Trial reportJournal of Crohn's & colitis2016
Clinical Effects of a Topically Applied Toll-like Receptor 9 Agonist in Active Moderate-to-Severe Ulcerative Colitis.
Trial report in Journal of Crohn's & colitis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.
- Management of paediatric ulcerative colitis, part 1: Ambulatory care-An updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- The TLR9 Agonist Cobitolimod Induces IL10-Producing Wound Healing Macrophages and Regulatory T Cells in Ulcerative Colitis.Journal of Crohn's & colitis · 2020Trial
- Dual roles of complement in ulcerative colitis: insights from clinical studies and animal research.European journal of medical research · 2025Review
- TLR9: A Double-Dealing Toll-Like Receptor.ImmunoTargets and therapy · 2025Review
- Interactions between toll-like receptors signaling pathway and gut microbiota in host homeostasis.Immunity, inflammation and disease · 2024Review
- Engaging natural antibody responses for the treatment of inflammatory bowel disease via phosphorylcholine-presenting nanofibres.Nature biomedical engineering · 2024Article
- Horizon scanning: new and future therapies in the management of inflammatory bowel disease.eGastroenterology · 2023Review
- Review
- Review
- Exploring the Pipeline of Novel Therapies for Inflammatory Bowel Disease; State of the Art Review.Biomedicines · 2023Review
- Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials.Clinical and experimental gastroenterology · 2023Review
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
- Cell-Free DNA in the Pathogenesis and Therapy of Non-Infectious Inflammations and Tumors.Biomedicines · 2022Review
- The Role of the Human Gut Microbiome in Inflammatory Bowel Disease and Radiation Enteropathy.Microorganisms · 2022Review
- Innovative, complementary and alternative therapy in inflammatory bowel diseases: A broad 2020s update.Frontiers in gastroenterology (Lausanne, Switzerland) · 2022Review
- New targets in inflammatory bowel disease therapy: 2021.Current opinion in gastroenterology · 2021Review
- The dark side of the gut: Virome-host interactions in intestinal homeostasis and disease.The Journal of experimental medicine · 2021Review
- Microbiome characterization and re-design by biologic agents for inflammatory bowel disease insights.Bioprocess and biosystems engineering · 2021Review
- The role of mucosal barriers in human gut health.Archives of pharmacal research · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 13 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsToll-like receptors [TLRs] are potential drug targets for immunomodulation. We determined the safety and efficacy of the TLR-9 agonist DNA-based immunomodulatory sequence 0150 [DIMS0150] in ulcerative colitis [UC] patients refractory to standard therapy.
methodsIn this randomized, double-blind, placebo-controlled trial, 131 patients with moderate-to-severe active UC were randomized to receive two single doses of the oligonucleotide DIMS0150 [30 mg] or placebo administered topically during lower GI endoscopy at baseline and Week 4. The primary endpoint was clinical remission, defined as Clinical Activity Index [CAI] ≤4, at Week 12. Secondary endpoints included mucosal healing and symptomatic remission of key patient-reported outcomes [absence of blood in stool and weekly stool frequency <35].
resultsThere was no statistical significant difference between the groups in the induction of clinical remission at Week 12, with 44.4% in the DIMS0150 group vs. 46.5% in the placebo group. However, the proportion of patients who achieved symptomatic remission was 32.1% in the DIMS0150 group vs. 14.0% in the placebo group at Week 4 [p = 0.020], and 44.4% vs. 27.9% at Week 8 [p = 0.061]. More patients on DIMS0150 compared with those on placebo had mucosal healing [34.6% vs. 18.6%; p = 0.09] and histological improvement regarding the Geboes score [30.9% vs. 9.3%; p = 0.0073] at Week 4. Significantly more patients on DIMS0150 were in clinical remission with mucosal healing at Week 4: 21% vs. 4.7% in the placebo group [p = 0.02]. DIMS0150 was well tolerated, and no safety signals compared with placebo were evident.
conclusionsTherapy with the topically applied TLR-9 agonist DIMS0150 is a promising and well-tolerated novel therapeutic option for treatment-refractory, chronic active UC patients, warranting further clinical trials.
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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.