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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35205
- Rekruttering
- Total Skin and Beauty Dermatology Center /ID# 284360
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Arizona
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Glendale, Arizona, Forente stater, 85308
- Rekruttering
- Advanced Research Associates - Glendale /ID# 284389
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California
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Newport Beach, California, Forente stater, 92663
- Rekruttering
- Eye Research Foundation /ID# 284401
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Vista, California, Forente stater, 92083
- Rekruttering
- Pacific Clinical Innovations /ID# 284406
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Connecticut
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Westport, Connecticut, Forente stater, 06880
- Rekruttering
- DMR Research - Westport /ID# 286612
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20005
- Rekruttering
- Sherber+Rad /ID# 286392
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Georgia
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Atlanta, Georgia, Forente stater, 30331
- Rekruttering
- Atlanta Biomedical Clinical Research /ID# 284411
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Indiana
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Indianapolis, Indiana, Forente stater, 46260
- Rekruttering
- Laser and Skin Surgery Center of Indiana /ID# 284383
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
- Rekruttering
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
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New Orleans, Louisiana, Forente stater, 70115
- Rekruttering
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
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New Orleans, Louisiana, Forente stater, 70130
- Rekruttering
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
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Maryland
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Hunt Valley, Maryland, Forente stater, 21030
- Rekruttering
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
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Massachusetts
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Chestnut Hill, Massachusetts, Forente stater, 02467
- Rekruttering
- Skincare Physicians /ID# 284415
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Michigan
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Clarkston, Michigan, Forente stater, 48346
- Rekruttering
- Clarkston Dermatology /ID# 284483
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North Carolina
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Wilmington, North Carolina, Forente stater, 28403
- Rekruttering
- Wilmington Dermatology Center /ID# 284385
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Private Practice - Dr. Brian S. Biesman /ID# 284417
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Texas
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Austin, Texas, Forente stater, 78746
- Rekruttering
- Westlake Dermatology Clinical Research Center /ID# 284374
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College Station, Texas, Forente stater, 77845
- Rekruttering
- J and S Studies /ID# 285693
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Dallas, Texas, Forente stater, 75225
- Rekruttering
- Dallas Center for Dermatology and Aesthetics /ID# 284356
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Pflugerville, Texas, Forente stater, 78660
- Rekruttering
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
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Virginia
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Arlington, Virginia, Forente stater, 22209
- Rekruttering
- SkinDC /ID# 284403
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Eksperimentell: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Aktiv komparator: OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
|
Placebo komparator: Placebo
Participants will receive a single treatment of placebo. |
Injection |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Tidsramme: 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
Tidsramme: 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
|
|
Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: ABBVIE INC., AbbVie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M26-312
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Tilgangskriterier for IPD-deling
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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