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

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

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04835168
Enrollment
0
Registered
2021-04-08
Start date
2022-01-30
Completion date
2022-06-30
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Brief summary

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

Interventions

DRUGBT-11 low

Oral

DRUGBT-11 high

Oral

DRUGPlacebo

Oral

Sponsors

NImmune Biopharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

No patients enrolled

Design outcomes

Primary

MeasureTime frame
Incidence and severity of AEs12 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026