NCT03823378

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib \[ELS\]) and ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).

Detailed description

This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib \[ELS\] 5 mg, 20 mg, and 60 mg) and ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Elsubrutinib	Elsubrutinib capsule will be administered orally.
DRUG	Upadacitinib	Upadacitinib tablet will be administered orally.
DRUG	Placebo for elsubrutinib	Placebo capsule for elsubrutinib will be administered orally.
DRUG	Placebo for upadacitinib	Upadacitinib placebo tablet will be administered orally.

Timeline

• Start date: 2019-05-13
• Primary completion: 2020-09-09
• Completion: 2020-09-09
• First posted: 2019-01-30
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

30 sites across 7 countries: Belgium, Canada, Czechia, Hungary, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study