NCT02199496View on ClinicalTrials.gov

Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

October 19, 2015

Primary Completion Date

August 16, 2019

Study Completion Date

July 10, 2020

Conditions
Gastrointestinal Inflammation Associated With CVIDCVID Enteropathy
Interventions
BIOLOGICAL

Stelara (ustekinumab)

"* In the single-phase part of the study, subjects receive a single dose of Stelara (ustekinumab) 270 mg subcutaneously on Day 0 study visit.~* In the multi-phase part of the study, subjects receive single dose of Stelara (ustekinumab) 270 mg subcutaneously on Day 0 study visit with follow up dose of Stelara (ustekinumab) 90 mg subcutaneously at Week 8, Week 16, Week 24, Week 32 and Week 40"

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02199496 - Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency | Biotech Hunter | Biotech Hunter