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Elsubrutinib and Upadacitinib Extension in SLE
NCT04451772Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2020
- Primary completion
- Jan 2024
- Countries
- 18
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Conditions
- systemic lupus erythematosus (SLE)
01
Overview
Phase 2, randomised, double-blind trial of elsubrutinib and upadacitinib in systemic lupus erythematosus (SLE) (6 arms), sponsored by AbbVie Inc. Primary endpoint: Number of Participants With Treatment-Emergent Adverse Events up to 442 days. Started Jul 2020; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
ABBV-599 High Dose
Elsubrutinib 60 mg + Upadacitinib 30 mg (Continued)
Upadacitinib 30 mg
Upadacitinib 30 mg + Placebo (Continued)
Placebo -> ABBV-599 High Dose
Switch from Placebo to Elsubrutinib 60 mg + Upadacitinib 30 mg
ABBV-599 Low Dose
Elsubrutinib 60 mg + Upadacitinib 15 mg (Continued)
Elsubrutinib 60 mg
Elsubrutinib 60 mg + Placebo (Continued)
Placebo -> ABBV-599 Low Dose
Switch from Placebo to Elsubrutinib 60 mg + Upadacitinib 15 mg
03
Who it enrols
Adults with moderately to severely active SLE who completed the M19-130 Phase 2 RCT and are on stable background treatment.
04
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events
Secondary
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Change From Baseline in Daily Prednisone Dose Over Time
Number of Flares Per Patient-year by SELENA-SLEDAI Flare Index
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