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
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
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 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 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 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).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Inclusion Criteria:
Exclusion Criteria:
Boca Raton, Florida 33486, United States
Tupelo, Mississippi 38801-4949, United States
Summerville, South Carolina 29486-7887, United States
Veszprém, 8200, Hungary
Siena, 53100, Italy
Udine, 33100, Italy
Yotsukaido-shi, Chiba 284-0003, Japan
Sanuki-shi, Kagawa-ken 769-2393, Japan
Kuwana-shi, Mie-ken 511-0061, Japan
Beppu-shi, Oita Prefecture 874-0838, Japan
Takatsuki-shi, Osaka 569-8686, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Grafotn, Auckland 1010, New Zealand
Christchurch Central, 8011, New Zealand
Poznan, Greater Poland Voivodeship 61-545, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
Wroclaw, Lower Silesian Voivodeship 53-224, Poland
Bialystok, Podlaskie Voivodeship 15-707, Poland
Santiago de Compostela, A Coruna 15706, Spain
San Cristóbal de La Laguna, Santa Cruz De Tenerife 38320, Spain
London, London, City of NW3 2QG, United Kingdom
Norwich, Norfolk NR4 7UY, United Kingdom