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

JRCT ID: jRCT2041210052

Registered date:16/08/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Rheumatiod Arthritis
• Date of first enrollment: 10/09/2021
• Target sample size: 425
• Countries of recruitment: Australia,Japan,Austria,Japan,Canada,Japan,Czech,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Isreal,Japan,Italy,Japan,Holland,Japan,New Zealand,Japan,Poland,Japan,Russia,Japan,Slovakia,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,Ukraine,Japan,England,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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 long term extension (LTE) period.

Experimental: Dose B of ABBV-154
Participants in this group will receive dose B of ABBV-154 SC eow for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

Experimental: Dose C of ABBV-154 EOW
Participants in this group will receive dose C of ABBV-154 SC eow for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

Experimental: Dose C of ABBV-154 E4W
Participants in this group will receive dose C of ABBV-154 SC every 4 weeks (e4w) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

Experimental: Placebo
Participants in this group will receive placebo SC eow for 12 weeks in the placebo-controlled period and will be re-randomized in 1:1 ratio to receive ABBV-154 dose B or C respectively SC eow for 66 weeks in the LTE period.

Outcome(s)

• Primary Outcome: Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response [ Time Frame: At 12 weeks ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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).

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

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT04888585