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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)

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) - M20-186

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49547
Enrollment
6
Registered
2020-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE

Interventions

Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were rece

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subjects will have completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV599 [elsubrutinib/upadacitinib] combination) 2. Subjects must be on stable background treatment for SLE throughout the study. 3. Subjects must understand and voluntarily sign and date an IEC/IRB- approved informed consent 4. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test 5. Female subjects must be either postmenopausal, OR permanently surgically sterile OR practicing at least one protocol-specified method of birth control

Exclusion criteria

Exclusion criteria: 1. Subjects may not have any active, chronic, or recurrent viral or bacterialinfection. 2. Must not require vaccination with any live vaccine during study participation. 3. Must not have a history of any malignancy except for successfully treated Non-Melanoma Skin Cancer (NMSC) or localized carcinoma in-situ (CIS) of the cervix. 4. Must not be a recipient of an organ transplant. 5. Women must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for at least 30 days after the last dose of study drug.

Design outcomes

Secondary

MeasureTime frame
• SLE Responder Index (SRI)-4. • British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA). • Steroid burden, assessed as change from M19-130 Baseline. • Number of mild, moderate or severe flares per patient-year (respectively and overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI flare index (SFI), assessed by number and types of flare per subject compared across treatment groups .—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)