Drugs / Rocatinlimab
Trials 17 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT02647866 | Jun 2016 → Sep 2018 | autoimmune disease, ulcerative colitis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT05398445 | May 2022 → Nov 2024 | atopic eczema | Amgen | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06224192 Background | Apr 2024 → Apr 2025 | atopic eczema | Amgen | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-08 | Amgen | 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 ↗ |
| 2025-03-08 | Amgen | AMGEN AND KYOWA KIRIN PROVIDE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 IGNITE STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS amgen.com ↗ |
| 2021-10-02 | Amgen | 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 ↗ |
| 2021-06-01 | Amgen | Amgen and Kyowa Kirin to Jointly Develop and Commercialize KHK4083, a Phase 3-Ready, Potential First-In-Class Treatment for Atopic Dermatitis amgen.com ↗ |
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 NCT05633355 ↗ |
| 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 NCT02985593 ↗ |
| 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 ↗ |