NCT02959944

Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	ibrutinib	Ibrutinib capsules administered orally daily
DRUG	Placebo	Placebo capsules administered orally daily
DRUG	Prednisone	Prednisone administered daily

Timeline

• Start date: 2017-05-11
• Primary completion: 2020-03-27
• Completion: 2021-07-12
• First posted: 2016-11-09
• Last updated: 2023-03-30
• Results posted: 2021-05-04

Locations

102 sites across 15 countries: United States, Australia, Austria, Canada, China, Croatia, France, Germany, Hungary, Italy, Japan, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study