A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

AbbVie

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: risankizumab; Drug: Fumaderm

Study type: Interventional

Funder types: Industry

Identifiers

NCT03255382

M16-178

2016-003718-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

Full description

The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all participants who received at least one dose of study drug. No participants were excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued after randomization prior to receiving any study drug and were thus not included in the safety set.

Enrollment: 120 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant
• Participant has stable moderate to severe plaque psoriasis (body surface area [BSA] >10, Psoriasis Area and Severity Index [PASI] >10, and Dermatology Quality of Life Index [DLQI] >10) with or without psoriatic arthritis at Baseline
• Must be naïve to and candidate for systemic therapy, as assessed by the investigator
• Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment

Exclusion criteria

• Participants with non-plaque forms of psoriasis
• Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy
• Active systemic infection during the last 2 weeks (exception: common cold) prior to screening.
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
• Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Risankizumab

Experimental group

Description:

Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

Treatment:

Drug: risankizumab

Fumaderm

Active Comparator group

Description:

Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows.

Treatment:

Drug: Fumaderm