Evidence map›Paper›PMID 27572942›Full record

Trial reportDigestive diseases and sciences2016

Ameliorating Active Ulcerative Colitis via an Orally Available Toll-Like Receptor-9 Modifier: A Prospective Open-Label, Multicenter Phase II Trial.

Iris Dotan, Etgar Levy-Nissenbaum, Yehuda Chowers, Alexander Fich, Eran Israeli, Tomer Adar, Shimon Shteingart, Hermona Soreq, Eran Goldin

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Advancing therapeutic frontiers: a pipeline of novel drugs for UC management.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026
    Review
  2. Review
  3. Intestinal serotonergic system is modulated by Toll-like receptor 9.Journal of physiology and biochemistry · 2022
    Article
  4. Review
  5. Emerging therapeutic options in inflammatory bowel disease.World journal of gastroenterology · 2021
    Review
  6. Review
  7. Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Iris DotanDepartment of Gastroenterology and Liver Diseases, IBD Center, Tel Aviv Sourasky Medical Center and the Sackler Faculty of Medicine, Tel Aviv, Israel. irisd@tlvmc.gov.il.
Etgar Levy-NissenbaumBioLineRx Ltd., Modi'in, Israel.
Yehuda ChowersDepartment of Gastroenterology, Rambam Health Care Campus, Bat Galim, Haifa, Israel.
Alexander FichDepartment of Gastroenterology, Soroka Medical Center, Beer Sheba, Israel.
Eran IsraeliIBD Unit, Institute of Gastroenterology and Liver Diseases, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Tomer AdarDigestive Diseases Institute, Shaare Zedek Medical Center Affiliated with The Hebrew University, Jerusalem, Israel.
Shimon ShteingartDigestive Diseases Institute, Shaare Zedek Medical Center Affiliated with The Hebrew University, Jerusalem, Israel.
Hermona SoreqDepartment of Biological Chemistry, The Hebrew University of Jerusalem, Jerusalem, Israel.
Eran GoldinDigestive Diseases Institute, Shaare Zedek Medical Center Affiliated with The Hebrew University, Jerusalem, Israel.
Shaare Zedek Medical Center · ILHadassah Medical Center · ILHebrew University of Jerusalem · ILRambam Health Care Campus · ILSoroka Medical Center · ILTel Aviv Sourasky Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment of active ulcerative colitis is associated with incomplete efficacy, adverse events, and loss of response. Toll-like receptor-9 mediates innate and adaptive immune response toward intestinal microorganisms. The oral synthetic oligonucleotide toll-like receptor-9 modulator has demonstrated anti-inflammatory properties in colitis murine models and a satisfactory safety profile in humans.

aimTo evaluate the efficacy and safety of BL-7040 (a Toll-like receptor-9 modulator) in patients with moderately active ulcerative colitis.

methodsModerately active ulcerative colitis patients were included in this multicenter, open-label phase IIa trial. Concomitant mesalamine and steroids at a stable dose were allowed. Clinical outcome was evaluated using the Mayo score, histology, and mucosal cytokine levels. Side effects were registered.

resultsSixteen out of 22 patients completed a 5-week treatment course and 2-week follow-up. Six patients discontinued the study, three of them due to adverse events. Clinical remission was observed in two patients (12.5 %), and clinical response as well as mucosal healing were achieved in half (50 %) of the patients, while all others remained stable. Furthermore, mucosal neutrophil (p = 0.002) and mucosal interleukin-6 levels (p = 0.046) were significantly reduced in responders compared to non-responders. Toll-like receptor-9 was well tolerated with only one unrelated to study drug serious adverse event (hemoglobin decrease) and 29 mild-to-moderate adverse events.

conclusionsOral administration of the Toll-like receptor-9 agonist BL-7040 appeared efficacious, safe and well tolerated in patients with moderately active ulcerative colitis.

Indexed as

Administration, OralAdultColitis, UlcerativeColonFemaleHumansInterleukin-10Interleukin-12Interleukin-1betaInterleukin-6Interleukin-8Intestinal MucosaMaleMiddle AgedNeutrophilsOligodeoxyribonucleotidesCXCL8 protein, humanEN101IL10 protein, humanIL1B protein, humanIL6 protein, humanInterleukin-10Interleukin-12Interleukin-1betaInterleukin-6Interleukin-8OligodeoxyribonucleotidesTNF protein, humanToll-Like Receptor 9Tumor Necrosis Factor-alphaOral treatmentPro-inflammatory cytokinesSynthetic oligonucleotideToll-like receptor-9Ulcerative colitis

Identifiers

PMID27572942
OpenAlexW2508208441

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.