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:
Active, not recruiting
Conditions:
Atopic Dermatitis
Enrollment:
912 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 ≥ 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 and subject meets Hanifin and Rajka criteria

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

- 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 1X3
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 - P3C 1X8
Toronto - M2M 4J5
Saskatoon - S7K 0H6