A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 2)

UCB

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Other: Placebo; Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03010527

PS0011

2016-001892-57 (EudraCT Number)

Details and patient eligibility

About

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has provided informed consent
• Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
• Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

Exclusion criteria

• Subject has previously participated in this study.
• Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
• Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
• Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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217 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.

Treatment:

Other: Placebo

Bimekizumab dosing regimen 1

Experimental group

Description:

Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.

Treatment:

Drug: Bimekizumab

Bimekizumab dosing regimen 2

Experimental group

Description:

Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.

Treatment:

Drug: Bimekizumab

Bimekizumab dosing regimen 3

Experimental group

Description:

Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.

Treatment:

Drug: Bimekizumab