Evidence map›Paper›PMID 41933275›Full record

Trial reportAlimentary pharmacology & therapeutics2026

Seladelpar Improved Itch, Itch-Related Sleep Disturbance and Measures of Fatigue in Patients With Primary Biliary Cholangitis and Pruritus in the Phase 3 RESPONSE Trial.

Cynthia Levy, David E J Jones, Marlyn J Mayo, Christopher L Bowlus, Kris V Kowdley, Gideon M Hirschfield, Jie Liu, Caroline Burk, Susheela Carroll, Daria B Crittenden and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04620733 (RESPONSE), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04620733 phase3completednot on this map

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

TypeinterventionalSponsorGilead SciencesRan2021 to 2023Enrolled193ConditionsPrimary Biliary CholangitisArmsSeladelpar 10 mg, Placebo, Seladelpar 5 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
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

11 authors.

Cynthia LevySchiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.
David E J JonesDepartment of Medical Sciences, NIHR Newcastle Biomedical Research Centre, Newcastle, UK.
Marlyn J MayoDivision of Digestive and Liver Diseases, University of Texas SW Medical Center, Dallas, Texas, USA.
Christopher L BowlusDivision of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, California, USA.
Kris V KowdleyLiver Institute Northwest, Seattle, WA, USA.
Gideon M HirschfieldThe Autoimmune and Rare Liver Disease Programme, Toronto General Hospital, Toronto, Ontario, Canada.
Jie LiuGilead Sciences, Inc., Foster City, California, USA.
Caroline BurkGilead Sciences, Inc., Foster City, California, USA.
Susheela CarrollGilead Sciences, Inc., Foster City, California, USA.
Daria B CrittendenGilead Sciences, Inc., Foster City, California, USA.
Andreas E KremerDepartment of Gastroenterology and Hepatology, University Hospital Zürich, University of Zürich, Zürich, Switzerland.ORCID 0000-0002-9263-948X

Funding

Gilead Sciences, Inc.
6 · The paper itself

Abstract

backgroundPruritus and fatigue impose a significant burden on patient quality of life in primary biliary cholangitis (PBC). In the Phase 3 RESPONSE trial (NCT04620733), seladelpar, a potent and selective PPARδ agonist, significantly improved markers of cholestasis and pruritus.

aimsHere, we provide additional details on the effects of seladelpar on pruritus and quality of life.

methodsIn RESPONSE, patients with PBC and an inadequate response or intolerance to ursodeoxycholic acid were randomised 2:1 to seladelpar 10 mg or placebo for 12 months. Changes in severity of pruritus by the numeric rating scale (NRS) and changes in 5-D Itch and PBC-40 in patients with moderate to severe itch (NRS ≥ 4), severe itch (NRS ≥ 7) and clinically significant itch (PBC-40 itch ≥ 7) at baseline were evaluated.

resultsIn patients with baseline NRS ≥ 4, mean NRS improved from the moderate to mild range with seladelpar, but not placebo. Bodily distribution of itch was reduced with seladelpar based on the 5-D itch distribution domain. Itch-related sleep disturbance was consistently improved with seladelpar across populations, and measures of fatigue were improved versus placebo in patients with severe itch at baseline. Patients without itching tended to remain free from itching with seladelpar, consistent with fewer adverse events of pruritus with seladelpar versus placebo.

conclusionIn addition to an established anticholestatic effect, seladelpar improved pruritus severity and distribution, itch-related sleep disturbance and measures of fatigue in patients with PBC and pruritus, indicating clinically relevant improvements in itch and other quality of life benefits.

Indexed as

FatigueLiver Cirrhosis, BiliaryPruritusSleep Wake DisordersAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeSeverity of Illness IndexTreatment Outcomecholestatic liver diseaseliveroutcomes researchprimary biliary cholangitis

Identifiers

PMID41933275
PMCPMC13251588

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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.