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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: ABBVIE CALL CENTER
- Número de telefone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Recrutamento
- Total Skin and Beauty Dermatology Center /ID# 284360
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Arizona
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Glendale, Arizona, Estados Unidos, 85308
- Recrutamento
- Advanced Research Associates - Glendale /ID# 284389
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California
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Newport Beach, California, Estados Unidos, 92663
- Recrutamento
- Eye Research Foundation /ID# 284401
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Vista, California, Estados Unidos, 92083
- Recrutamento
- Pacific Clinical Innovations /ID# 284406
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Connecticut
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Westport, Connecticut, Estados Unidos, 06880
- Recrutamento
- DMR Research - Westport /ID# 286612
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20005
- Recrutamento
- Sherber+Rad /ID# 286392
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Georgia
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Atlanta, Georgia, Estados Unidos, 30331
- Recrutamento
- Atlanta Biomedical Clinical Research /ID# 284411
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- Recrutamento
- Laser and Skin Surgery Center of Indiana /ID# 284383
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- Recrutamento
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
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New Orleans, Louisiana, Estados Unidos, 70115
- Recrutamento
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
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New Orleans, Louisiana, Estados Unidos, 70130
- Recrutamento
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
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Maryland
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Hunt Valley, Maryland, Estados Unidos, 21030
- Recrutamento
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
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Massachusetts
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Recrutamento
- Skincare Physicians /ID# 284415
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Michigan
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Clarkston, Michigan, Estados Unidos, 48346
- Recrutamento
- Clarkston Dermatology /ID# 284483
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North Carolina
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Wilmington, North Carolina, Estados Unidos, 28403
- Recrutamento
- Wilmington Dermatology Center /ID# 284385
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Private Practice - Dr. Brian S. Biesman /ID# 284417
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Texas
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Austin, Texas, Estados Unidos, 78746
- Recrutamento
- Westlake Dermatology Clinical Research Center /ID# 284374
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College Station, Texas, Estados Unidos, 77845
- Recrutamento
- J and S Studies /ID# 285693
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Dallas, Texas, Estados Unidos, 75225
- Recrutamento
- Dallas Center for Dermatology and Aesthetics /ID# 284356
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Pflugerville, Texas, Estados Unidos, 78660
- Recrutamento
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
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Virginia
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Arlington, Virginia, Estados Unidos, 22209
- Recrutamento
- SkinDC /ID# 284403
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Comparador Ativo: OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
|
Comparador de Placebo: Placebo
Participants will receive a single treatment of placebo. |
Injection |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Prazo: 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)
Prazo: Day 7
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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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Prazo: 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
|
|
Duration Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: ABBVIE INC., AbbVie
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- M26-312
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Critérios de acesso de compartilhamento IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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