drugset / Trial / NCT03823378

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

NCT03823378 ↗

Phase 2 Terminated 97 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2019-05-13
Primary completion
2020-09-09
Completion
2020-09-09

Outcome

Outcome not reported

Stopped: “Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Elsubrutinib Small molecule 5 mg Oral
Subject Elsubrutinib Small molecule 20 mg Oral
Subject Elsubrutinib Small molecule 60 mg Oral
Subject Upadacitinib Small molecule 15 mg Oral

Indications