Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026
Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMirikizumab, a p19-directed anti-interleukin-23 antibody, demonstrated efficacy in patients with moderately-to-severely active ulcerative colitis in the global phase 3 LUCENT-1 induction (NCT03518086) and LUCENT-2 maintenance (NCT03524092) trials.
objectiveThe aim was to conduct a pre-specified Chinese subpopulation analysis of LUCENT-1 and LUCENT-2.
methodsIn LUCENT-1, patients were randomized 3:1 to mirikizumab 300 mg or placebo intravenously every 4 weeks (Q4W) for 12 weeks. In LUCENT-2, patients with a clinical response to mirikizumab at week 12 of LUCENT-1 were re-randomized 2:1 to mirikizumab 200 mg or placebo via subcutaneous injection Q4W for 40 weeks. The primary endpoint in both trials was clinical remission at study end, defined as a Mayo stool frequency subscore of 0, or 1 with a ≥ 1-point decrease from baseline, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1 (excluding friability).
resultsAmong 183 Chinese patients included in the LUCENT-1 induction trial, clinical remission rates at week 12 were higher with mirikizumab 300 mg (n = 140) versus placebo (n = 43) (18.6% vs. 7.0%; common risk difference 11.5%). Among 80 patients who responded to mirikizumab and underwent randomization again in the LUCENT-2 maintenance trial, clinical remission rates at week 40 were higher with mirikizumab 200 mg (n = 56) versus placebo (n = 24) (50.0% vs. 12.5%; common risk difference 40.4%). During induction and maintenance, the incidence of adverse events was comparable between the mirikizumab and placebo groups.
conclusionsMirikizumab was effective and well tolerated in the subpopulation of Chinese patients with moderately-to-severely active ulcerative colitis, consistent with the overall trial population. TRIAL REGISTRATIONS: Clinicaltrials.gov (NCT03518086 and NCT03524092).
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