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Clinical Trials List

Protocol NumberM20-186

NCT Number(ClinicalTrials.gov Identfier)NCT04451772

Completed

2020-07-31 - 2024-02-06

Phase II

Not yet recruiting3

Recruiting3

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, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

Sponsor

AbbVie
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Joung-Liang Lan 無

China Medical University Hospital

Co-Principal Investigator

黃建中無
Po-Hao Huang 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fu Kuo 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator WEN-NAN HUANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wei-Sheng Chen 無

Taipei Veterans General Hospital

Co-Principal Investigator

Chien-Chih Lai 無
Chang-Youh Tsai 無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHIEH-YU SHEN 無

National Taiwan University 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

Tzn-Min Lin 風濕免疫科

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Moderately to Severely Active Systemic Lupus Erythematosus(SLE)

Objectives

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 146 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Test Drug

Elsubrutinib / Upadacitinib

Active Ingredient

Elsubrutinib (ABBV-105)
Upadacitinib (ABT-494)
Upadacitinib (ABT-494)

Dosage Form

capsule/tablet

Dosage

20mg/cap
15mg/tab
30mg/tab

Endpoints

Primary Outcome Measures :
Number of Participants With Adverse Events [ Time Frame: Through Week 108 ]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Secondary Outcome Measures :
Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 [ Time Frame: Through Week 104 ]
SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.

Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) [ Time Frame: Through Week 104 ]
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.

Change in Steroid Burden [ Time Frame: Baseline of M19-130 (Week 0) Through Week 104 ]
Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.

Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI) [ Time Frame: Through Week 104 ]
SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.

Inclution Criteria

Inclusion Criteria:

Completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
On stable background treatment for SLE throughout the study.

Exclusion Criteria

Exclusion Criteria:

Active, chronic, or recurrent viral, or bacterial infection.
Active tuberculosis (TB)
History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
Participant require vaccination with live vaccine during study participation.

The Estimated Number of Participants

Taiwan

20 participants
Global

260 participants