St-Jerome - J7Z 7E2

Fredericton - E3B 1G9

Winnipeg - R3M 3Z4

Alberta

British Columbia

Manitoba

New Brunswick

Newfoundland and Labrador