Evidence map›Paper›PMID 41405008›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

Nemolizumab in prurigo nodularis up to 100 weeks: OLYMPIA LTE interim analysis.

Franz J Legat, Shawn G Kwatra, Adam Reich, Serge Boulinguez, Athanasios Tsianakas, Maxwell Sauder, Sebastien Barbarot, Jacek C Szepietowski, Curdin Conrad, Andrew E Pink and 13 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03181503 phase2completednot on this map

A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)

TypeinterventionalSponsorGalderma R&DRan2017 to 2018Enrolled70ConditionsPrurigo NodularisArmsCD14152 Dose A, CD14152 placebo
NCT04204616 phase3active not recruitingnot on this map

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

TypeinterventionalSponsorGalderma R&DRan2021 to 2026Enrolled500ConditionsPrurigo NodularisArmsNemolizumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

23 authors.

Franz J LegatDepartment of Dermatology and Venereology, Medical University of Graz, Graz, Austria.ORCID https://orcid.org/0000-0002-7785-4739
Shawn G KwatraDepartment of Dermatology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Adam ReichDepartment of Dermatology, University of Rzeszów, Rzeszów, Poland.
Serge BoulinguezDepartment of Dermatology, Medical University of Toulouse, Toulouse, France.
Athanasios TsianakasDepartment of Dermatology, Fachklinik Bad Bentheim, Bad Bentheim, Germany.
Maxwell SauderProbity Medical Research, Waterloo, Ontario, Canada.ORCID https://orcid.org/0000-0002-5605-3844
Sebastien BarbarotDepartment of Dermatology, University Hospital, Nantes, France.ORCID https://orcid.org/0000-0002-6629-9100
Jacek C SzepietowskiDivision of Dermatology, Venereology and Clinical Immunology, Faculty of Medicine, Wrocław University of Science and Technology, Wrocław, Poland.
Curdin ConradDepartment of Dermatology, Lausanne University Hospital CHUV and University of Lausanne, Lausanne, Switzerland.ORCID https://orcid.org/0000-0002-2547-3440
Andrew E PinkSt John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Elke WeisshaarUniversity Hospital Heidelberg Occupational Dermatology, Heidelberg, Germany.
Laurent MiseryDepartment of Dermatology, University Hospital of Brest, Brest, France.ORCID https://orcid.org/0000-0001-8088-7059
Martin MetzInstitute of Allergology, Charité - Universitätsmedizin, Berlin, Germany.ORCID https://orcid.org/0000-0002-4070-9976
Vivian T LaquerFirst OC Dermatology Research, Fountain Valley, California, USA.
Raja K SivamaniIntegrative Skin Science and Research, Sacramento, California, USA.
Gil YosipovitchMiller School of Medicine, University of Miami, Miami, Florida, USA.
Diamant ThaçiUniversity of Lübeck, Lübeck, Germany.
Lone SkovDepartment of Dermatology and Allergy, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-4784-9680
Xiaoxiao ChenGalderma Laboratories, Dallas, Texas, USA.
Aliene NodaGalderma R&D, Zug, Switzerland.
Zarif K Jabbar-LopezGalderma R&D, Zug, Switzerland.
Christophe PikettyGalderma R&D, Zug, Switzerland.ORCID https://orcid.org/0000-0002-9969-2478
Sonja StänderCenter for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany.ORCID https://orcid.org/0000-0003-3612-7786

Funding

Galderma
6 · The paper itself

Abstract

backgroundPrurigo nodularis (PN) is a neuroimmune skin disease characterized by the presence of chronic itch (≥6 weeks) and multiple white-pink papules, nodules and/or plaques.

objectivesThe OLYMPIA long-term extension (OLYMPIA-LTE) trial evaluates long-term, over 184 weeks, safety and efficacy of nemolizumab in adults with moderate-to-severe PN.

methodsAdults with moderate-to-severe PN, who completed phase 2b (NCT03181503) and phase 3 (OLYMPIA 1&2) lead-in trials, were eligible for the ongoing OLYMPIA-LTE trial. Patients receiving nemolizumab monotherapy (continuous-nemolizumab) during lead-in trials continued their regimen, while those on placebo (nemolizumab-naïve) initiated nemolizumab monotherapy. The primary endpoint was long-term safety. Efficacy assessments included the proportion of patients achieving a ≥4-point improvement from baseline Peak Pruritus Numerical Rating Scale (PP-NRS4), Sleep Disturbance Numerical Rating Scale (SD-NRS4) and Dermatology Life Quality Index (DLQI4) scores, Investigator's Global Assessment (IGA) score 0/1 (clear/almost clear), and 75% healed pruriginous lesions (Prurigo Activity and Severity score item-5b). Observed cases up to week 100, regardless of rescue medication, are presented, without imputation of missing data.

resultsAt interim analysis data cut-off (21 July 2024), 290/508 (57%) patients completed week 100 (median exposure: 839.5 days). Treatment-emergent adverse events (TEAEs) occurred in 89% of patients (452/508; exposure time-adjusted incidence rate: 197.5/100 patient-years) and were mostly mild/moderate (26%/52%) in severity. TEAEs occurring in ≥5% of patients at any given year were COVID-19 (28%), nasopharyngitis (20%), upper respiratory tract infection (13%), neurodermatitis (worsening of PN; 13%), back pain (9%), headache (9%), arthralgia (9%), cough (8%), hypertension (8%) and nummular eczema (8%). At week 100, among evaluable patients treated with nemolizumab, 92% achieved PP-NRS4, 86% SD-NRS4, 91% DLQI4, 74% IGA 0/1 and 84% observed healing of >75% of pruriginous lesions.

conclusionsLong-term treatment with nemolizumab was well tolerated and led to disease control with clinically meaningful improvements in itch intensity, pruriginous lesions and quality of life. CLINICAL TRIAL REGISTRATION NO: NCT04204616, RD.06.SPR.202699 and 2019-004294-13 (EudraCT Number).

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsPrurigoAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPruritusSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic Agentsnemolizumabchronic prurigoIL‐31itchnemolizumabprurigo nodularispruritus

Identifiers

PMID41405008
PMCPMC13308661

What OpenQuestion holds

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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.