Clinical Trials

Date: 2017-07-21

Type of information: Results

phase: 2b

Announcement: results

Company: UCB (Belgium)

Product: bimekizumab

Action mechanism:

monoclonal antibody. Bimekizumab is a monoclonal IgG1 antibody that neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. They are both co-expressed at sites of inflammation and have overlapping pro-inflammatory functions. Both IL-17A and IL-17F can independently cooperate with other inflammatory mediators to drive chronic inflammation and tissue destruction.
Previous early phase clinical studies in psoriasis and psoriatic arthritis have suggested that dual neutralization of both IL-17A and IL-17F with bimekizumab may provide a new targeting approach for the treatment of immune-mediated inflammatory diseases.
UCB is also studying bimekizumab in other disease areas, including psoriatic arthritis and ankylosing spondylitis.

Disease: moderate to severe chronic plaque psoriasis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country:

Trial details:

BE ABLE is a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of bimekizumab compared with placebo in adult patients with moderate to severe chronic plaque psoriasis. The study included a 12-week treatment period, after which eligible patients could enroll in an extension study. For those not enrolling in the extension study, a safety follow-up visit was conducted 20 weeks after the last dose of study medication.
The study included 250 patients with chronic plaque psoriasis with an affected body surface area of at least 10% and PASI of at least 12. Patients were randomized into six dosing regimens to receive either placebo or bimekizumab every four weeks subcutaneously. Randomization was balanced across treatment groups.
The secondary efficacy variables assessed in BE ABLE were Investigator’s Global Assessment of response (IGA) defined as clear or almost clear skin with at least 2 category improvement from baseline at week 8 and at week 12, PASI90 response at week 8, PASI75 response at week 12, and PASI100 response at week 12.

Latest news:

• On July 21, 2017, UCB announced positive results from BE ABLE, a Phase 2b study to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of bimekizumab compared with placebo in adult patients with moderate to severe chronic plaque psoriasis. The study met the primary objective of establishing dose response for bimekizumab, and demonstrated significant efficacy compared to placebo. The primary efficacy variable evaluated in the Phase 2b BE ABLE study was the percentage of patients who achieved at least 90% disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 90) at week 12. Bimekizumab achieved this clinical response threshold for a significantly greater number of patients than placebo across multiple doses.
Additionally, bimekizumab showed a favourable safety profile with no new safety signals observed. The most common adverse events observed were runny nose (nasopharyngitis) and common cold (upper-respiratory tract infection).
UCB plans to present and publish the full results of BE ABLE in early 2018. The company is also preparing a Phase 3 psoriasis clinical development program.