A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis

Study Purpose

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are:

- To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).

- To assess the safety and tolerability of upadacitinib in adult participants with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2).

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	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Study 1: Participant has the clinical diagnosis of ankylosing spondylitis (AS) who meet the modified New York Criteria for AS (Study 1); OR.

- Study 2: Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).

- Study 1 and Study 2: Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.

- Study 1: Participants must have had an inadequate response to biologic disease-modifying antirheumatic drug (bDMARD) therapy.

- Study 2: Participant with prior treatment with bDMARD-therapy is allowed.

Exclusion Criteria:

- Participant must not have been exposed to Janus Kinase (JAK) inhibitor.

- Prior bDMARD therapy has to be washed out.

- Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.

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.	NCT04169373
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	Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Russian Federation, Slovakia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spondyloarthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Study 1: Upadacitinib

Participants will be administered upadacitinib for 104 weeks

Experimental: Study 1: Placebo

Participants will be administered placebo for 14 weeks followed by upadacitinib for 90 weeks

Experimental: Study 2: Upadacitinib

Participants will be administered upadacitinib for 104 weeks

Experimental: Study 2: Placebo

Participants will be administered placebo for 52 weeks followed by upadacitinib for 52 weeks

Interventions

Drug: - Upadacitinib

Upadacitinib is administered as oral tablet

Drug: - Placebo

Placebo for upadacitinib is administered as oral tablet

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.

Flagstaff, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282

Flagstaff, Arizona, 86001-6269

Site Contact

Clinical Trial Finder