At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 193 enrolled
Drug / intervention
ibrutinib +2 moredrug
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 Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)
In Brief
A Phase 3 clinical trial evaluating ibrutinib, Placebo, and 1 other intervention for Chronic Graft Versus Host Disease. Completed, enrolled 193 participants across 102 sites in 15 countries.
Detailed Summary
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft Versus Host Disease
CountriesAustralia, Austria, Canada, China, Croatia, France, Germany, Hungary, Italy, Japan, Singapore, South Korea, Spain, Taiwan, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartMay 2017
Primary CompletionMar 2020
Study CompletionJul 2021
TodayJul 2026
First PostedNov 9, 2016
Enrollment StartMay 11, 2017
Primary CompletionMar 27, 2020
Study CompletionJul 12, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.6 years ago
Interventions
ibrutinibdrug
Ibrutinib capsules administered orally daily
Placebodrug
Placebo capsules administered orally daily
Prednisonedrug
Prednisone administered daily