M16-063 Phase 2 study investigating ABBV-105/ ABBV-599 in RA patients
Research type
Research Study
Full title
A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs
IRAS ID
253697
Contact name
Peter Taylor
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2018-000666-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 22 days
Research summary
This 12 week phase 2 blinded study is investigating whether ABBV-105 and ABBV-599 improves joint swelling and pain 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 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.
The screening period is 35 days. Patients who are eligible for the study will be randomly assigned one of six treatment groups in a ratio of 3:2:2:2:2:1. 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. Group 5 will receive Upadacitinib with ABBV-105 placebo and Group 6 will be allocated ABBV-105 and Updacitinib placebo. There is the option for patients in Group 6 to receive ABBV-599 should they complete the study and enter the long term extension study (M16-763). Patients take four tablets daily to maintain the blinded nature of the study for up to 12 weeks. Patients will attend visits at Baseline, Week 2, Week 4, Week 8 and Week 12. If the patients complete Week 12 or if a patient discontinues 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
18/EM/0366
Date of REC Opinion
17 Dec 2018
REC opinion
Further Information Favourable Opinion