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

Brief 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 There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventional study

Status:
Enrolling by invitation
Conditions:
Systemic Lupus Erythematosus (SLE)
Enrollment:
260 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-186
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 65 Years.

Inclusion Criteria:

- Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib,
upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching
placebo) and will not have developed any laboratory or clinical discontinuation
criteria as defined in that study.

- On stable background treatment for SLE throughout the study.

Exclusion Criteria:

- Active, chronic, or recurrent viral, or bacterial infection.

- Active tuberculosis (TB)

- History of gastrointestinal (GI) perforation, diverticulitis, or a significantly
increased risk for GI perforation per investigator assessment.

- Participant require vaccination with live vaccine during study participation.

All the cities where the clinical studies are located

Toronto - M5T 2S8

Ontario

More information about this study

clinicaltrials.gov