Drugs / Rocatinlimab
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05891119 | Jun 2023 → Aug 2024 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT06438263 | Aug 2024 → May 2025 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06268860 | Feb → Aug 2024 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06214481 | Jan → May 2024 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT03096223 | Apr 2017 → Feb 2018 | atopic eczema | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02985593 | Dec 2016 → Dec 2017 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT06376045 | May 2024 → May 2026 | asthma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT03703102 | Oct 2018 → Feb 2020 | atopic eczema | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 2 | NCT02647866 | Jun 2016 → Sep 2018 | autoimmune disease, ulcerative colitis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary | ||||||
| Phase 3 | NCT06527404 | Jul 2024 → Apr 2026 overdue | prurigo nodularis | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05899816 | Jun 2023 → Aug 2024 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT05882877 | May 2023 → Jul 2026 | atopic eczema | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05704738 | Apr 2023 → Feb 2025 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT05724199 | Feb 2023 → Sep 2024 | atopic eczema | Amgen | Completed | Met primary |
| Phase 3 | NCT05633355 | Jan 2023 → Jul 2025 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT05651711 | Dec 2022 → Jun 2024 | atopic eczema | Amgen | Completed | Met primary |
| Phase 3 | NCT05398445 | May 2022 → Nov 2024 | atopic eczema | Amgen | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06224192 Background | Apr 2024 → Apr 2025 | atopic eczema | Amgen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-03-03 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Discontinuation of Rocatinlimab Clinical Trials kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, today announced the discontinuation of all ongoing clinical trials for rocatinlimab, an investigational an-ti-OX40 monoclonal antibody being evaluated for potential indications in moderate-to-severe atopic dermatitis, moderate-to-severe uncontrolled asthma, and prurigo nodularis. |
| 2025-09-08 | Amgen | Results 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 amgen.com ↗
Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). |
| 2025-03-08 | Amgen | Results AMGEN AND KYOWA KIRIN PROVIDE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 IGNITE STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS amgen.com ↗
The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. |
| 2025-02-27 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Late-Breaking Abstract Presentation at the American Academy of Dermatology Annual Meeting 2025 kyowakirin.com ↗
Rocatinlimab Significantly Improved Clinical Signs and Symptoms by Targeting OX40R+ T cells in Patients with Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET HORIZON Trial |
| 2024-09-25 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Top-line Data from Rocatinlimab Phase 3 ROCKET HORIZON Trial for Adults with Moderate to Severe Atopic Dermatitis kyowakirin.com ↗
Tokyo, Japan, September 25, 2024 -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. |
| 2024-03-11 | Kyowa Kirin, Inc. | Results Kyowa Kirin Will Present Phase 2b Post-hoc Analysis and Symposium at the American Academy of Dermatology Annual Meeting 2024 kyowakirin.com ↗
Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-toSevere Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study |
| 2024-03-09 | Amgen | Results AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024 amgen.com ↗
Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-to-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study |
| 2023-03-17 | Kyowa Kirin, Inc. | Results Kyowa Kirin Will Present New Rocatinlimab Phase 2b Data in Atopic Dermatitis at the American Academy of Dermatology Annual Meeting 2023 kyowakirin.com ↗
Rocatinlimab demonstrates a significant reduction in IgE concentrations in addition to clinical efficacy measures in patients with moderate–severe atopic dermatitis (msAD) in a randomised, double-blind, placebo-controlled Phase 2 trial |
| 2023-03-07 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Acceptance for Presentation of Two Posters at the American Academy of Dermatology Annual Meeting 2023 kyowakirin.com ↗
Rocatinlimab demonstrates a significant reduction in IgE concentrations in addition to clinical efficacy measures in patients with moderate-severe atopic dermatitis (msAD) in a randomised, double-blind, placebo-controlled Phase 2 trial |
| 2022-08-30 | Amgen | Results AMGEN TO PRESENT NEW, POSITIVE CLINICAL AND REAL-WORLD DATA ACROSS INFLAMMATION PORTFOLIO AT EADV 2022 amgen.com ↗
Rocatinlimab demonstrates improvements in head and neck atopic dermatitis in patients with moderate-severe disease in a phase 2 trial |
| 2021-10-02 | Kyowa Kirin, Inc. | Results Kyowa Kirin and Amgen Present Positive Late-Breaking Data from Phase 2 Study of KHK4083/AMG 451 in Adult Patients with Moderate-to-Severe Atopic Dermatitis at EADV Congress The study met its primary objective of demonstrating statistically greater improvement from baseline in Eczema Area and Severity Index score at 16 weeks versus placebo Patients receiving KHK4083/AMG 451 showed statistically greater improvements in additional secondary efficacy endpoints versus placebo KHK4083/AMG 451 also showed progressive improvement in efficacy beyond 16 weeks kyowakirin.com ↗ |
| 2021-10-02 | Amgen | Results Amgen And Kyowa Kirin Present Positive Late-Breaking Data From Phase 2 Study Of AMG 451/KHK4083 In Adult Patients With Moderate-to-Severe Atopic Dermatitis At EADV Congress amgen.com ↗
Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE:4151) today announced that positive data from a Phase 2 study of AMG 451/KHK4083 were presented at the European Academy of Dermatology and Venereology 30 th Virtual Congress on Oct. 2, 2021 . |
| 2021-02-18 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Positive Phase 2 Results for KHK4083 in Patients with Moderate to Severe Atopic Dermatitis kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (TSE: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin"), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, announces today that the Phase 2 study of investigational agent KHK4083 in patients with atopic dermatitis has met the primary endpoint. |
All press releases naming this drug 17 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rocatinlimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05891119 ↗ |
| Known as | AMG 451 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594567 ↗ |
| Known as | KHK4083 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03703102 ↗ |
| Known as | KLK4083 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594567 ↗ |
| Action | Inhibit | “inhibits and reduces the number of pathogenic T cells by targeting the OX40 receptor” PMID 41314226 ↗ Nov 20251“Tumor necrosis factor receptor superfamily member 4 antagonist” CHEMBL4594567 ↗ |
| Modality | Monoclonal antibody | “Anti-OX40 Monoclonal Antibody” NCT02647866 ↗ |
| Route | Intravenous | “IV Infusion” NCT02647866 ↗ |
| Target | TNFRSF4 | “Tumor necrosis factor receptor superfamily member 4 antagonist” CHEMBL4594567 ↗ |