Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
Summary
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
Timeline
- Start
- 2018-10-22
- Primary completion
- 2020-02-06
- Completion
- 2020-11-12
Outcome
Met primary endpoint
paper Compared with placebo (-15·0 [95% CI -28·6 to -1·4]), significant least-squares mean percent reductions in EASI score at week 16 were observed in all rocatinlimab groups PMID 36509097 ↗
registry analysis (superiority test); KHK4083 150 mg SC Q4W vs Placebo/KHK4083 600 mg; p < 0.001; ANCOVA NCT03703102 ↗
registry analysis (superiority test); KHK4083 600 mg SC Q4W vs Placebo/KHK4083 600 mg; p < 0.001; ANCOVA NCT03703102 ↗
registry analysis (superiority test); KHK4083 300 mg SC Q2W vs Placebo/KHK4083 600 mg; p < 0.001; ANCOVA NCT03703102 ↗
registry analysis (superiority test); KHK4083 600 mg SC Q2W vs Placebo/KHK4083 600 mg; p < 0.001; ANCOVA NCT03703102 ↗
Publications
- Gooderham M, Guttman-Yassky E, Igawa K, Kabashima K, Esfandiari E, Rylands AJ, Williams A, Nixon A, Dent JE, Simpson E. Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3351-3366. doi: 10.1007/s13555-024-01303-z. Epub 2024 Nov 12.
- Guttman-Yassky E, Simpson EL, Reich K, Kabashima K, Igawa K, Suzuki T, Mano H, Matsui T, Esfandiari E, Furue M. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2023 Jan 21;401(10372):204-214. doi: 10.1016/S0140-6736(22)02037-2. Epub 2022 Dec 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rocatinlimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Rocatinlimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Rocatinlimab | Monoclonal antibody | 600 mg | Subcutaneous |