[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)

JRCT ID: jRCT2031210119

Registered date:28/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 27/04/2021
• Target sample size: 260
• Countries of recruitment: Argentina,Japan,Bulgaria,Japan,China,Japan,Germany,Japan,Hungary,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Puerto Rico,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Number of Participants With Adverse Events [ Time Frame: Through Week 108 ]

Secondary Outcome

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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamazaki Hayato