NCT03607422

A Study to Evaluate an Active Drug in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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 AD who are candidates for systemic therapy.

Interventional study

Status:
Recruiting
Conditions:
Atopic Dermatitis
Enrollment:
916 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M18-891
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

- 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 (within 6 months prior to Baseline) of inadequate response to
topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
systemic treatment for AD or for whom topical treatments are otherwise medically
inadvisable due to side effects or safety risks

Exclusion Criteria:

- Prior exposure to any Janus kinase (JAK) inhibitor

- Unable or unwilling to discontinue current 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

Edmonton - T5K 2V4

Edmonton - T6G 1C3

Vancouver - V5Z 4E8

Vancouver - V6H 4E1

St. John's - A1E 1V4

Barrie - L4M 7G1

Etobicoke - M8X 1Y9

Guelph - N1L 0B7

London - N6A 3H7

Mississauga - L5H 1G9

Newmarket - L3Y 5G8

Niagara Falls - L2H 1H5

Sudbury - P3E 5M4

Toronto - M2M 4J5

Saskatoon - S7K 0H6