Abstract | BACKGROUND AND AIMS: METHODS: This was a phase IIa, multicentre, randomised, double-blind, parallel group, placebo-controlled study comparing amiselimod 0.4 mg with placebo over a 14-Week treatment period. The primary endpoint of the study was the proportion of participants with clinical response ( Crohn's Disease activity Index [CDAI] 100) from baseline at Week 12. RESULTS: A total of 180 patients were screened and 78 were randomised [40 to amiselimod 0.4 mg and 38 to placebo]. There was no significant difference in the proportion of patients achieving CDAI 100 at Week 12 on amiselimod 0.4 mg and on placebo [48.7% vs. 54.1%, respectively] (odds ratio [OR] [95% confidence interval]: 0.79 [0.31, 1.98]). The results from the secondary endpoint analyses supported the results of the primary endpoint analysis. Treatment with amiselimod 0.4 mg was generally well tolerated, with 71.8% of participants completing the 14-week treatment period. Seven participants had serious adverse events and four discontinued treatment in the amiselimod group. CONCLUSIONS:
Amiselimod 0.4 mg for 12 weeks was not superior to placebo for the induction of clinical response [CDAI 100] in Crohn's disease. Treatment with amiselimod 0.4 mg was generally well tolerated and no new safety concerns related to amiselimod were reported in this study.
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Authors | Geert D'Haens, Silvio Danese, Martin Davies, Mamoru Watanabe, Toshifumi Hibi |
Journal | Journal of Crohn's & colitis
(J Crohns Colitis)
Vol. 16
Issue 5
Pg. 746-756
(Jun 24 2022)
ISSN: 1876-4479 [Electronic] England |
PMID | 34758080
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: [email protected]. |
Chemical References |
- Propanolamines
- amiselimod
- Fingolimod Hydrochloride
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Topics |
- Crohn Disease
(therapy)
- Double-Blind Method
- Fingolimod Hydrochloride
(therapeutic use)
- Humans
- Propanolamines
(adverse effects)
- Treatment Outcome
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