NCT03478787

An Active Drug Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis

Brief summary

The main objective of this study is to evaluate the efficacy and safety of an active drug compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Interventional study

Status:
Completed
Conditions:
Psoriasis
Enrollment:
327 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-766
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least
6 months before the Baseline Visit

- Subject has stable moderate to severe chronic plaque psoriasis with or without
psoriatic arthritis

- Subject must be a candidate for systemic therapy as assessed by the investigator;

- Subject must be an acceptable candidate to receive secukinumab according to the local
label for this compound.

Exclusion Criteria:

- History of erythrodermic psoriasis, generalized or localized pustular psoriasis,
medication-induced or medication-exacerbated psoriasis, or new onset guttate
psoriasis; or active skin disease other than psoriasis that could interfere with the
assessment of psoriasis;

- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or
active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein
derivative (PPD) test result may participate in the study if further work up
(according to local practice/guidelines) establishes conclusively that the subject has
no evidence of active tuberculosis. If presence of latent tuberculosis is established,
then treatment must have been initiated and maintained according to local country
guidelines.

- Active systemic infection during the last 2 weeks prior to Baseline Visit (exception:
common cold)

- History of any documented active or suspected malignancy or history of any malignancy
within the last 5 years except for successfully treated non-melanoma skin cancer
(NMSC) or localized carcinoma in situ of the cervix

- Previous exposure to risankizumab

- Previous exposure to secukinumab

All the cities where the clinical studies are located

Calgary - T3E 0B2
Surrey - V3V 0C6
Halifax - B3H 1Z2
Hamilton - L8N 1Y2
Quebec - G1V 4X7
Saint-Jerome - J7Z 7E2
Fredericton - E3B 1G9

Alberta

British Columbia

New Brunswick

Nova Scotia

Ontario