rocatinlimab (KHK4083) / Kyowa Kirin, Amgen - LARVOL DELTA

Outcomes Following Discontinuation of Systemic Immunomodulatory Therapies in Adults with Atopic Dermatitis: A Systematic Review (EADV 2025) - "Six studies examined biologic agents (amlitelimab, dupilumab (2 studies), tralokinumab, rezpegaldesleukin, rocatinlimab) and three evaluated JAK inhibitors (baricitinib, abrocitinib, upadacitinib). Emerging evidence suggests that sustaining disease control following discontinuation of systemic immunomodulatory therapy is possible in some adults with AD. Differences in outcomes between therapies may reflect variations in drug mechanisms or study design. To confidently identify individuals who may benefit from treatment discontinuation, further studies are required with harmonised outcomes (e.g."

Clinical • Immunomodulating • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

Outcomes Following Discontinuation of Systemic Immunomodulatory Therapies in Adults with Atopic Dermatitis: A Systematic Review (EADV 2025) - "Six studies examined biologic agents (amlitelimab, dupilumab (2 studies), tralokinumab, rezpegaldesleukin, rocatinlimab) and three evaluated JAK inhibitors (baricitinib, abrocitinib, upadacitinib). Emerging evidence suggests that sustaining disease control following discontinuation of systemic immunomodulatory therapy is possible in some adults with AD. Differences in outcomes between therapies may reflect variations in drug mechanisms or study design. To confidently identify individuals who may benefit from treatment discontinuation, further studies are required with harmonised outcomes (e.g."

Clinical • Immunomodulating • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

Online Education Significantly Improved Dermatologists' Knowledge Of The Mode Of Action And Key Clinical Data On Emerging Therapies For Atopic Dermatitis That Target The OX40-OX40 Ligand Pathway. (EADV 2025) - "Dermatologists significantly improved their knowledge of survival of pathogenic T cells as a key consequence of OX40-OX40L interaction in the pathogenesis of AD (17% pre- vs 43% post-activity; P <.001), the mode of action of amlitelimab and rocatinlimab (21% pre- vs 55% post-activity; P <.001) and clinical data for these novel therapies (54% pre- vs 74% post-activity; P <.001). This online activity significantly improved dermatologists' understanding of the role of the OX40-OX40L pathway in the pathogenesis of AD and of emerging biologic therapies targeting this pathway. Although there was significant knowledge improvement for all questions, the post test scores of 43% to 74% indicate that dermatologists would benefit from additional education to embed their knowledge of emerging biologic therapies targeting this pathway in AD."

Clinical data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TNFSF4

Efficacy and Safety of OX40-Receptor Targeting With Rocatinlimab in Moderate-to-Severe Atopic Dermatitis: Results From the Phase 3 ROCKET-Ignite Trial (EADV 2025) - P3 | "ROCKET-Ignite met its co-primary endpoints in a diverse treatment-experienced AD patient population. ROCA significantly improved AD clinical signs and symptoms with even greater efficacy observed in the All Data analyses regardless of RT and no indication of efficacy plateau at Wk 24 and was generally well tolerated. Along with the previously reported ROCKET-Horizon study, data from ROCKET-Ignite confirm the efficacy of ROCA monotherapy in adults with AD."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pruritus

Rocatinlimab With Concomitant Topical Therapy Significantly Improved Clinical Signs and Symptoms of Atopic Dermatitis in Adults: Results From the Phase 3 ROCKET-SHUTTLE Trial (EADV 2025) - P3 | "ROCA combination therapy was well tolerated, and TEAEs were consistent with adult monotherapy studies. With the ROCKET-HORIZON and IGNITE monotherapy studies, ROCKET-SHUTTLE supports the efficacy and safety of ROCA administered with TCS/TCI."

Clinical • Late-breaking abstract • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pruritus

Late-breaking results from the phase 3 ROCKET-Ignite trial were presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress… (DermatologyTimes) - "In the full analysis set: EASI 75 response rates were 42.3% (300 mg) and 36.3% (150 mg) compared with 12.8% for placebo. vIGA-AD 0/1 response rates were 23.6% (300 mg) and 19.1% (150 mg) versus 8.7% for placebo. In the all-data analysis, irrespective of RT use, outcomes were more pronounced: EASI 75 response rates were 54.3% (300 mg) and 49.3% (150 mg) versus 20.1% for placebo. vIGA-AD 0/1 responses were 27% (300 mg) and 22.8% (150 mg) compared with 11.9% for placebo."

