A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
A Phase 2 Study to Evaluate the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA for the Treatment of Moderate to Severe Upper Facial Lines in Adults
The objective of this Phase 2 study is to assess the safety and efficacy of single treatment of trenibotulinumtoxinE and onabotulibumtoxinA combination in adult participants with moderate to severe upper facial lines. The study has two parts; Part 1 evaluates treatment for glabellar lines.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：ABBVIE CALL CENTER
- 电话号码：844-663-3742
- 邮箱：abbvieclinicaltrials@abbvie.com
学习地点
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Alabama
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Birmingham、Alabama、美国、35205
- 招聘中
- Total Skin and Beauty Dermatology Center /ID# 284360
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Arizona
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Glendale、Arizona、美国、85308
- 招聘中
- Advanced Research Associates - Glendale /ID# 284389
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California
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Newport Beach、California、美国、92663
- 招聘中
- Eye Research Foundation /ID# 284401
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Vista、California、美国、92083
- 招聘中
- Pacific Clinical Innovations /ID# 284406
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Connecticut
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Westport、Connecticut、美国、06880
- 招聘中
- DMR Research - Westport /ID# 286612
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District of Columbia
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Washington D.C.、District of Columbia、美国、20005
- 招聘中
- Sherber+Rad /ID# 286392
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Georgia
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Atlanta、Georgia、美国、30331
- 招聘中
- Atlanta Biomedical Clinical Research /ID# 284411
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Indiana
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Indianapolis、Indiana、美国、46260
- 招聘中
- Laser and Skin Surgery Center of Indiana /ID# 284383
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Louisiana
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Metairie、Louisiana、美国、70006
- 招聘中
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
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New Orleans、Louisiana、美国、70115
- 招聘中
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
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New Orleans、Louisiana、美国、70130
- 招聘中
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
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Maryland
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Hunt Valley、Maryland、美国、21030
- 招聘中
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
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Massachusetts
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Chestnut Hill、Massachusetts、美国、02467
- 招聘中
- Skincare Physicians /ID# 284415
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Michigan
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Clarkston、Michigan、美国、48346
- 招聘中
- Clarkston Dermatology /ID# 284483
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North Carolina
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Wilmington、North Carolina、美国、28403
- 招聘中
- Wilmington Dermatology Center /ID# 284385
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Tennessee
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Nashville、Tennessee、美国、37203
- 招聘中
- Private Practice - Dr. Brian S. Biesman /ID# 284417
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Texas
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Austin、Texas、美国、78746
- 招聘中
- Westlake Dermatology Clinical Research Center /ID# 284374
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College Station、Texas、美国、77845
- 招聘中
- J and S Studies /ID# 285693
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Dallas、Texas、美国、75225
- 招聘中
- Dallas Center for Dermatology and Aesthetics /ID# 284356
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Pflugerville、Texas、美国、78660
- 招聘中
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
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Virginia
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Arlington、Virginia、美国、22209
- 招聘中
- SkinDC /ID# 284403
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- For glabellar lines (GL) indication: participant must have moderate or severe GL at maximum furrow as assessed by both the investigator and participant using the AGLSS at Screening and Baseline (Day 1) visits.
- Participant must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead electrocardiogram (ECG) parameters, clinical laboratory evaluations, and neurological assessment.
- In the investigator's opinion, participant must not have a condition or be in a situation that may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
Exclusion Criteria:
- For GL Indication: Severe GL at rest as assessed by the investigator using the AGLSS at Screening or Baseline (Day 1).
- History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients
- Active infection or dermatological condition at the treatment injection sites.
- Medical condition that may put the subject at increased medical risk with exposure to botulinum toxin, including diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
实验性的：TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
有源比较器：OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
|
安慰剂比较：Placebo
Participants will receive a single treatment of placebo. |
Injection |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
大体时间：Up to Day 150
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to Day 150
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Percentage of Participants Achieving None or Mild on the Investigator-Assessed Allergan Glabellar Lines Severity Scale (AGLSS)
大体时间：Day 7
|
Achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity. |
Day 7
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
大体时间：Day 7
|
Achievement of None or Mild on the subject-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity. |
Day 7
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Duration Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
大体时间：Up to Day 150
|
Duration AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the duration of treatment effect over time. |
Up to Day 150
|
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Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
大体时间：Up to to Day 7
|
Onset AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the rapidity of onset of treatment effect. |
Up to to Day 7
|
合作者和调查者
赞助
调查人员
- 研究主任：ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- M26-312
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 共享时间框架
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 共享访问标准
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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