ArticleJournal of gastroenterology and hepatology2021
Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease.
Article in Journal of gastroenterology and hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02039063 (A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- An overview of the role of chemokine CX3CL1 (Fractalkine) and CX3C chemokine receptor 1 in systemic sclerosis.Immunity, inflammation and disease · 2024Pooled it
- A placebo-controlled Phase 2 trial of E6011, anti-human fractalkine monoclonal antibody, in primary biliary cholangitis.Journal of translational autoimmunity · 2025Article
- Estrogen receptor β activation alleviates inflammatory bowel disease by suppressing NLRP3-dependent IL-1β production in macrophages via downregulation of intracellular calcium level.Journal of advanced research · 2025Article
- Article
- Expression of IL-7RαPediatric gastroenterology, hepatology & nutrition · 2024Article
- Fractalkine Signalling (CXJournal of clinical medicine · 2023Review
- Prevalence and Risk Factors of Anemia in Inflammatory Bowel Diseases: A Case-Control Study.Cureus · 2023Article
- Mechanism-based target therapy in primary biliary cholangitis: opportunities before liver cirrhosis?Frontiers in immunology · 2023Review
- Analysis of the interferon-γ-induced secretome of intestinal endothelial cells: putative impact on epithelial barrier dysfunction in IBD.Frontiers in cell and developmental biology · 2023Article
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
- Potential significance of CX3CR1 dynamics in stress resilience against neuronal disorders.Neural regeneration research · 2022Review
- Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease.Journal of gastroenterology and hepatology · 2021Article
- New Insights Regarding Diagnosis and Medication for Schizophrenia Based on Neuronal Synapse-Microglia Interaction.Journal of personalized medicine · 2021Review
- An Early Phase 2 Double-Blind, Placebo-Controlled Study of E6011, a Novel Anti-Fractalkine Antibody, in Patients with Crohn's Disease.Inflammatory intestinal diseasesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
BACKGROUND AND
aimE6011 is a humanized monoclonal antibody targeting fractalkine (FKN), a CX3C chemokine, which regulates leukocyte trafficking during inflammation. We evaluated the safety and pharmacokinetic profile of E6011 in patients with Crohn's disease (CD) and also performed preliminary pharmacodynamic (PD) and efficacy assessments.
methodsThis study included a 12-week multiple ascending dose (MAD) phase (2, 5, 10, and 15 mg/kg intravenously every 2 weeks, n = 6, 8, 7, and 7, respectively) and a 40-week Extension phase (n = 12) at the same dose as the MAD phase. Serum E6011, serum total FKN (free soluble FKN and E6011-FKN complex) as a PD marker and CD activity index were evaluated. The primary outcome was safety assessment in the MAD phase.
resultsTwenty-seven (96%) of 28 patients had previously been treated with anti-tumor necrosis factor α agents. During the MAD phase, adverse events (AEs) occurred in 18 (64%). The most common AE was nasopharyngitis (five patients, 18%). No severe AEs occurred. Serious AEs occurred in three patients, progression of CD in two, and anemia in one. Serum E6011 concentrations increased dose-dependently after infusion and reached a plateau around 4-6 weeks. Serum total FKN rose simultaneously. Five (18%) patients developed anti-E6011 antibodies during the study. Overall, clinical response and clinical remission were observed at Week 12 in 40% (10/25) and 16% (4/25) of active CD patients, respectively.
conclusionE6011 was well-tolerated and might be effective in CD patients. These findings need to be clarified in a randomized controlled study.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.