Clinical Trials

Inclusion Criteria:

• Men or women between 18 and 65 years of age at the time of informed consent (IC).
• Have an EoE diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils (eos)/high power field (hpf) (~ 60 eos/mm^2 ) from any level (proximal, mid, or distal) of the esophagus at the Screening esophagogastroduodenoscopy (EGD).
• Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks (as documented using the Dysphagia Symptom Questionnaire (DSQ) during the Screening period).

Exclusion Criteria:

• History of any of the following non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic, endoscopic, or symptom endpoints of the study:
  • Conditions that cause or potentially contribute to esophageal eosinophilia (eg, eosinophilic gastritis [EG], gastroenteritis, or colitis with esophageal involvement, severe gastroesophageal reflux disease [GERD], achalasia and other disorders of esophageal dysmotility, hypereosinophilic syndrome, Crohn’s disease [CD] with esophageal involvement, esophageal infection [fungal, viral], connective tissue diseases, hypermobility syndromes, autoimmune disorders and vasculitides, dermatologic conditions with esophageal involvement [ie, pemphigus], drug hypersensitivity reactions, pill esophagitis, graft versus host disease, Mendelian disorders [e.g., Marfan syndrome Type II, hyper-immunoglobulin E (IgE) syndrome, phosphatase and tensin homolog hamartoma tumor syndrome, Netherton syndrome, severe atopy metabolic wasting syndrome]);
  • Conditions that interfere with the evaluation of the esophagus (e.g., esophageal varices with risk of spontaneous bleed, high-grade esophageal stenosis where an 8- to 10-mm endoscope could not pass through the stricture without dilation at the time of Screening EGD);
  • Conditions or procedures that cause or potentially contribute to dysphagia (e.g., Barrett’s esophagus, erosive esophagitis Los Angeles Grade B or above, significant hiatal hernia [≥ 4 cm], esophageal resection, fundoplication, gastric sleeve surgery).
• Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD.
• Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD.
• Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Subjects on any of the following therapy need to stay on a stable regimen during study participation:
  • Elemental diet;
  • EoE food trigger elimination diet;
  • PPI therapy.
• Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD Note: Stable (i.e., ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Subjects on SCIT need to stay on a stable treatment during study participation.
• Used any of the following immunomodulatory therapies within the timeframes prior to Baseline as indicated below. The Medical Monitor should be consulted with any questions related to prior use of unlisted immunomodulatory therapies.

Eligibility last updated 2/22/22. Questions regarding updates should be directed to the study team contact.