Date: 2016-05-24
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the Digestive Disease Week (DDW) 2016 in San Diego
Company: Abbvie (USA - IL) Boehringer Ingelheim (Germany)
Product: BI 655066/ABBV-066 (risankizumab)
Action
mechanism:
- monoclonal antibody. Risankizumab selectively blocks IL-23, a key protein involved in inflammatory processes that has been linked to a number of chronic immune-mediated diseases. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. The therapeutic potential of risankizumab is being evaluated in immunological disorders, including Crohn’s disease, psoriasis, and psoriatic arthritis.
Disease: Crohn disease
Therapeutic
area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Belgium, Canada, France, Germany, Ireland, Korea, Republic of, Netherlands, Poland, Spain, UK, USA
Trial
details:
- This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease. (NCT02031276)
Latest
news:
- • On May 24, 2016, Boehringer Ingelheim announced the presentation of a proof-of-concept, Phase II, randomized, placebo-controlled study in Crohn’s disease with risankizumab (formerly BI 655066) at the Digestive Disease Week (DDW) conference in San Diego, USA. Risankizumab was shown to be more effective than placebo in patients with moderately-to-severely active Crohn’s disease. These interim results are the first to be reported in this indication with risankizumab, which selectively blocks IL-23 through the specific targeting of the IL-23p19 subunit. After 12 weeks, 24% and 37% of patients achieved clinical remission (no symptoms or very mild symptoms of disease) with 200 mg and 600 mg risankizumab, respectively, compared with 15% of patients receiving placebo*1. Endoscopic remission (normalization of the lining of bowel as seen during an endoscopy) was achieved by 15% and 20% of patients receiving 200 mg and 600 mg risankizumab, respectively, compared with three percent of patients receiving placebo.
- Risankizumab also achieved higher rates of clinical response (defined by a Crohn's Disease Activity Index of <150 or a reduction from baseline of at least 100 points) than placebo with nearly twice as many patients achieving a clinical response with risankizumab (37% and 42% in the 200 mg and 600 mg groups, respectively) compared with the placebo group (21%) at Week 12.1 Risankizumab was well tolerated in this clinical trial, with numerically fewer severe or serious adverse events in risankizumab treated patients compared with placebo. Most frequently reported adverse events were gastrointestinal events (nausea, worsening of Crohn`s disease, abdominal pain, vomiting), arthralgia, anemia and headache.
Risankizumab also showed the following results at 12 weeks: Endoscopic response (>50% improvement in the lining of the bowel from before treatment started, as seen during an endoscopy) was achieved by 37% of patients receiving 600 mg risankizumab, compared with 13% of patients receiving placebo.
Deep remission (patients achieving clinical and endoscopic remission at the same time) was achieved by 12% of patients receiving 600 mg risankizumab, compared with none in the placebo group. The trial is ongoing and will evaluate patients up to 52 weeks.
Is
general: Yes
