Phase 2
Completed N=341
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)
Source: ClinicalTrials.gov NCT03978520 ↗Enrolled (actual)
341
Serious AEs
14.4%
Results posted
Jul 2023
Primary outcomePrimary: Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24 — 37.3; 48.5; 54.8 percentage of participants — p==0.081
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24 |
37.3; 48.5; 54.8 | =0.081 |
| SECONDARY Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24 |
38.7; 54.4; 56.5 | =0.013 sig |
| SECONDARY Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24 |
42.7; 54.4; 58.1 | =0.049 sig |
| SECONDARY Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24 |
13.3; 30.9; 45.2 | =0.007 sig |
| SECONDARY Change From Baseline in Daily Prednisone Dose at Week 24 |
-0.65; -0.45; -0.62 | =0.710 |
| SECONDARY Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24 |
2.45; 1.39; 1.76; 0.36; 0.26; 0.10 | =0.002 sig |
Eligibility Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03978520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.