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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35205
- 모병
- Total Skin and Beauty Dermatology Center /ID# 284360
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Arizona
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Glendale, Arizona, 미국, 85308
- 모병
- Advanced Research Associates - Glendale /ID# 284389
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California
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Newport Beach, California, 미국, 92663
- 모병
- Eye Research Foundation /ID# 284401
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Vista, California, 미국, 92083
- 모병
- Pacific Clinical Innovations /ID# 284406
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Connecticut
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Westport, Connecticut, 미국, 06880
- 모병
- DMR Research - Westport /ID# 286612
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20005
- 모병
- Sherber+Rad /ID# 286392
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Georgia
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Atlanta, Georgia, 미국, 30331
- 모병
- Atlanta Biomedical Clinical Research /ID# 284411
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Indiana
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Indianapolis, Indiana, 미국, 46260
- 모병
- Laser and Skin Surgery Center of Indiana /ID# 284383
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Louisiana
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Metairie, Louisiana, 미국, 70006
- 모병
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
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New Orleans, Louisiana, 미국, 70115
- 모병
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
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New Orleans, Louisiana, 미국, 70130
- 모병
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
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Maryland
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Hunt Valley, Maryland, 미국, 21030
- 모병
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
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Massachusetts
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Chestnut Hill, Massachusetts, 미국, 02467
- 모병
- Skincare Physicians /ID# 284415
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Michigan
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Clarkston, Michigan, 미국, 48346
- 모병
- Clarkston Dermatology /ID# 284483
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North Carolina
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Wilmington, North Carolina, 미국, 28403
- 모병
- Wilmington Dermatology Center /ID# 284385
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Tennessee
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Nashville, Tennessee, 미국, 37203
- 모병
- Private Practice - Dr. Brian S. Biesman /ID# 284417
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Texas
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Austin, Texas, 미국, 78746
- 모병
- Westlake Dermatology Clinical Research Center /ID# 284374
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College Station, Texas, 미국, 77845
- 모병
- J and S Studies /ID# 285693
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Dallas, Texas, 미국, 75225
- 모병
- Dallas Center for Dermatology and Aesthetics /ID# 284356
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Pflugerville, Texas, 미국, 78660
- 모병
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
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Virginia
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Arlington, Virginia, 미국, 22209
- 모병
- SkinDC /ID# 284403
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
실험적: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
활성 비교기: OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
|
위약 비교기: Placebo
Participants will receive a single treatment of placebo. |
Injection |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
기간: 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)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
기간: 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
기간: Up to Day 150
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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
기간: Up to to Day 7
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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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- M26-312
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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