At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
TIMP-GLIA +1 moredrug
Likely dose
TIMP-GLIA 8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study of the Safety, Pharmacodynamics, Efficacy, and Pharmacokinetics of TIMP-GLIA in Subjects With Well-controlled Celiac Disease Undergoing Oral Gluten Challenge
In Brief
A Phase 2 clinical trial evaluating TIMP-GLIA and Placebo for Celiac Disease. Completed, enrolled 34 participants across 8 sites.
Detailed Summary
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesUnited States
CollaboratorsCOUR Pharmaceutical Development Company, Inc.
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartNov 2018
First PostedNov 2018
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedNov 13, 2018
Enrollment StartNov 11, 2018
Primary CompletionJun 24, 2019
Study CompletionJul 22, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.6 years ago
Interventions
TIMP-GLIAdrug
8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8.
Placebodrug
Administered intravenously on days 1 and 8.