Evidence map›Paper›PMID 40704660›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab.

Andrew Blauvelt, Raj Chovatiya, Joseph F Merola, Stephan Weidinger, Ken Igawa, Ella Brookes, Christine Weber, Jennifer Wang, Cori Gray

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05131477 (A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT05131477 phase2completednot on this map

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorKymab LimitedRan2021 to 2024Enrolled390ConditionsEczema, Atopic DermatitisArmsAmlitelimab, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Trial
  2. Review
  3. OX40/OX40L modulation: A target for regulating T cells in cutaneous inflammatory disorders.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Review
  4. Review
  5. 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.

Andrew BlauveltBlauvelt Consulting LLC, Annapolis, Maryland, USA.ORCID https://orcid.org/0000-0002-2633-985X
Raj ChovatiyaChicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, USA.ORCID https://orcid.org/0000-0001-6510-399X
Joseph F MerolaDepartment of Dermatology and Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, O'Donnell School of Public Health, Dallas, Texas, USA.
Stephan WeidingerDepartment of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany.ORCID https://orcid.org/0000-0003-3944-252X
Ken IgawaDepartment of Dermatology, Dokkyo Medical University, Tochigi, Japan.ORCID https://orcid.org/0000-0001-5574-198X
Ella BrookesSanofi, Reading, UK.ORCID https://orcid.org/0009-0001-9710-3799
Christine WeberSanofi, Paris, France.
Jennifer WangSanofi, Boston, Massachusetts, USA.
Cori GraySanofi, Boston, Massachusetts, USA.

Funding

Sanofi
6 · The paper itself

Abstract

backgroundAmlitelimab, a fully human, nondepleting, anti-OX40 ligand monoclonal antibody, demonstrated reductions in lesional and pruritic endpoints in adults with moderate-to-severe atopic dermatitis (AD) in phase 2a and 2b trials.

objectivesHere, we examined the effect and durability of amlitelimab on clinical outcome assessments (COAs) in the randomized STREAM-AD phase 2b trial.

methodsAdults with moderate-to-severe AD with prior inadequate response to or inadvisability of topical medications received subcutaneous amlitelimab (250 mg with 500-mg loading dose, 250 mg, 125 mg or 62.5 mg) or placebo every 4 weeks in Part 1 (Weeks 0-24; 1:1:1:1:1 randomization). In Part 2, Week 24 clinical responders (defined as patients achieving Investigator Global Assessment [IGA] 0/1 and/or ≥ 75% reduction in the Eczema Area and Severity Index [EASI-75]) were rerandomized 3:1 to withdraw or continue amlitelimab pre-Week 24 dose through Week 52. COAs, including SCORing Atopic Dermatitis, affected body surface area, Patient-Oriented Eczema Measure, Dermatology Life Quality Index and Atopic Dermatitis Control Tool, were evaluated.

resultsOf the 390 randomized patients in Part 1, 190 were rerandomized in Part 2. Significant improvements in COAs were observed with all amlitelimab doses versus placebo at Week 24 (p < 0.05 for all COAs). At Week 24, the majority of clinical responders achieved meaningful changes in COAs. At Week 52, these improvements were maintained in the majority of patients who achieved COA improvements at Week 24, regardless of treatment continuation or withdrawal during the 28-week Part 2 period.

conclusionsAmlitelimab treatment led to clinically meaningful improvements in COAs by Week 24 versus placebo. COA improvements were maintained at Week 52 in patients continuing amlitelimab, as well as in patients who withdrew from amlitelimab, supporting the durable response of amlitelimab and the viability of extended drug dosing, which may ease treatment burden. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT05131477.

Indexed as

Antibodies, Monoclonal, HumanizedDermatitis, AtopicAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizedamlitelimabatopic dermatitisclinical outcome assessmentclinician‐reported outcomeOX40 ligandpatient‐reported outcome

Identifiers

PMID40704660
PMCPMC12645176

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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.