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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Reclutamiento
- Total Skin and Beauty Dermatology Center /ID# 284360
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Arizona
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Glendale, Arizona, Estados Unidos, 85308
- Reclutamiento
- Advanced Research Associates - Glendale /ID# 284389
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California
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Newport Beach, California, Estados Unidos, 92663
- Reclutamiento
- Eye Research Foundation /ID# 284401
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Vista, California, Estados Unidos, 92083
- Reclutamiento
- Pacific Clinical Innovations /ID# 284406
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Connecticut
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Westport, Connecticut, Estados Unidos, 06880
- Reclutamiento
- 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
- Reclutamiento
- Sherber+Rad /ID# 286392
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Georgia
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Atlanta, Georgia, Estados Unidos, 30331
- Reclutamiento
- Atlanta Biomedical Clinical Research /ID# 284411
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- Reclutamiento
- Laser and Skin Surgery Center of Indiana /ID# 284383
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- Reclutamiento
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
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New Orleans, Louisiana, Estados Unidos, 70115
- Reclutamiento
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
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New Orleans, Louisiana, Estados Unidos, 70130
- Reclutamiento
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
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Maryland
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Hunt Valley, Maryland, Estados Unidos, 21030
- Reclutamiento
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
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Massachusetts
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Reclutamiento
- Skincare Physicians /ID# 284415
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Michigan
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Clarkston, Michigan, Estados Unidos, 48346
- Reclutamiento
- Clarkston Dermatology /ID# 284483
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North Carolina
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Wilmington, North Carolina, Estados Unidos, 28403
- Reclutamiento
- Wilmington Dermatology Center /ID# 284385
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Private Practice - Dr. Brian S. Biesman /ID# 284417
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Texas
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Austin, Texas, Estados Unidos, 78746
- Reclutamiento
- Westlake Dermatology Clinical Research Center /ID# 284374
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College Station, Texas, Estados Unidos, 77845
- Reclutamiento
- J and S Studies /ID# 285693
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Dallas, Texas, Estados Unidos, 75225
- Reclutamiento
- Dallas Center for Dermatology and Aesthetics /ID# 284356
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Pflugerville, Texas, Estados Unidos, 78660
- Reclutamiento
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
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Virginia
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Arlington, Virginia, Estados Unidos, 22209
- Reclutamiento
- SkinDC /ID# 284403
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 activo: OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
|
Comparador de placebos: Placebo
Participants will receive a single treatment of placebo. |
Injection |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Up to Day 150
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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)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
- Director de estudio: ABBVIE INC., AbbVie
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M26-312
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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