Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)

UCB

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Other: Placebo; Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02905006

2016-001891-31 (EudraCT Number)

PS0010

Details and patient eligibility

About

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has provided informed consent
• Chronic plaque psoriasis for at least 6 months prior to Screening
• PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
• Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug
• Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication

Exclusion criteria

• Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
• Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
• Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
• Subject taking prohibited psoriatic medications
• Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
• Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
• Subject has any current sign or symptom that may indicate an active infection (except for common cold)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Bimekizumab dosing regimen 1

Experimental group

Treatment:

Other: Placebo

Drug: Bimekizumab

Bimekizumab dosing regimen 2

Experimental group

Treatment:

Other: Placebo

Drug: Bimekizumab

Bimekizumab dosing regimen 3

Experimental group

Treatment:

Other: Placebo

Drug: Bimekizumab

Bimekizumab dosing regimen 4

Experimental group

Treatment:

Other: Placebo

Drug: Bimekizumab

Bimekizumab dosing regimen 5

Experimental group

Treatment:

Drug: Bimekizumab