A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 97
- 试验地点
- 30
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
详细描述
This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib [ELS] 5 mg, 20 mg, and 60 mg) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has completed Study M16-063
- •Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol
- •Participant is willing and/or able to comply with procedures required in the current study protocol
排除标准
- •Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063)
- •Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug
研究组 & 干预措施
ABBV-105 20 mg/UPA placebo
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
干预措施: Placebo for upadacitinib (Drug)
ABBV-599 in M16-063/ABBV-599 in M16-763
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
干预措施: Elsubrutinib (Drug)
ABBV-599 in M16-063/ABBV-599 in M16-763
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
干预措施: Upadacitinib (Drug)
ABBV-105 60 mg/UPA placebo
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
干预措施: Elsubrutinib (Drug)
ABBV-105 60 mg/UPA placebo
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
干预措施: Placebo for upadacitinib (Drug)
ABBV-105 20 mg/UPA placebo
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
干预措施: Elsubrutinib (Drug)
ABBV-105 5 mg/UPA placebo
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
干预措施: Elsubrutinib (Drug)
ABBV-105 5 mg/UPA placebo
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
干预措施: Placebo for upadacitinib (Drug)
UPA 15 mg/ABBV-105 placebo
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
干预措施: Upadacitinib (Drug)
UPA 15 mg/ABBV-105 placebo
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
干预措施: Placebo for elsubrutinib (Drug)
Placebo in M16-063/ABBV-599 in M16-763
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
干预措施: Elsubrutinib (Drug)
Placebo in M16-063/ABBV-599 in M16-763
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
干预措施: Upadacitinib (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. 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 adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
次要结局
- Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)(Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)(Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria(Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria(Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)
- Change in Morning Stiffness Severity From Baseline of Study M16-063(Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763)