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

Sponsor

Landos Biopharma Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04835168

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Drug: BT-11 500mg Drug: BT-11 1000mg Drug: BT-11 Placebo	Phase 1

Detailed Description

A total of 36 subjects with active eosinophilic esophagitis (≥ 15 eosinophils/HPF; SDI PRO ≥ 5) will be randomized in a 1:1:1 ratio to receive BT-11 500 mg twice daily, BT-11 1000 mg once daily, or placebo. Each of the treatment arms will comprise 12 subjects. The randomization will be stratified by ongoing PPI use at baseline (yes/no) and prior corticosteroid use (yes/no).

The study will consist of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period. A final analysis will be conducted after all subjects have reached Week 12.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

Anticipated Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BT-11 500mg Oral	Drug: BT-11 500mg Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).
Experimental: BT-11 1000mg Oral	Drug: BT-11 1000mg Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).
Placebo Comparator: BT-11 Placebo Oral	Drug: BT-11 Placebo Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).

Arm

Intervention/Treatment

Experimental: BT-11 500mg

Oral

Drug: BT-11 500mg

Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).

Experimental: BT-11 1000mg

Oral

Drug: BT-11 1000mg

Placebo Comparator: BT-11 Placebo

Oral

Drug: BT-11 Placebo

Outcome Measures

Primary Outcome Measures

Incidence and severity of AEs [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Landos Biopharma Inc.

Investigators

Study Director: Simon Lichtiger, MD, Landos Biopharma Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Landos Biopharma Inc.

ClinicalTrials.gov Identifier:

NCT04835168

Other Study ID Numbers:

BT-11-EoE

First Posted:

Apr 8, 2021

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophagitis

Eosinophilic Esophagitis

Study Results

No Results Posted as of Mar 25, 2022