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:
Active, not recruiting
Conditions:
Atopic Dermatitis
Enrollment:
968 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 ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age

- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline Visit and subject meets Hanifin and Rajka criteria.

- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index
(EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body
surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus
numerical rating scale (NRS) ≥ 4.

- Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days
before the Baseline Visit.

- 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 - 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
Saint-Jerome - J7Z 7E2