Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Summary

The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.

Timeline

Start

2014-08-31

Primary completion

2016-02-17

Completion

2017-01-30

Outcome

Met primary endpoint

paper At week 16, mean changes in esophageal eosinophil count per hpf were a reduction of 94.8 ± 67.3 in patients who received 180 mg RPC4046 (P < .0001) PMID 30395812 ↗

Publications

• Caldwell JM, Ballaban AY, Li J, Maddux R, Harris S, Dellon ES, Rothenberg ME. Cendakimab (anti-IL-13) administration improves esophageal gene expression in eosinophilic esophagitis. J Allergy Clin Immunol. 2026 Jan;157(1):118-130.e7. doi: 10.1016/j.jaci.2025.08.032. Epub 2025 Oct 9.
• Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I. Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):473-483.e17. doi: 10.1016/j.cgh.2020.03.036. Epub 2020 Mar 21.
• Hirano I, Collins MH, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer AM, Straumann A, Safroneeva E, Grimm M, Smith H, Tompkins CA, Woo A, Peach R, Frohna P, Gujrathi S, Penenberg DN, Li C, Opiteck GJ, Olson A, Aranda R, Rothenberg ME, Dellon ES; HEROES Study Group. RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis. Gastroenterology. 2019 Feb;156(3):592-603.e10. doi: 10.1053/j.gastro.2018.10.051. Epub 2018 Nov 2.

Drugs

Indications