Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

AbbVie

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: risankizumab; Drug: secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03478787

M16-766

2017-004932-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 327 patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

327 participants in 2 patient groups

Risankizumab

Experimental group

Description:

Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).

Treatment:

Drug: risankizumab

Secukinumab

Active Comparator group

Description:

Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.

Treatment:

Drug: secukinumab