Evidence map›Paper›PMID 38291895›Full record

Trial reportRheumatology (Oxford, England)2025

A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's.

Göran Tornling, Charlotte Edenius, John D Pauling, Christopher P Denton, Anna Olsson, Jan Kowalski, Andrea Murray, Marina Anderson, Smita Bhat, Francesco Del Galdo and 9 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Article
  2. Review
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  5. Review
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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

19 authors.

Göran TornlingRespiratory Medicine Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Charlotte EdeniusGesynta Pharma AB, Stockholm, Sweden.
John D PaulingDepartment of Rheumatology, North Bristol NHS Trust, Bristol, UK.
Christopher P DentonCentre for Rheumatology, Royal Free Hospital and University College London, London, UK.ORCID 0000-0003-3975-8938
Anna OlssonGesynta Pharma AB, Stockholm, Sweden.
Jan KowalskiJK Biostatistics AB, Stockholm, Sweden.
Andrea MurrayCentre for Musculoskeletal Research, The University of Manchester, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.ORCID 0000-0001-9244-2882
Marina AndersonAintree University Hospital, Liverpool University Hospitals NHS Trust, Liverpool, UK.
Smita BhatNinewells Hospital and Medical School, Dundee, UK.
Francesco Del GaldoLeeds Institute of Rheumatology & Musculoskeletal Medicine, and NIHR Leeds Biomedical Research Centre, University of Leeds, Leeds, UK.ORCID 0000-0002-8528-2283
Frances HallCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Mariusz KorkoszCentrum Medyczne Pratia MCM Krakow, Krakow, Poland.
Dorota KrasowskaDepartment of Dermatology, Venereology and Pediatric Dermatology Medical University of Lublin, Poland.
Jacek OlasMałopolskie Centrum Kliniczne, Kraków, Poland.
Vanessa SmithDepartment of Internal Medicine, Ghent University, Ghent, Belgium.ORCID 0000-0001-6271-7945
Jacob M van LaarUniversity Medical Center Utrecht, Utrecht, The Netherlands.ORCID 0000-0001-5544-5785
Madelon C VonkDepartment of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.
Anna WojteczekEarly Phase Clinical Trials Centre, Medical University of Gdańsk, Gdańsk, Poland.
Ariane L HerrickCentre for Musculoskeletal Research, The University of Manchester, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.ORCID 0000-0003-4941-7926

Funding

Gesynta Pharma AB
6 · The paper itself

Abstract

objectiveOur objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), which decreases prostaglandin E2 (PGE2) and increases prostacyclin biosynthesis, improves RP.

methodsPatients with SSc and ≥7 RP attacks during the last screening week prior to a baseline visit were randomized to 4 weeks treatment with vipoglanstat 120 mg or placebo. A daily electronic diary captured RP attacks (duration and pain) and Raynaud's Condition Score, with change in RP attacks/week as the primary end point. Cold challenge assessments were performed at baseline and end of treatment. Exploratory end points included patients' and physicians' global impression of change, Assessment of Scleroderma-associated Raynaud's Phenomenon questionnaire, mPGES-1 activity, and urinary excretion of arachidonic acid metabolites.

resultsSixty-nine subjects received vipoglanstat (n = 33) or placebo (n = 36). The mean weekly number of RP attacks [baseline; vipoglanstat 14.4 (S.D. 6.7), placebo 18.2 (12.6)] decreased by 3.4 (95% CI -5.8; -1.0) and 4.2 (-6.5; -2.0) attacks per week (P = 0.628), respectively. All patient-reported outcomes improved, with no difference between the groups. The mean change in recovery of peripheral blood flow after the cold challenge did not differ between the study groups. Vipoglanstat fully inhibited mPGES-1, resulting in 57% reduction of PGE2 and 50% increase of prostacyclin metabolites in the urine. Vipoglanstat was safe and well tolerated.

conclusionAlthough vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP. Further development and evaluation of vipoglanstat will therefore be in other diseases where mPGES-1 plays a pathogenetic role.

trial registrationClinicalTrials.gov, https://www.clinicaltrials.gov, NCT0474420.

Indexed as

Prostaglandin-E SynthasesRaynaud DiseaseScleroderma, SystemicAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeProstaglandin-E Synthasesclinical trialmicrosomal prostaglandin E synthase-1Raynaud’s phenomenonsystemic sclerosisvipoglanstat

Identifiers

PMID38291895
PMCPMC11781579

What OpenQuestion holds

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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.