rocatinlimab (AMG 451) / Kyowa Kirin, Amgen - LARVOL DELTA

Efficacy and Safety of Subcutaneous Rocatinlimab in Adults With Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Placebo-Controlled Trials. (PubMed, Dermatol Res Pract) - "However, the available evidence does not establish durable remission, prevention of recurrence, long-term disease modification or a favourable long-term benefit-risk profile. Given the subsequent discontinuation of the rocatinlimab clinical development programme following safety review, these findings should be interpreted cautiously as a synthesis of short-term trial evidence rather than support for future clinical use."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

OX40/OX40L Clinical Response Lag: A Systematic Review And Pharmacodynamic Analysis Of Amiltelimab, Rocatinlimab, And Ivarmacitinib. Proposing A New "Delayed Onset" Classification System For T-Cell Rebalancing Therapies In Atopic Dermatitis (EADV 2026) - No abstract available

Clinical • PK/PD data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TNFSF4

The "OX40 Paradox": A Systematic Review Investigating the Temporal Lag in Clinical Response for OX40/OX40L Inhibitors (Amlitelimab, Rocatinlimab)-Defining a New "Induction-Maintenance" Sequence Model (EADV 2026) - No abstract available

Clinical • Review • TNFSF4

A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=317 | Terminated | Sponsor: Amgen | Completed ➔ Terminated; Sponsor Decision

Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Reassessing the OX40/OX40L axis in atopic dermatitis after the termination of Rocatinlimab's clinical development program. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TNFSF4

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis (clinicaltrials.gov) - P3 | N=469 | Terminated | Sponsor: Amgen | Trial completion date: Jan 2027 ➔ Jun 2026 | Active, not recruiting ➔ Terminated; Sponsor Decision

Trial completion date • Trial termination • Immunology • Prurigo Nodularis

A phase 2, double-blind, placebo-controlled, dose-range determination study evaluating rocatinlimab for the treatment of moderate to severe asthma. (clinicaltrials.gov) - P2 | N=317 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Recruiting ➔ Terminated

Trial completion • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

ROCKET-ASCEND: A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P3 | N=2621 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ROCKET-ASTRO: A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P3 | N=532 | Completed | Sponsor: Amgen | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Is Kaposi's sarcoma the end of the OX40/OX40L axis in atopic dermatitis? (PubMed, Front Immunol) - "The discontinuation of rocatinlimab after confirmed and suspected cutaneous Kaposi's sarcoma cases, together with two cumulative cases reported in the amlitelimab program in patients with known risk factors, has changed the discussion from early promise to mechanism, risk, and therapeutic strategy. The central challenge is now to determine how the axis can be targeted, in which patients, and in what therapeutic context, to maximize clinical benefit while managing risk. Rather than signaling the end of the axis in atopic dermatitis, Kaposi's sarcoma may instead mark the limits of a first-generation development strategy and the beginning of a more selective approach built around molecule design, therapeutic context, and prospective risk mitigation."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Kaposi Sarcoma • Oncology • Sarcoma • Solid Tumor • TNFSF4

A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=317 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Dec 2026 ➔ Jun 2026 | Trial primary completion date: Oct 2026 ➔ May 2026

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis (clinicaltrials.gov) - P3 | N=469 | Active, not recruiting | Sponsor: Amgen | Trial primary completion date: Oct 2026 ➔ Apr 2026

Trial primary completion date • Immunology • Prurigo Nodularis

ROCKET-ASCEND: A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P3 | N=2621 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Jun 2027 ➔ Jun 2026 | Trial primary completion date: Jun 2027 ➔ Jun 2026

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

OX40/OX40L modulation: A target for regulating T cells in cutaneous inflammatory disorders. (PubMed, J Eur Acad Dermatol Venereol) - "Studies of amlitelimab and rocatinlimab have shown some efficacy but have demonstrated increased durability of response. Current concerns with the class are the potential for broad immune suppression with antagonists and the potential for worsening disease with agonists. Additional studies will enable us to determine their benefit-risk ratio in the real-world setting."

