Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 890 |
| INN | Rocatinlimab |
| Status | Clinical |
| Drug code(s) | KHK4083, AMG451 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (KM mouse) |
| Target(s) | OX40 |
| Indications of clinical studies | Prurigo Nodularis, Asthma, Ulcerative colitis, atopic dermatitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2012 |
| Start of Phase 2 | December 15, 2015 |
| Start of Phase 3 | May 31, 2022 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Kyowa Hakko Kirin |
| Licensee/Partner | Amgen |
| Comments about company or candidate | Phase 3 studies for Atopic dermatitis: (NCT05398445, NCT05633355, NCT05724199, NCT05704738, NCT05899816) are active non recruiting; NCT05651711 is completed; (NCT05882877, NCT06224192) are recruiting as of September-November 2024. Phase 3 study in Prurigo Nodularis NCT06527404 is recruiting as of November 2024. Sep 2024: The HORIZON trial readout, the first of eight pivotal study readouts in atopic dermatitis, showed statistically significant improvement observed in co-primary endpoints. https://investors.amgen.com/static-files/a7119a35-06de-497e-ba75-146404c54d95 NCT06527404 Phase 3 in Prurigo Nodularis started in July 2024. Amgen 2023 financial results (April 27, 2023) "The ROCKET Phase 3 program, composed of seven studies evaluating rocatinlimab, an anti-OX40 monoclonal antibody, is enrolling adult and adolescent patients with moderate to severe atopic dermatitis." https://www.amgen.com/newsroom/press-releases/2023/04/amgen-reports-first-quarter-financial-results . Phase 3 studies for Atopic dermatitis (NCT05398445, NCT05633355, NCT05651711, NCT05724199, NCT05704738, NCT05882877) are recruiting as of June 2023 (NCT05899816) is also recruiting as of June 2023. Aug 4, 2022: Kyowa revealed the partners have paused the study. The Japanese drugmaker provided a brief explanation for the U-turn in its financial results for the second quarter. “Following additional discussions with regulators and our partner, we are amending the studies to improve patient convenience and investigate a range of doses. No safety or efficacy issues have arisen". NCT05398445 is a A Phase 3, 52-week, Treat-through, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of AMG 451 Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis due to start in June 2022. Feb 2022: Amgen is planning to conduct a comprehensive Phase 3 program in atopic dermatitis with AMG 451, a monoclonal antibody that inhibits OX-40 resulting in the partial depletion of activated T-cells and the inhibition of T-cell activation cascade; study initiation is anticipated in mid-2022. Phase 3 study planned in H1 2022: https://ir.kyowakirin.com/en/library/earnings/earnings0/main/0113/teaserItems1/00/linkList/01/link/presentation_2021_q3_en.pdf June 1, 2021: Amgen and Kyowa Kirin Co., Ltd. have announced an agreement to jointly develop and commercialize KHK4083, which is Kyowa Kirin's potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis. In August 2020, the company has discontinued the Phase II stage of development for the treatment of ulcerative colitis in the US, EU and Others and Phase I stage of development for the treatment of ulcerative colitis in Japan. NCT03703102 Phase 2 study in atopic dermatitis started Oct 2018 active not recruiting as of Aug 2020. Phase 2 study in Ulcerative Colitis active completed as of Sep 2018. Phase 1 NCT03096223 study in atopic dermatitis started in April 2017. Started Phase 1 in Canada as per pipeline dated January 24, 2014 |
| Full address of company | Tokyo, Japan Asia Japan https://www.kyowakirin.com/index.html |
Immune checkpoint target. Potelligent KM mouse-derived; immunomodulator; enhanced effector functions
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |