AD Up

A Study to Evaluate an Active Drug in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Brief summary

The objective of this study is to assess the efficacy and safety of an active drug combined with topical corticosteroids (TCS) 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:
810 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-047
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 prior to
Baseline Visit

- Active moderate to severe atopic dermatitis 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 atopic
dermatitis

- Documented history of inadequate response to topical corticosteroids or topical
calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to
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

Edmonton - T6G 1C3

St. John's - A1A 4Y3

Halifax - B3H 1Z2

Markham - L3P 1X2

Mississauga - L5H 1G9

Oakville - L6J 7W5

Ottawa - K1H 7X3

Peterborough - K9J 5K2

Richmond Hill - L4B 1A5

Toronto - M3H 5Y8

Toronto - M4W 2N4

Windsor - N8W 1E6

Montreal - H3T 1C5

Quebec City - G1V 4X7

Quebec City - G1V 4X7

St-Jerome - J7Z 7E2