A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Study Purpose

The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 vs.#46;placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

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 - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participant has clinical diagnosis of SLE at least 24 weeks prior to screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.

- At Screening, must have at least one of the following: - antinuclear antibody(ANA)+ (titer >= 1:80).

- anti-dsDNA+.

- anti-Smith+.

- SLEDAI-2K >= 6 despite background therapy as reported and independently adjudicated (clinical score >= 4, excluding lupus headache and/or organic brain syndrome) at Screening.

- If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.

- If participant has rash and PI considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.

- Score must be re-confirmed at the Baseline visit.

- Physician's Global Assessment (PhGA) >= 1 during screening period.

- Must be on background treatment, stable for 30 days, at Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (<=20 mg), azathioprine (<= 150 mg), mycophenolate (<2 g), leflunomide (<=20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (<=20 mg).

- No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.

Exclusion Criteria:

- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

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.	NCT03978520
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 2
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, Bulgaria, Canada, China, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus (SLE)
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Group 1: Upadacitinib and Elsubrutinib

Participants will be administered with elsubrutinib dose A and upadacitinib dose A.

Experimental: Group 2: Upadacitinib and Elsubrutinib

Participants will be administered with elsubrutinib dose A and upadacitinib dose B.

Experimental: Group 3: Elsubrutinib and Placebo for Updadacitinib

Participants will be administered with elsubrutinib dose A and placebo for upadacitinib.

Experimental: Group 4: Upadacitinib and Placebo for Elsubrutinib

Participants will be administered with placebo for elsubrutinib and upadacitinib dose A.

Experimental: Group 5: Placebo for Elsubrutinib and Placebo for Upadacitinib

Participants will be administered with placebo for elsubrutinib and placebo for upadacitinib.

Interventions

Drug: - Elsubrutinib

Capsule; Oral

Drug: - Placebo for Elsubrutinib

Capsule; Oral

Drug: - Upadacitinib

Tablet; Oral

Drug: - Placebo for upadacitinib

Tablet; Oral

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.

Mesa, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522

Mesa, Arizona, 85210-6871

Site Contact

Clinical Trial Finder