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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 87
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events
研究概览
简要总结
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms.
ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide.
Participants will receive the following for up to 56 weeks:
Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study.
Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B
There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching placebo) 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.
排除标准
- •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.
研究组 & 干预措施
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Elsubrutinib (Drug)
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Upadacitinib (Drug)
Elsubrutinib placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mg
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Placebo for Elsubrutinib (Drug)
Elsubrutinib placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mg
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Upadacitinib (Drug)
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
干预措施: Elsubrutinib (Drug)
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
干预措施: Upadacitinib (Drug)
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Elsubrutinib (Drug)
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Upadacitinib (Drug)
Elsubrutinib 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Elsubrutinib (Drug)
Elsubrutinib 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
干预措施: Placebo for Upadacitinib (Drug)
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
干预措施: Elsubrutinib (Drug)
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
干预措施: Upadacitinib (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events
时间窗: From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.
次要结局
- Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4(Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104)
- Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response(Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104)
- Change From Baseline in Daily Prednisone Dose Over Time(Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104)
- Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104(From Week 56 through Week 104)