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

2019-07-04 - 2022-05-31

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 Elsubrutinib 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

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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 Chang-Fu Kuo Division of Rheumatology
Linkou Chang Gung Medical Foundation

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 CHIEH-YU SHEN Division of Rheumatology
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

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Systemic Lupus Erythematosus (SLE)

Objectives

The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 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

Elsubrutinib, Upadacitinib

Active Ingredient

Elsubrutinib
Upadacitinib

Dosage Form

capsule
tablet

Dosage

20mg
15mg、30mg

Endpoints

Efficacy Endpoints
Primary Endpoint:
1. 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 ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score without worsening of the overall condition (no worsening in Physician's Global Assessment [PhGA], < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group ([BILAG]) A or > 1 new BILAG B).

Secondary Endpoints (for efficacy, at all visits unless otherwise noted):
1. SRI-4 (without ≤ 10 mg prednisone equivalent QD requirement)
2. SRI-5, -6, -7, -8 (and steroid dose ≤ 10 mg prednisone equivalent QD at Weeks 24 and 48; without ≤ 10 mg prednisone equivalent QD requirement at all other visits)
3. BILAG-Based Combined Lupus Assessment (BICLA)
4. Lupus Low Disease Activity State (LLDAS)
5. ≥ 4-point decrease in SLEDAI-2K from Baseline
6. Steroid burden, assessed as change from Baseline
7. Number of mild, moderate, or severe flares per patient-year (respectively and overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index (SFI), assessed by number and types of flare per subject compared across treatment arms
8. Time to first flare by SELENA SFI after first study drug administration up to Week 24 and Week 48
9. Achievement of 50% reduction of tender or swollen lupus joints defined as ≥ 50% decrease in either tender or swollen joints (of those starting with total ≥ 6 affected joints)
10. Achievement of 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score (of those starting with CLASI ≥ 10)
11. Change in SLEDAI-2K from Baseline
12. Change in BILAG from Baseline
13. Change in PhGA from Baseline
14. Change in Patient Global Assessment (PtGA) from Baseline
15. Change from Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) at Weeks 2, 12, 24, and 48
16. Change from Baseline in 36-Item Short Form Health Survey (SF-36) at Weeks 2, 12, 24, and 48
17. Change from Baseline Lupus Quality of Life questionnaire (LupusQoL) at Weeks 2, 12, 24, and 48
18. Change from Baseline Pain Numerical Rating Scale (NRS) at Weeks 2, 12, 24, and 48

Safety Endpoints
Routine safety evaluations include AE monitoring, physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration.

Inclution 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

For those who didn't meet the inclusion criteria listed above will be excluded

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    participants

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