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)
CompletedPhase 2Results postedLast updated 21 July 2023
What this trial tests
Phase 2 trial testing Elsubrutinib in Systemic Lupus Erythematosus (SLE) in 341 participants. Completed in 14 July 2022.
Adults 18 to 65, any sex, with Systemic Lupus Erythematosus (SLE). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24Primary· Baseline, 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 indicati
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
37.3
26.4 – 48.3
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
48.5
36.7 – 60.4
Elsubrutinib Placebo/Upadacitinib 30 mg
54.8
42.5 – 67.2
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24Secondary· Baseline, 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 indicati
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
38.7
27.6 – 49.7
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
54.4
42.6 – 66.2
Elsubrutinib Placebo/Upadacitinib 30 mg
56.5
44.1 – 68.8
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24Secondary· Baseline, Week 24
BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \[PhGA\], \< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
42.7
31.5 – 53.9
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
54.4
42.6 – 66.2
Elsubrutinib Placebo/Upadacitinib 30 mg
58.1
45.8 – 70.3
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24Secondary· Baseline, Week 24
LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
13.3
5.6 – 21.0
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
30.9
19.9 – 41.9
Elsubrutinib Placebo/Upadacitinib 30 mg
45.2
32.8 – 57.5
Change From Baseline in Daily Prednisone Dose at Week 24Secondary· From Baseline to Week 24
Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
-0.65
-1.57 – 0.28
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
-0.45
-1.38 – 0.48
Elsubrutinib Placebo/Upadacitinib 30 mg
-0.62
-1.60 – 0.36
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24Secondary· From Baseline to Week 24
The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Mild/Moderate
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
2.45
1.92 – 2.99
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
1.39
0.97 – 1.81
Elsubrutinib Placebo/Upadacitinib 30 mg
1.76
1.28 – 2.25
Severe
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
0.36
0.16 – 0.56
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
0.26
0.08 – 0.44
Elsubrutinib Placebo/Upadacitinib 30 mg
0.10
-0.01 – 0.22
Overall
Group
Value
95% CI
Elsubrutinib Placebo/Upadacitinib Placebo
2.81
2.24 – 3.38
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
1.65
1.20 – 2.10
Elsubrutinib Placebo/Upadacitinib 30 mg
1.87
1.37 – 2.36
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Elsubrutinib Placebo/Upadacitinib Placebo
Serious: 13/75 (17%)
Deaths: 0/75
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04451772 — A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-59
· Phase 2
· completed
NCT03823378 — A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combinatio
· Phase 2
· terminated
NCT03682705 — A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combinati
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 21 July 2023
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