Late-breaking abstract • P3 data • Atopic Dermatitis

AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS (PRNewswire) - "This analysis focused on adults who completed the first 24 weeks of therapy in a previous ROCKET trial and continued in ASCEND for an additional 32 weeks....The discontinuation rate due to AEs was low across the adult rocatinlimab treated cohorts....Amgen and Kyowa Kirin plan to share full results at an upcoming congress or in a peer-reviewed publication."

P3 data: top line • Atopic Dermatitis

Kyowa Kirin Announces Late-Breaking Abstract Presentation at the European Academy of Dermatology and Venerology Congress (GlobeNewswire) - "Kyowa Kirin Co...announced that results of the Phase 3 ROCKET-SHUTTLE trial of rocatinlimab, an investigational T-cell rebalancing therapy, will be presented..."

Late-breaking abstract • P3 data • Atopic Dermatitis

Rocatinlimab: A Novel T-Cell Rebalancing Therapy Targeting the OX40 Receptor in Atopic Dermatitis. (PubMed, Dermatol Ther (Heidelb)) - "Rocatinlimab has also demonstrated a favorable safety and tolerability profile. A large, global phase 3 program (ROCKET) including eight studies is underway to further assess the efficacy, safety, maintenance of response, extended dosing, and off-treatment durability of rocatinlimab in adults and adolescents with moderate-to-severe AD."

IO biomarker • Journal • Review • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Inflammation • Pain • Pruritus • Psychiatry • Sleep Disorder

Rocatinlimab: Data readout from P3 ROCKET-ASCEND trial (NCT05882877) for moderate-to-severe atopic dermatitis in H2 2025 (Amgen) - Q2 2025 Results: Data readout from P3 ROCKET-ASTRO trial (NCT05704738) for moderate-to-severe atopic dermatitis in H2 2025

P3 data • Atopic Dermatitis • Immunology

ROCKET-Orbit: A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P3 | N=187 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Continuous-Time Markov Population PK/PD Modeling of Longitudinal EASI Categorical Score in Atopic Dermatitis Treated With Rocatinlimab, an Anti-OX40 Monoclonal Antibody. (PubMed, CPT Pharmacometrics Syst Pharmacol) - P1, P2 | "The PPK-PD model adequately described the time course and drug-related change in EASI score and was used to simulate various dosage regimens to predict the time course of EASI response. The identified parameters and drug-exposure relationship were considered to potentially support dose revisions and optimization for phase 3 trials in patients with moderate-to-severe AD that are utilizing a subcutaneous regimen with dosing every 4 weeks."

Journal • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Exacerbation of Crohn's Disease Following Exposure to Anti-OX40 Monoclonal Antibody Therapy. (PubMed, ACG Case Rep J) - "A 26-year-old man with Crohn's Disease (CD) presented to hospital with a CD flare after exposure to an anti-OX40 therapy (rocatinlimab) for eczema...Murine models have demonstrated mixed effects of anti-OX40 and anti-OX40 ligand therapies on colitis, and anti-OX40 therapy has been trialed in ulcerative colitis without significant clinical response seen. The impact of anti-OX40 therapies in patients with CD remains unclear, though this case suggests that caution may be required when using anti-OX40 therapies in this population."

Journal • Atopic Dermatitis • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress (PRNewswire) - "Kyowa Kirin Co., Ltd...today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025."

P3 data • Atopic Dermatitis

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=2200 | Recruiting | Sponsor: Amgen | Trial primary completion date: Jun 2025 ➔ May 2027

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

Rocatinlimab: “EASI-75 and vIGA-AD 0/1 Responses at Week 24”; Atopic dermatitis (Kyowa Hakko Kirin Pharma) - Kyowa Kirin rocatinlimab Update: “Depth of skin response for patients treated with rocatinlimab vs PBO continued to increase through Week 24”

P3 data • Atopic Dermatitis • Immunology

Rocatinlimab Significantly Improves Clinical Signs and Symptoms of Moderate-to-Severe Atopic Dermatitis by Specifically Reducing OX40R+ T-Cell Population Without Signs of Immunosuppression (EAACI 2025) - P3 | "Conclusion ROCA significantly improved clinical signs and symptoms of msAD (primary and AO analyses), reducing OX40R+ T cells while maintaining the overall T-cell population with no meaningful impact on infections. These data indicate clinical efficacy without signs of immunosuppression and support ROCA as a novel monotherapy option."

