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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)

Otani Tetsuya

AbbVie G.K.

3-1-21 Shibaura, Minato-ku

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Complete

July. 17, 2020

Interventional

randomized controlled trial

double blind

uncontrolled control

parallel assignment

treatment purpose

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.

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.

Both

Systemic Lupus Erythematosus

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

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

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 ]

+81-263-35-4600

Dec. 16, 2020

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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