Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The proposed Phase 1b study design is a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.

The primary and secondary objectives of this study is to establish safety and pharmacokinetics of orodispersible BT-11 in active eosinophilic esophagitis (EoE).

The exploratory objectives of this study will include effects on disease activity measured by symptoms, endoscopy, histology and biomarkers, health-related quality of life, pharmacokinetics, and safety.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Landos Biopharma Inc.

Criteria

Inclusion Criteria:

• male and female subjects aged 18 to 65 years with a diagnosis of eosinophilic esophagitis for at least 3 months;

• active eosinophilic esophagitis with ≥ 15 eosinophils/HPF in at least 2 of 3 biopsied levels of the esophagus (distal, mid, or proximal), SDI PRO ≥ 5 and 2 or more episodes of dysphagia per week on average; willing to adhere to a stable diet throughout the study.

Exclusion Criteria:

• any active or history of gastrointestinal conditions aside from eosinophilic esophagitis including Crohn's disease, ulcerative colitis, celiac disease or achalasia;

• gross endoscopic abnormalities in the stomach or duodenum at baseline or found on biopsy specimens;

• impending or history of need for esophageal surgery;

• esophageal strictures incapable of being passed by endoscope without dilation;

• use of biologics, corticosteroids, or immunosuppressants within 4 weeks or 5 half-lives prior to baseline, whichever is longer;

• recent bacterial, fungal or viral infection prior to screening or baseline;

• presence or history of any medical condition, including cancer, that may influence the results of the study