M16-763 Phase 2 Extension Study to M16-063
Research type
Research Study
Full title
A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)
IRAS ID
259579
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2018-002306-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This blinded phase 2 long term extension study is investigating the long-term safety, tolerability and efficacy of ABBV-105 and ABBV-599 in patients with rheumatoid arthritis (RA) that have had an inadequate response to bDMARDs. ABBV-105 is new Bruton’s tyrosine kinase (Btk) inhibitor that is being developed for the treatment of auto-immune inflammatory diseases including RA. Btk is involved in the cell signalling of immune-receptors that leads to inflammation in RA. ABBV-599 is a combination of ABBV-105 and Upadacitinib, a Janus Kinase (JAK) Inhibitor that is already being investigated in patients with RA. Upadacitnib is a selective JAK1 inhibitor and it is thought that the combination of Btk inhibition and JAK inhibition may increase the percentage of patients responding well to treatment.
This extension study will enroll patients who have completed M16-063. Patients who are eligible for the study will continue on their M16-063 study treatment in a blinded fashion apart from patients previously receiving placebo. Placebo patients will receive ABT-599. Neither the patients nor their doctors will know which group they have been assigned. Group 1 will receive ABBV-599 (Upadacitinib and a high dose of ABBV-105, each taken as a tablet daily). Groups 2, 3 and 4 will receive a high, medium and low dose of ABBV-105 with Upadacitinib placebo respectively and group 5 will receive Upadacitinib with ABBV-105 placebo. Patients take four tablets daily to maintain the blinded nature of the study for up to 12 weeks. Patients will attend visits at Baseline on Week 12 of their M16-063 visit schedule and then, Week 18, Week 24, Week 30 and then visits ever 12 weeks until either they discontinue or the study finishes at Week 60. If the patients discontinue the study early there will be a follow up visit after 30 days of the last visit.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0107
Date of REC Opinion
15 May 2019
REC opinion
Further Information Favourable Opinion