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Clinical Trials

Date: 2017-12-20

Type of information: Interim results

phase: 2b

Announcement: interim 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 moderate to severe chronic plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

Disease: psoriatic arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country:

Trial details:

  • BE ACTIVE is a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of bimekizumab compared with placebo in adult patients with PsA. The study included a 12-week double-blind treatment period, after which patients continued to a 36-week dose-blind treatment period. The total duration of treatment is 48 weeks. The study included 206 patients with PsA, defined as having symptoms for at least six months prior to  study screening, three or more tender and swollen joint counts ? 3 at baseline. Subjects also had to have active psoriatic lesions or a documented history of psoriasis.
  • Patients were randomized into five dose regimens to receive either placebo or bimekizumab every four weeks subcutaneously for 12 weeks. They were then re-randomized to a dose-blind bimekizumab treatment group for 36 weeks. Patients are given the option to enter an extension study at week 48.
  • The primary efficacy variable evaluated in the Phase 2b BE ACTIVE study in patients with PsA was the percentage of patients who achieved at least 50% disease improvement at week 12, as measured by the ACR50 response. An ACR response is a standard measure of at least a 50% improvement in the number of tender and swollen joints and a 50% improvement in at least three of the following: the patient’s global assessment of disease status; the patient’s global assessment of pain; the physician’s global assessment of disease status; health assessment questionnaire disability index; serum C-reactive protein levels.
  • The secondary efficacy variables assessed at week 12 in BE ACTIVE include ACR20 and ACR70, a 20% and 70% improvement, respectively, in the American College of Rheumatology criteria; PASI90 and PASI75, a 90% and 75% improvement, respectively, in the Psoriasis Area and Severity Index. Safety variables include incidence of adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs and change from baseline in clinical laboratory variables.

Latest news:

  • • On December 20, 2017, UCB  announced that the Phase 2b BE ACTIVE study met the primary objective of establishing dose response for bimekizumab with statistical significance. The study also demonstrated efficacy in psoriatic arthritis (PsA) signs and symptoms, as well as skin clearance measured by the PASI90 response, compared to placebo at Week 12. The BE ACTIVE data build on the positive clinical results reported with bimekizumab in both psoriasis and ankylosing spondylitis. In the Phase 2b psoriasis study of moderate-to-severe patients, the dual neutralization of IL-17A and IL-17F with bimekizumab resulted in up to 60% of patients achieving complete skin clearance (PASI100) at week 12. A Phase 2b study of bimekizumab in ankylosing spondylitis also achieved the primary endpoint (ASAS40), with up to 47% of patients who received bimekizumab achieving at least 40% improvement in AS symptoms, versus 13% of patients on placebo, at week 12.iii PsA and AS are both forms of spondyloarthritis, a family of pathophysiologically and clinically related rheumatic diseases that typically involve the axial skeleton as well as peripheral joints, and are clearly distinct from rheumatoid arthritis.
  • BE ACTIVE investigated the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of bimekizumab compared with placebo in adult patients with active PsA. Bimekizumab achieved the primary and secondary clinical response thresholds for a significantly greater number of patients than placebo across multiple doses. Additionally, bimekizumab was generally well tolerated and no new safety signals were observed. The common cold (nasopharyngitis) was the most frequently reported adverse event compared to placebo. The BE ACTIVE study will continue for 36 weeks in a dose-blind manner to evaluate maintenance of efficacy and safety.

Is general: Yes