A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

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
  Placebo tablet for upadacitinib will be administered orally.

Study Details

This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

Key Dates

Start date

Oct 8, 2018

Status verified

Apr 2021

Primary completion

Mar 26, 2020

Completion

Mar 26, 2020

Study Design

Enrollment

242 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: ELS placebo/UPA placebo
  Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
• Experimental: UPA 15 mg/ELS 60 mg
  15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
• Experimental: ELS 60 mg/UPA placebo
  60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
• Experimental: ELS 20 mg/UPA placebo
  20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
• Experimental: ELS 5 mg/UPA placebo
  5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
• Experimental: UPA 15 mg/ELS placebo
  15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks

Primary Outcome Measure

Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (78)

Find similar trials in Huntsville, AL

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