NCT02925117

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

Brief summary

This is an 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled multicenter study to evaluate the safety and efficacy of an active drug in adult subjects with moderate to severe atopic dermatitis. In Period 1, subjects will be randomized in a 1:1:1:1 ratio to one of four treatment groups.

Interventional study

Status:
Completed
Conditions:
Atopic Dermatitis
Enrollment:
167 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-048
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion Criteria:

- Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the
Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.

- Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index
(EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment
(IGA) score ≥ 3 at the Baseline visit.

- Documented history (within 1 year prior to the screening visit) of inadequate response
to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors
(TCI), or for whom topical treatments are otherwise medically inadvisable (e.g.,
because of important side effects or safety risks).

- Twice daily use of an additive-free, bland emollient for at least 7 days prior to
Baseline.

Exclusion Criteria:

- Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but
not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).

- Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI),
prescription moisturizers or moisturizers containing additives such as ceramide,
hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.

- Prior exposure to dupilumab or exposure to systemic therapies for AD including
corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4
(PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.

- Prior exposure to any investigational systemic treatment within 30 days or 5
half-lives (whichever is longer) of the Baseline visit or is currently enrolled in
another clinical study.

All the cities where the clinical studies are located

Calgary - T3A 2N1
Surrey - V3R 6A7
Surrey - V3V 0C6
Ajax - L1S 7K8
Markham - L3P 1X2
Ottawa - K2C 3N2
Waterloo - N2J 1C4

Alberta

British Columbia

More information about this study

clinicaltrials.gov