[M20-466] Moderate to Severe Rheumatoid Arthritis: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154

[M20-466] A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210052

Enrollment

425

Registered

2021-08-16

Start date

2021-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatiod Arthritis

Interventions

Experimental: Dose A of ABBV-154 Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 12 weeks in the placebo-controlled period and 66 weeks in the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: --Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA. --Participant has 6 swollen joints (based on 66 joint count) and 6 tender joints (based on 68 joint count) at baseline. --Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA. --Participants must be on stable dose of methotrexate (MTX).

Exclusion criteria

Exclusion criteria: --Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response [ Time Frame: At 12 weeks ]	—

Countries

Australia, Austria, Canada, Czech, England, France, Germany, Greece, Holland, Hungary, Isreal, Italy, Japan, New Zealand, Poland, Russia, Slovakia, South Korea, Spain, Taiwan, Turkey, Ukraine, United States

Contacts

Public ContactContact for Patients and HCP

AbbVie. G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026