M20-186 A Phase 2, Long-Term Extension Study in SLE

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  307457

• Contact name

  Ben Parker

• Contact email

  ben.parker@mft.nhs.uk

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2020-001690-72

• Clinicaltrials.gov Identifier

  NCT04451772

• Duration of Study in the UK

  1 years, 5 months, 7 days

• Research 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

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  22/EM/0047

• Date of REC Opinion

  9 Mar 2022

• REC opinion

  Further Information Favourable Opinion