Phase 2
N=185
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Systemic Lupus Erythematosus (SLE)
Bottom Line
View on ClinicalTrials.gov: NCT04451772 ↗Enrolled (actual)
185
Serious AEs
8.6%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events — 34; 31; 30; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elsubrutinib (Drug); Placebo for Elsubrutinib (Drug); Upadacitinib (Drug); Placebo for Upadacitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events |
34; 31; 30; 11; 11; 7 | — |
| SECONDARY Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 |
71.1; 76.1; 54.3; 70.5; 75.6; 58.8 | — |
| SECONDARY Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response |
73.3; 67.4; 60.0; 75.0; 84.4; 55.9 | — |
| SECONDARY Change From Baseline in Daily Prednisone Dose Over Time |
-3.9; -3.5; -4.9; -4.2; -3.7; -5.0 | — |
| SECONDARY Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104 |
0.62; 1.41; 1.39; 0.00; 0.04; 0.17 | — |
Summary
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 100 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.
Eligibility Criteria
Inclusion Criteria
- Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching placebo) 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
- 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.
Data sourced from ClinicalTrials.gov (NCT04451772). 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.