A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.
Inclusion Criteria:
Diagnosis of giant cell arteritis (GCA) according to the following criteria:
Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
Participants must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily (QD) at Baseline.
Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen.
Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.
Exclusion Criteria:
Prior exposure to any Janus Kinase (JAK) inhibitor.
Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:
Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
Female who is pregnant, breastfeeding, or considering pregnancy during the study.
Glendale, Arizona 85306-9802, United States
Danbury, Connecticut 06810-5038, United States
Boca Raton, Florida 33486, United States
Grand Blanc, Michigan 48439, United States
Summerville, South Carolina 29486-7887, United States
Colleyville, Texas 76034, United States
Yvoir, Namur 5530, Belgium
Edmonton, Alberta T6G 2B7, Canada
Udine, 33100, Italy
Nagoya, Aichi-ken 455-8530, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Tomigusuku-shi, Okinawa 901-0243, Japan
Sakai-shi, Osaka 593-8304, Japan
Shimotsuke-shi, Tochigi 329-0431, Japan
Chuo-ku, Tokyo 104-8560, Japan
Grafotn, Auckland 1010, New Zealand
Christchurch Central, 8011, New Zealand
Vila Nova de Gaia, Porto District 4434-502, Portugal
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Moscow, Moscow Oblast 129110, Russia
San Cristóbal de La Laguna, Santa Cruz De Tenerife 38320, Spain
Basel Town, Canton of Basel-City 4031, Switzerland
Liverpool, L9 7AL, United Kingdom