A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Study Purpose

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 remission in Period 1.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of giant cell arteritis (GCA) according to the following criteria: - History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity C-reactive protein (hsCRP)/CRP >=1.0 mg/dL.

- Presence of at least one of the following: Unequivocal cranial symptoms of GCA or Unequivocal symptoms of polymyalgia rheumatica (PMR) - Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET).

- 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: - Anakinra within 1 week of study start.

- Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate within 4 weeks of study start.

- Oral corticosteroid (CS) for conditions other than GCA within 4 week of study start, or intravenous CS within 4 weeks of study start.

- Greater than or equal to 8 weeks for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure.

- Cell-depleting agents or alkylating agents including cyclophosphamide within 6 months of 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03725202
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AbbVie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	ABBVIE INC.
Principal Investigator Affiliation	AbbVie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Giant Cell Arteritis (GCA)
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Arm A

Upadacitinib dose A administered daily + 26-week CS taper regimen

Experimental: Arm B

Upadacitinib dose B administered daily + 26-week CS taper regimen

Placebo Comparator: Arm C

Placebo administered daily + 52-week CS taper regimen

Interventions

Drug: - Upadacitinib

It will be administered orally.

Drug: - Corticosteroid (CS)

It will be administered orally.

Other: - Placebo

It will be administered orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rheum Assoc of North Alabama /ID# 168668, Huntsville, Alabama

Status

Completed

Address

Rheum Assoc of North Alabama /ID# 168668

Huntsville, Alabama, 35801

Site Contact

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