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临床试验/NCT04972968
NCT04972968终止2 期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

AbbVie117 个研究点 分布在 8 个国家目标入组 181 人开始时间: 2021年9月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
181
试验地点
117
主要终点
Time to Flare

研究概览

简要总结

Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.

The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during 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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
  • Must have had at least 2 episodes of unequivocal PMR flare.
  • Must be on a stable dose of prednisone.
  • Must be willing to follow the protocol-defined glucocorticoid tapering regimen.

排除标准

  • Have been treated with a prior TNF antagonist.
  • Current use of immunomodulators other than prednisone and hydroxychloroquine.

研究组 & 干预措施

ABBV-154 Dose A

Experimental

Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: ABBV-154 (Drug)

ABBV-154 Dose A

Experimental

Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: Glucocorticoid (Drug)

ABBV-154 Dose B

Experimental

Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: ABBV-154 (Drug)

ABBV-154 Dose B

Experimental

Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: Glucocorticoid (Drug)

ABBV-154 Dose C

Experimental

Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: ABBV-154 (Drug)

ABBV-154 Dose C

Experimental

Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: Glucocorticoid (Drug)

Placebo

Placebo Comparator

Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

干预措施: Glucocorticoid (Drug)

结局指标

主要结局

Time to Flare

时间窗: From first dose of study drug to Week 52

Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.

次要结局

  • Percentage of Participants Achieving Flare-Free State(Up to Week 24)
  • Cumulative Glucocorticoid Dose(Week 24)
  • Change From Baseline in Glucocorticoid Dose(Week 24)

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

研究点 (117)

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