Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Conditions

Eosinophilic Esophagitis

Brief 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.

Caldwell JM, Ballaban AY, Li J, Maddux R, Harris S, Dellon ES, Rothenberg ME.

2025-10-09

10.1016/j.jaci.2025.08.032

Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis.

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.

2020-03-2169 citations

10.1016/j.cgh.2020.03.036

RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis.

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.

2018-11-02189 citations

10.1053/j.gastro.2018.10.051

RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 α1 and α2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study.

Tripp CS, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, Wu C, Cherniack AD, Kim K.

2017-04-2834 citations

10.1007/s12325-017-0525-8

A Randomized, Double-Blind, Placebo-Controlled Trial of a Novel Recombinant, Humanized, Anti-Interleukin-13 Monoclonal Antibody (RPC4046) in Patients with Active Eosinophilic Esophagitis: Results of the HEROES Study

Evan S. Dellon, Margaret H. Collins, Yehudith Assouline-Dayan, Larry Evans, Sandeep Kumar Gupta et al. (18 authors)

The American Journal of Gastroenterology2016-09-2920 citations

10.1038/ajg.2016.356

Interventions

DRUGRPC4046

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Histologic evidence of EoE * Clinical symptoms of EoE including dysphagia

Exclusion criteria

* Primary causes of esophageal eosinophilia other than EoE

Design outcomes

Primary

Measure	Time frame
Mean Eosinophil Count	Week 16

Countries

Canada, Switzerland, United States

Outcome results

None listed