A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
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- STATUS
- Recruiting
Summary
The purpose of this study is to see if the study drugs, ABBV-105, upadacitinib (ABT-494), or both ABBV-105 and upadacitinib (ABT-494) in combination (ABBV-599) are safe, tolerable, and effective in treating your moderately to severely active systemic lupus erythematosus (SLE).
Description
Subjects must be naïve or have disc. the following prior to the first dose of study drug per the applicable washout period below or should be at least 5 times the mean terminal elimination half-life of a drug:
- Greater than or equal to 6 mos for Plasmapheresis
- Greater than or equal to 3 mos for Benlysta
- Greater than or equal to 3 mos for cyclophosphamide
- Greater than or equal to 1 year for rituximab OR Greater than or equal to 6 mos if B cells have returned to Greater than or equal to 50 B cells per microliter Excl. prior exposure Greater than or equal to 14 days or more or prior intolerance to a JAK inhibitor. The washout period for JAK inhibitors prior to the first dose of study drug is Greater than or equal to 30 days.
- Must discontinue all high-potency opiates at least 1 wk and traditional Chinese medicine for at least 30 days prior to the
- First dose of study drug.
- Must not have recv’d any live vaccine Greater than or equal to 30 days prior to the first dose of study drug.
Details
| Condition | SYSTEMIC LUPUS ERYTHEMATOSUS, Systemic Lupus Erythematosus |
|---|---|
| Clinical Study Identifier | TX230583 |
| Last Modified on | 23 November 2020 |
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