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[M20-186] 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] 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)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210119
Enrollment
260
Registered
2021-05-28
Start date
2021-04-27
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Systemic Lupus Erythematosus

Interventions

Drug: Elsubrutinib Oral
Capsule Other Name: ABBV-105 Drug: Placebo for Elsubrutinib Oral
Capsule Drug: Upadacitinib Oral
Tablet Other Names:ABT-494, RINVOQ Drug: Placebo for Upadacitinib Oral
Tablet

Sponsors

Otani Tetsuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination) 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

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.

Design outcomes

Primary

MeasureTime frame
Number of Participants With Adverse Events [ Time Frame: Through Week 108 ]—

Secondary

MeasureTime frame
1. Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 [ Time Frame: Through Week 104 ] 2. Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) [ Time Frame: Through Week 104 ] 3. Change in Steroid Burden [ Time Frame: Baseline of M19-130 (Week 0) Through Week 104 ] 4. Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI) [ Time Frame: Through Week 104 ]—

Countries

Argentina, Bulgaria, China, Germany, Hungary, Japan, Mexico, Netherlands, Poland, Puerto Rico, Spain, Taiwan, United States

Contacts

Public ContactContact for Patients and HCP

AbbVie. G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026