M20-370 Phase 2 ABBV-154 study in PMR pts dependent on GC Tx
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
IRAS ID
301154
Contact name
Nicola Gullick
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2021-000648-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 9 days
Research summary
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.
ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 2 in 5 chance that a participant will be assigned to placebo. Around 200 participants, 50 to 80 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.
The study is compromised of a 52 week double-blind, placebo-controlled period, a follow-up phone call, 30 days after last dose of study drug, and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0031
Date of REC Opinion
16 Mar 2022
REC opinion
Further Information Favourable Opinion