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

  • STATUS
    Recruiting
Updated on 23 November 2020
cyclosporine
prednisone

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
Clinical Study IdentifierTX230583
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, 18 - 65 years of age
Must have at least one of the following: ANA+ (≥ 1:80), anti-dsDNA+, or anti-Smith+ Background tx, stable for 30 days at Baseline, with antimalarial(s), prednisone (≤ 20 mg), AZA (≤ 150 mg), CellCept (≤ 2 g), LEF (≤ 20 mg), cyclosporine, tacrolimus, and/or MTX (≤ 20 mg). The combination of background tx with antimalarial(s) and/or prednisone (or equivalent) and a single, but not multiple, add'l immunosuppressant is permitted

Exclusion Criteria

Excl. active lupus nephritis (Class IV or >1g/d proteinuria) or have undergone induction therapy within the last 6 mos
Excl. a history of any malignancy except for successfully treated non-melanoma skin cancer or carcinoma in-situ of the cervix
Excl. any conditions that could interfere with drug absorption including but not limited to short bowel syndrome
Excl. recipients of an organ transplant
No hx of clinically significant medical conditions or any other reason that in the opinion of PI would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug
Must not be using IV or IM corticosteroids ≥40 mg prednisone-equivalent bolus within 30 days of planned rand. Must not have been treated with IA, IM, IV, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 wks prior to the first dose of study drug
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