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

Sponsor
AbbVie
Study ID
NCT03823378
Phase
PHASE2
Status
Terminated

Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elsubrutinib — DRUG
    Elsubrutinib capsule will be administered orally.
  • Upadacitinib — DRUG
    Upadacitinib tablet will be administered orally.
  • Placebo for elsubrutinib — DRUG
    Placebo capsule for elsubrutinib will be administered orally.
  • Placebo for upadacitinib — DRUG
    Upadacitinib placebo tablet will be administered orally.

Study Details

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).

Key Dates

Start date
May 13, 2019
Status verified
Aug 2021
Primary completion
Sep 9, 2020
Completion
Sep 9, 2020

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ABBV-599 in M16-063/ABBV-599 in M16-763
    60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
  • Experimental: ABBV-105 60 mg/UPA placebo
    60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
  • Experimental: ABBV-105 20 mg/UPA placebo
    20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
  • Experimental: ABBV-105 5 mg/UPA placebo
    5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
  • Experimental: UPA 15 mg/ABBV-105 placebo
    15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
  • Experimental: Placebo in M16-063/ABBV-599 in M16-763
    Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks ]

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