deltatrials
Completed PHASE2 INTERVENTIONAL 6-arm NCT04451772

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

A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

Sponsor: AbbVie

Conditions Systemic Lupus Erythematosus (SLE)
Interventions Elsubrutinib Placebo for Elsubrutinib Placebo for Upadacitinib Upadacitinib
Updated 18 times since 2020 Last updated: Dec 19, 2024 Started: Jul 27, 2020 Primary completion: Jan 3, 2024 Completion: Jan 3, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Systemic Lupus Erythematosus (SLE) and is currently completed. AbbVie leads this study, which shows 18 recorded versions since 2020 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~May 2022 · 4 months · monthly snapshot~May 2022 – ~Dec 2022 · 7 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Feb 2024 · 12 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE2

  3. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 13 earlier versions

  1. Feb 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2

  3. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: Enrolling By Invitation → Active Not Recruiting

  4. May 2022 — Dec 2022 [monthly]

    Enrolling By Invitation PHASE2

  5. Jan 2022 — May 2022 [monthly]

    Enrolling By Invitation PHASE2

  6. Dec 2021 — Jan 2022 [monthly]

    Enrolling By Invitation PHASE2

  7. Sep 2021 — Dec 2021 [monthly]

    Enrolling By Invitation PHASE2

  8. Jan 2021 — Sep 2021 [monthly]

    Enrolling By Invitation PHASE2

  9. Nov 2020 — Jan 2021 [monthly]

    Enrolling By Invitation PHASE2

    Status: Recruiting → Enrolling By Invitation

  10. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

  11. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

  12. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  13. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AbbVie
Data source: AbbVie

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

A Coruña, Spain , Asahikawa-shi, Japan , Aurora, United States , Austin, United States , Aventura, United States , Barranquilla, Colombia , Beijing, China , Berlin, Germany , Beverly Hills, United States , Bilbao, Spain and 69 more locations