At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
AMG 714 +1 morebiological
Likely dose
Not stated in 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 Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating AMG 714 and Placebo for Type II Refractory Celiac Disease (RCD-II) and In-situ Small Bowel T-cell Lymphoma. Completed, enrolled 28 participants across 6 sites in 5 countries.
Detailed Summary
Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland, France, Netherlands, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartApr 2016
Primary CompletionApr 2017
Study CompletionMay 2017
TodayJul 2026
First PostedDec 17, 2015
Enrollment StartApr 13, 2016
Primary CompletionApr 11, 2017
Study CompletionMay 2, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.5 years ago
Interventions
AMG 714biological
Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.
Placebobiological
Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.