Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study

医学 安慰剂 临床终点 内科学 人口 临床试验 胃肠病学 钙蛋白酶 临床研究阶段 不利影响 免疫学 病理 疾病 替代医学 炎症性肠病 环境卫生
作者
Walter Reinisch,Julían Panés,Sunil Khurana,Gábor Tóth,Fei Hua,Gail M. Comer,Michelle Hinz,Karen Page,Margot O’Toole,Tara McDonnell Moorehead,Huachen Zhu,Yanhui Sun,Fabio Cataldi
出处
期刊:Gut [BMJ]
卷期号:64 (6): 894-900 被引量:144
标识
DOI:10.1136/gutjnl-2014-308337
摘要

Objective

Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC.

Design

In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and <10) were randomised to anrukinzumab 200, 400 or 600 mg or placebo. Patients received five intravenous administrations over 14 weeks. The primary endpoint was fold change from baseline in faecal calprotectin (FC) at Week 14. Secondary endpoints included safety, pharmacokinetics and IL-13 levels.

Results

The modified intention-to-treat population included 84 patients (21 patients/arm). Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo. The study had a high dropout rate, in part, related to lack of efficacy. The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score, clinical response, clinical remission and proportion of subjects with mucosal healing. An increase in serum total IL-13 (free and bound to anrukinzumab) was observed for all anrukinzumab groups but not with placebo. This suggests significant binding of anrukinzumab to IL-13. The safety profile was not different between the anrukinzumab and placebo groups.

Conclusions

A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13.

Trial registration number

ClinicalTrials.gov number NCT01284062.
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