NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210119

Registered date:28/05/2021

[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)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSystemic Lupus Erythematosus
Date of first enrollment17/07/2020
Target sample size260
Countries of recruitmentArgentina,Bulgaria,China,Germany,Hungary,Mexico,Netherlands,Poland,Puerto Rico,Spain,Taiwan,United States,Japan
Study typeInterventional
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 OutcomeNumber of Participants With Adverse Events [ Time Frame: Through Week 108 ]
Secondary Outcome1. 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
GenderBoth
Include criteriaCompleted 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 criteriaActive, 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

Contact

Public contact
Name Contact for Patients and HCP
Address 3-1-21 Shibaura, Minato-ku Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie. G.K.
Scientific contact
Name Hayato Yamazaki
Address 3-1-21 Shibaura, Minato-ku Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K.