NCT03706040

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

Brief summary

The purpose of this study is to assess the safety and efficacy of an active drug for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects.

Interventional study

Status:
Active, not recruiting
Conditions:
Dermatitis
Enrollment:
172 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-813
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

Would you like to know more about this trial?

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Eligibility criteria

Participant attributes:
Male and Female

Age:

12 Years and older.

Inclusion Criteria:

- adults who are ≥ 18 years old and, where locally permissible and approved, adolescent
subjects who are at least 12 years old

- a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to
Baseline and subject meets Hanifin and Rajka criteria

- moderate to severe AD at the Baseline Visit

- history of inadequate response to previous topical corticosteroid and/or topical
calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

- prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor

- concurrent treatment with systemic therapy for AD (biologic or non-biologic) or
topical and/or phototherapy treatments

All the cities where the clinical studies are located

Calgary - T2G 1B1

Edmonton - T6G 2B7

London - N6H 5L5

Markham - L3P 1X2

Sudbury - P3E 5M4

St-Jerome - J7Z 7E2