Journal • Review • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis • TNFSF4

Rocatinlimab atopic dermatitis in two global phase 3 clinical trials. (PubMed, Lancet) - No abstract available

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Model-Informed Development of STAR-0310: Supporting Every-3-Month and Every-6-Month Dosing in Atopic Dermatitis (AAD 2026) - P1 | "A mechanistic model linking OX40 inhibition to Eczema Area and Severity Index (EASI) response was developed using data from telazorlimab and rocatinlimab, a structurally unrelated anti-OX40 antibody. Quantitative pharmacology modeling, supported by Phase 1a clinical data, positions STAR-0310 as a differentiated OX40 antagonist. Extended intervals, combined with high potency, and reduced ADCC, may reduce treatment burden and improve adherence, thus expanding therapeutic options in AD."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Preclinical and first-in-human clinical evaluation of STAR-0310: A Differentiated OX40 Antagonist (AAD 2026) - P1 | "Results STAR-0310 demonstrated strong binding to human OX40 with robust inhibition of Th1, Th2, and Th17/22 cytokines, and 46-fold less Treg depletion than an in-house rocatinlimab analogue, consistent with its low-ADCC profile. Conclusion STAR-0310 combines high potency, reduced ADCC, extended half-life, and has potential for up to every six months administration. Interim clinical data align with preclinical results, and provide early proof of concept for STAR-0310 as a differentiated OX40 antagonist with potential to expand therapeutic options for moderate-to-severe AD and other immunologic diseases."

First-in-human • IO biomarker • P1 data • Preclinical • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • IL2 • IL4 • TNFSF4

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents. (PubMed, Cureus) - "This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures.  A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=151 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Dupilumab Outperforms Approved and Investigational Biologic Monotherapies in Moderate-to-Severe Atopic Dermatitis (AAD 2026) - " Seventeen RCTs (n=5508) compared dupilumab, tralokinumab, lebrikizumab, rocatinlimab, amlitelimab and rezpegaldesleukin with placebo at week 16 (rocatinlimab 300mg, 24 weeks). Dupilumab 300mg was the most effective biologic for moderate-to-severe AD, achieving both the strongest relative efficacy and the highest SUCRA ranking. Lebrikizumab emerged as a close second, particularly for itch improvement."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The OX40/OX40L Axis Promotes Th2 Activity and Impairs Regulatory T Cell Function in Atopic Dermatitis. (PubMed, Allergy) - "AD patients exhibit significant upregulation of OX40 expression in effector and regulatory CD4+ T cells. Both subsets interact with OX40L-expressing cells in the skin, leading to the promotion of skin inflammation by downregulation of function and anti-inflammatory capacity of Tregs."

IO biomarker • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CD4 • IL10 • TNFRSF4 • TNFSF4

Rocatinlimab Does Not Impact Vaccination-Induced Immune Responses in Adults With Moderate-to-Severe Atopic Dermatitis: Results From the Phase 3 ROCKET-VOYAGER Trial (AAAAI 2026) - P3 | "Conclusions ROCA did not impact IgG responses to tetanus and meningococcal vaccination and no new safety signals were observed. Alongside ROCKET-HORIZON, IGNITE and SHUTTLE, VOYAGER supports ROCA use in patients with moderate-to-severe AD."

Clinical • Late-breaking abstract • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Meningococcal Infections • Tetanus

Kyowa Kirin Announces Discontinuation of Rocatinlimab Clinical Trials (The Manila Times) - "This decision was informed by a recent planned safety update from the global rocatinlimab clinical program. Based on this update, Kyowa Kirin and Amgen have concluded that the potential risks may outweigh the benefits for the studied patient populations. This determination reflects the totality of emerging safety information, including previously reported safety risks...The most recent safety review conducted over the last several weeks identified emerging concerns of malignancies with possible viral or immune-related links....Both companies are currently notifying clinical trial investigators and regulatory authorities. After trial participants complete required safety follow-up visits, all studies will be formally terminated."

Trial termination • Asthma • Atopic Dermatitis • Immunology • Prurigo Nodularis

Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis (The Manila Times) - "Regulatory submission is planned in the first half of 2026...Previously announced topline results from the primary analysis of the long-term safety extension study ROCKET-ASCEND demonstrated the potential for long-term therapeutic effect and extended dosing...Results from this trial will be presented at an upcoming medical conference....The company plans to file for regulatory approval in the U.S. first, followed by Japan, before expanding to other markets across the world as appropriate."

Commercial • FDA filing • Japan filing • P3 data • Atopic Dermatitis

Molecular differentiation of OX40 and OX40L targeted biologics using AlphaFold3 and molecular dynamics simulations. (PubMed, J Invest Dermatol) - "Our analysis suggests rocatinlimab and amlitelimab directly inhibit OX40-OX40L interactions by physically blocking the cognate OX40-OX40L interface via steric occlusion, whereas telazorlimab disrupts a critical OX40-OX40L bond. Together, this work provides molecular characterization of the epitopes of OX40 and OX40L targeted biologics emerging in dermatology."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TNFSF4