Clinical Trials Logo
  1. Home
  2. Eosinophilic Esophagitis
  3. NCT04835168
  4. Details
NCT04835168 Clinical Trial

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

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04835168
Other study ID # BT-11-EoE
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 30, 2022
Est. completion date June 30, 2022

Study information
Verified date June 2023
Source NImmune Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility No patients enrolled

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BT-11 low
Oral
• BT-11 high
Oral
• Placebo
Oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NImmune Biopharma

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of AEs 12 Weeks
See also
  Status Clinical Trial Phase
Completed NCT03382678 - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
Recruiting NCT04991935 - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis Phase 3
Not yet recruiting NCT05896891 - San Raffaele EoE Biobank
Active, not recruiting NCT05482256 - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis N/A
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
Completed NCT00961233 - Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) N/A