Evidence map›Paper›PMID 37962000›Full record

Trial reportClinical and translational medicine2023

A randomized, double-blind phase 1b study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of the NLRP3 inhibitor selnoflast in patients with moderate to severe active ulcerative colitis.

Barbara Klughammer, Luca Piali, Alexandra Nica, Sandra Nagel, Lorna Bailey, Christoph Jochum, Stanislav Ignatenko, Angela Bläuer, Sabrina Danilin, Pratiksha Gulati and 6 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
14.7field-weighted citation impact, top 1% 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

35 citing papers in PubMed, 47 citations in OpenAlex.

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  13. Toward targeting of inflammasome signaling in venous thrombosis.Journal of thrombosis and haemostasis : JTH · 2025
    Review
  14. Inflammasome targeting for periodontitis prevention is sex dependent.Proceedings of the National Academy of Sciences of the United States of America · 2025
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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

16 authors at 5 institutions in 4 countries.

Barbara KlughammerF. Hoffmann-La Roche AG, Basel, Switzerland.ORCID 0009-0008-4506-7264
Luca PialiF. Hoffmann-La Roche AG, Basel, Switzerland.
Alexandra NicaF. Hoffmann-La Roche AG, Basel, Switzerland.
Sandra NagelF. Hoffmann-La Roche AG, Basel, Switzerland.
Lorna BaileyRoche Products Limited, Welwyn Garden City, UK.
Christoph JochumCharité - Universitätsmedizin Berlin, Berlin, Germany.
Stanislav IgnatenkoCharité Research Organisation GmbH, Berlin, Germany.
Angela BläuerF. Hoffmann-La Roche AG, Basel, Switzerland.
Sabrina DanilinF. Hoffmann-La Roche AG, Basel, Switzerland.
Pratiksha GulatiF. Hoffmann-La Roche AG, Basel, Switzerland.
Joanne HaywardA4P Bio, Sandwich, UK.
Petar ScepanovicF. Hoffmann-La Roche AG, Basel, Switzerland.
Jitao David ZhangF. Hoffmann-La Roche AG, Basel, Switzerland.ORCID 0000-0002-3085-0909
Satish BhosaleIQVIA RDS (India) Pvt Ltd, Thane, India.
Chui Fung ChongF. Hoffmann-La Roche AG, Basel, Switzerland.
Andreas ChristF. Hoffmann-La Roche AG, Basel, Switzerland.
Roche (Switzerland) · CHCharité - Universitätsmedizin Berlin · DEIQVIA (India) · INPfizer (United Kingdom) · GBRoche (United Kingdom) · GB

Funding

F. Hoffmann-La Roche
6 · The paper itself

Abstract

backgroundThe NLRP3 inflammasome drives release of pro-inflammatory cytokines including interleukin (IL)-1β and IL-18 and is a potential target for ulcerative colitis (UC). Selnoflast (RO7486967) is an orally active, potent, selective and reversible small molecule NLRP3 inhibitor. We conducted a randomized, placebo-controlled Phase 1b study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of selnoflast.

methodsNineteen adults with previous diagnosis of UC and current active moderate to severe disease were randomized 2:1 to selnoflast or placebo for 7 days. A dose of 450 mg QD (once daily) was selected to achieve 90% IL-1β inhibition in plasma and colon tissue. Consecutive blood, sigmoid colon biopsies and stool samples were analyzed for a variety of PD markers. Safety and PK were also evaluated.

resultsSelnoflast was well-tolerated. Plasma concentrations increased rapidly after oral administration, reaching T

conclusionsSelnoflast was safe and well-tolerated. Selnoflast 450 mg QD achieved plasma and tissue exposure predicted to maintain IL-1β IC

trial registrationISRCTN16847938.

Indexed as

Colitis, UlcerativeAdultBiomarkersCytokinesHumansInflammasomesInterleukin-18NLR Family, Pyrin Domain-Containing 3 ProteinBiomarkersCytokinesInflammasomesInterleukin-18NLR Family, Pyrin Domain-Containing 3 Proteinbiomarkerinflammatory bowel diseaseinterleukin-1βNLRP3 inflammasomeNLRP3 inhibitorpharmacokineticsphase 1bsafetyulcerative colitis

Identifiers

PMID37962000
PMCPMC10644327
OpenAlexW4388673555

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.