Clinical • IO biomarker • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Immunology

A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants (clinicaltrials.gov) - P1 | N=231 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A novel anti-OX40 human monoclonal antibody that blocks OX40/OX40L signaling and depletes OX40+ T cells. (PubMed, Mar Life Sci Technol) - "Interestingly, we also found that the most potent anti-OX40 antibody drug in the clinical stage, KHK4083, binds to different OX40 amino-acid residues, including Asp74, Lys82, Asp117, Ser118, Tyr119, and Lys120. This divergence suggests that the novel monoclonal antibody JY007 holds promise as a potential therapeutic option for patients with atopic dermatitis and may find broad applications in the treatment of autoimmune diseases. The online version contains supplementary material available at 10.1007/s42995-025-00284-y."

IO biomarker • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • Napsin A • TNFSF4

Biologics targeting OX40 and OX40L for treatment of atopic dermatitis have distinct inhibitory binding mechanisms (SID 2025) - "Our results provide initial prediction and analysis of the epitopes of OX40 and OX40L targeted biologics emerging for AD treatment. Rocatinlimab and amlitelimab appear to directly inhibit OX40-OX40L interactions via steric occlusion, with amlitelimab also possibly inhibiting OX40L trimer formation, whereas telazorlimab more specifically disrupts a critical intermolecular interaction."

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

Skin transcriptome modulation in Japanese patients with atopic dermatitis treated with rocatinlimab, an anti-OX40 receptor antibody (SID 2025) - P2 | "Pronounced gene signatures modulated vs BL were related to Th1, Th2, Th17, and Th22 cells, and markers of tissue resident memory T cells and epidermal barrier function (Wk 52, all p<0.05). Rocatinlimab induced durable efficacy with acceptable safety and meaningful biomarker responses, demonstrating potential T-cell rebalancing in Japanese patients with msAD."

Clinical • IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Emerging Therapies in the Treatment of Prurigo Nodularis: Biological Therapy and Systematic Review of Literature. (PubMed, Dermatol Ther (Heidelb)) - "Targeted therapies are revolutionizing PN treatment. Integrating clinical efficacy, immunologic endotyping, and real-world data will be pivotal to optimizing therapeutic strategies, enhancing outcomes, and personalizing care in prurigo nodularis."

IO biomarker • Journal • Review • Dermatology • Eosinophilia • Immunology • Inflammation • Prurigo Nodularis • Pruritus • CD123 • IL13 • IL31RA • IL4

OX40/OX40L as a Therapeutic Target in Atopic Dermatitis: A Scoping Review. (PubMed, Biologics) - "Moreover, early basic and clinical research has shown encouraging results regarding the efficacy and safety of therapies targeting the OX40-OX40L axis in moderate-to-severe AD. Therefore, herein we aim to summarize the current evidence regarding the efficacy and safety of inhibiting the OX40/OX40L signaling axis in patients with moderate-to-severe AD."

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

Safety and Efficacy of Anti-OX40 Therapies in Atopic Dermatitis: A Systematic Review and Meta-Analysis. (PubMed, Dermatitis) - "We aimed to systematically evaluate the efficacy and safety of anti-OX40 therapies (amlitelimab, rocatinlimab, and telazorlimab) in moderate-to-severe AD. In conclusion, anti-OX40 therapies demonstrate clinically meaningful efficacy and an acceptable safety profile for moderate-to-severe AD, offering a potential alternative for patients with inadequate responses to current treatments. Further research is warranted to confirm these results and to refine optimal dosing strategies."

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

Investigating Efficacy of Atopic Dermatitis Systemic Therapeutics After Discontinuation Part I: Biologics. (PubMed, J Clin Aesthet Dermatol) - "Five clinical trial programs met our inclusion criteria, each investigating a different biologic: dupilumab, tralokinumab, lebrikizumab, amlitelimab, and rocatinlimab. The variability in eligibility criteria, treatment durations, and withdrawal periods across trials presents a major challenge in assessing biologics for AD, complicating the comparison of their sustained responses in the absence of head-to-head studies. This heterogeneity, combined with factors such as disease duration and prior use of systemic medications before trial enrollment, hampers the identification of key pathways in AD pathogenesis and impedes efforts to better understand and characterize the disease."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology