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Clinical Trials List

Protocol NumberM19-130
NCT Number(ClinicalTrials.gov Identfier)NCT03978520
Completed

2019-07-19 - 2022-01-01

Phase II

Recruiting6

ICD-10M32.0

Drug-induced systemic lupus erythematosus

ICD-10M32.10

Systemic lupus erythematosus, organ or system involvement unspecified

ICD-10M32.11

Endocarditis in systemic lupus erythematosus

ICD-10M32.12

Pericarditis in systemic lupus erythematosus

ICD-10M32.13

Lung involvement in systemic lupus erythematosus

ICD-10M32.14

Glomerular disease in systemic lupus erythematosus

ICD-10M32.15

Tubulo-interstitial nephropathy in systemic lupus erythematosus

ICD-10M32.19

Other organ or system involvement in systemic lupus erythematosus

ICD-10M32.8

Other forms of systemic lupus erythematosus

ICD-10M32.9

Systemic lupus erythematosus, unspecified

ICD-9710.0

Systemic lupus erythematosus

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

  • Trial Applicant

    AbbVie

  • Sponsor

    ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH (SWITZERLAND)

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/18

Investigators and Locations

Principal Investigator Joung-Liang Lan 風濕免疫科
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIEH-YU SHEN Division of Rheumatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator WEN-NAN HUANG Division of Rheumatology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Sheng Chen Division of Rheumatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ching Chang 風濕免疫科
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fu Kuo
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Systemic Lupus Erythematosus (SLE)

Objectives

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.

Test Drug

NA

Active Ingredient

NA

Dosage Form

NA

Dosage

NA

Endpoints

Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:

≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA])
No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
Baseline, Week 24

Inclution 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.
Must be on background treatment, stable for 30 days prior to 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.

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    325 participants

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