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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04835168
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Landos Biopharma Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jyoti Chauhan
Principal Investigator Affiliation	Landos Biopharma Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

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.

Arms & Interventions

Arms

Experimental: BT-11 500mg

Oral

Experimental: BT-11 1000mg

Oral

Placebo Comparator: BT-11 Placebo

Oral

Interventions

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).

Drug: - BT-11 1000mg

Drug: - BT-11 Placebo

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jyoti Chauhan

jyoti@landosbiopharma.com

5402182232

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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