Evidence map›Paper›PMID 40012373›Full record

ArticleImmunotherapy2025

ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis.

Emma Guttman-Yassky, Eric Simpson, Robert Bissonnette, Lawrence F Eichenfield, Kenji Kabashima, Paula C Luna, Janá Tresnak Hercogová, Lynda Spelman, Margitta Worm, Ehsanollah Esfandiari and 5 more

8 registry-linked trialsAbstract read
In one paragraph

Article in Immunotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT05398445 phase3completednot on this map

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

TypeinterventionalSponsorAmgenRan2022 to 2025Enrolled769ConditionsAtopic DermatitisArmsRocatinlimab, Placebo
NCT05633355 phase3completednot on this map

A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

TypeinterventionalSponsorAmgenRan2023 to 2025Enrolled187ConditionsAtopic DermatitisArmsRocatinlimab
NCT05651711 phase3completednot on this map

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

TypeinterventionalSponsorAmgenRan2022 to 2024Enrolled726ConditionsAtopic DermatitisArmsRocatinlimab, Placebo
NCT05704738 phase3completednot on this map

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

TypeinterventionalSponsorAmgenRan2023 to 2025Enrolled532ConditionsAtopic DermatitisArmsRocatinlimab, Placebo
NCT05724199 phase3completednot on this map

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

TypeinterventionalSponsorAmgenRan2023 to 2024Enrolled746ConditionsAtopic DermatitisArmsRocatinlimab, Placebo
NCT05882877 phase3terminatednot on this map

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

TypeinterventionalSponsorAmgenRan2023 to 2026Enrolled2,621ConditionsAtopic DermatitisArmsRocatinlimab, Placebo
NCT05899816 phase3completednot on this map

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

TypeinterventionalSponsorAmgenRan2023 to 2024Enrolled221ConditionsAtopic Dermatitis, Moderate-to-severe Atopic DermatitisArmsRocatinlimab, Placebo
NCT06224192 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)

TypeinterventionalSponsorAmgenRan2024 to 2026Enrolled151ConditionsAtopic DermatitisArmsRocatinlimab Prefilled Syringe, Rocatinlimab AI
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Atopic Dermatitis: New Targets and Emerging Systemic Therapies.American journal of clinical dermatology · 2026
    Review
  2. 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
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. New Topical and Systemic Treatments for Atopic Dermatitis.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025
    Review
  10. Review
  11. Article
  12. 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

15 authors.

Emma Guttman-YasskyDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-9363-324X
Eric SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, OR, USA.
Robert BissonnetteInnovaderm, Montreal, Québec, Canada.ORCID 0000-0001-5927-6587
Lawrence F EichenfieldDepartment of Dermatology, University of California San Diego, La Jolla, CA, USA.ORCID 0000-0002-2760-0474
Kenji KabashimaDepartment of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-0773-0554
Paula C LunaServicio de Dermatología, Hospital Aleman, Buenos Aires, Argentina.
Janá Tresnak HercogováDermatology Prof. Hercogova, Prague, Czech Republic.ORCID 0000-0003-1702-5995
Lynda SpelmanVeracity Clinical Research, Brisbane, Australia.ORCID 0000-0002-7330-4713
Margitta WormDepartment of Dermatology, Venerology and Allergology, Charité, Universitätsmedizin Berlin, Berlin, Germany.
Ehsanollah EsfandiariKyowa Kirin International, London, UK.
Takahiro AraiKyowa Kirin, Inc, Princeton, NJ, USA.
Hirotaka ManoKyowa Kirin Co. Ltd, Tokyo, Japan.
Prista CharuwornAmgen Inc., Thousand Oaks, CA, USA.
Andrea WangAmgen Inc., Thousand Oaks, CA, USA.
Gregory KricorianAmgen Inc., Thousand Oaks, CA, USA.ORCID 0000-0002-9419-9836

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Atopic dermatitis (AD) is a chronic inflammatory disease affecting ~ 10% of adults and ~ 20% of children globally. Many patients with moderate-to-severe AD receiving systemic therapies, including biologics and Janus kinase (JAK) inhibitors, fail to reach or maintain treatment goals due to lack of durable response or safety/tolerability issues. Rocatinlimab is a T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. ROCKET, a large, global phase 3 program of eight clinical trials (NCT05398445; NCT05651711; NCT05724199; NCT05899816; NCT05704738; NCT05633355; NCT05882877; NCT06224192), will evaluate the efficacy, durability of response, and long-term safety of rocatinlimab as monotherapy and combination therapy in adult and adolescent patients with moderate-to-severe AD with or without prior exposure to biologics or systemic JAK inhibitors.

Indexed as

Antibodies, Monoclonal, HumanizedDermatitis, AtopicAdolescentAdultChildClinical Trials, Phase III as TopicFemaleHumansMaleSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedAtopic dermatitisOX40OX40 receptorphase 3rocatinlimabT-cell–mediated inflammationT-cell rebalance

Identifiers

PMID40012373
PMCPMC11901500

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Registered trials

and 2 more above

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.