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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

NCT03978520•AbbVie

View on ClinicalTrials.gov

Summary

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs 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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant has clinical diagnosis of Systemic Lupus Erythematosus (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 (SLE Disease Activity Index) ≥ 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 Principal Investigator (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.
+2 more criteria

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.

Locations (160)

Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522

Mesa, Arizona, United States

AZ Arthritis and Rheumotology Research, PLLC /ID# 211329

Phoenix, Arizona, United States

AZ Arthritis and Rheumotology Research, PLLC /ID# 214267

Phoenix, Arizona, United States

Arthritis and Rheumatism Associates /ID# 211411

Jonesboro, Arkansas, United States

Wallace Rheumatic Studies Center, LLC /ID# 211600

Beverly Hills, California, United States

Arthritis & Osteo Medical Ctr /ID# 228235

La Palma, California, United States

Valerius Medical Group & Research Center /ID# 211599

Los Alamitos, California, United States

East Bay Rheumatology Medical /ID# 211638

San Leandro, California, United States

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402

Torrance, California, United States

Medvin Clinical Research /ID# 211996

Tujunga, California, United States

Key Dates

Start Date

July 25, 2019

Primary Completion Date

January 19, 2022

Completion Date

July 14, 2022

Last Updated

July 21, 2023

Enrollment

341

ACTUAL participants

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

Elsubrutinib

DRUG

Placebo for elsubrutinib

DRUG

Upadacitinib

DRUG

Placebo for upadacitinib

DRUG

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE4

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Systemic Lupus Erythematosus (SLE)Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

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