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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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 facts

Study ID

NCT03682705

Run by

AbbVie

People needed

242

Starts

2018-10-08

Expected to finish

2020-03-26

Last updated by the study team

2021-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA
• Participant meets the following minimum disease activity criteria:
• ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
• High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening Visit
• Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration
• Participants must have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug
• Participants must have discontinued all bDMARDs prior to the first dose of study drug

You may not qualify if…

• Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the first dose of study drug.

Where it is running

• AZ Arthritis & Rheum Research /ID# 167446 — Mesa, Arizona, United States
• SunValley Arthritis Center, Lt /ID# 213073 — Peoria, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 167448 — Phoenix, Arizona, United States
• St. Joseph Heritage Healthcare /ID# 167379 — Fullerton, California, United States
• Purushotham, Akther & Roshan K /ID# 168121 — La Mesa, California, United States
• Valerius Medical Group /ID# 168123 — Los Alamitos, California, United States
• Sierra Rheumatology /ID# 167976 — Roseville, California, United States
• Rheumatology Center of San Diego /ID# 170690 — San Diego, California, United States
• Iraj Sabahi Research, Inc /ID# 201923 — Turlock, California, United States
• Inland Rheum Clin Trials Inc. /ID# 167459 — Upland, California, United States
• Medvin Clinical Research /ID# 205731 — Whittier, California, United States
• Rheumatology Consultants of De /ID# 208238 — Lewes, Delaware, United States
• Bay Area Arthritis and Osteo /ID# 208111 — Brandon, Florida, United States
• Clinical Res of West FL, Inc. /ID# 167462 — Clearwater, Florida, United States
• Omega Research Maitland, LLC /ID# 167376 — DeBary, Florida, United States
• Riverside Clinical Research /ID# 167982 — Edgewater, Florida, United States
• Lakes Research, LLC /ID# 170660 — Miami, Florida, United States
• Kendall South Medical Center, Inc. /ID# 206857 — Miami, Florida, United States
• Medallion Clinical Research Institute, LLC /ID# 201710 — Naples, Florida, United States
• Rheum Assoc of Central FL /ID# 170858 — Orlando, Florida, United States
• HMD Research LLC /ID# 208381 — Orlando, Florida, United States
• International Medical Research - Ormond /ID# 170864 — Ormond Beach, Florida, United States
• Millennium Research /ID# 167453 — Ormond Beach, Florida, United States
• Arthritis Center, Inc. /ID# 170695 — Palm Harbor, Florida, United States
• Rheum Assoc of North Alabama /ID# 167382 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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