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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-Mail: abbvieclinicaltrials@abbvie.com
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35205
- Rekrutierung
- Total Skin and Beauty Dermatology Center /ID# 284360
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Arizona
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Glendale, Arizona, Vereinigte Staaten, 85308
- Rekrutierung
- Advanced Research Associates - Glendale /ID# 284389
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California
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Newport Beach, California, Vereinigte Staaten, 92663
- Rekrutierung
- Eye Research Foundation /ID# 284401
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Vista, California, Vereinigte Staaten, 92083
- Rekrutierung
- Pacific Clinical Innovations /ID# 284406
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Connecticut
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Westport, Connecticut, Vereinigte Staaten, 06880
- Rekrutierung
- DMR Research - Westport /ID# 286612
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District of Columbia
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Washington D.C., District of Columbia, Vereinigte Staaten, 20005
- Rekrutierung
- Sherber+Rad /ID# 286392
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30331
- Rekrutierung
- Atlanta Biomedical Clinical Research /ID# 284411
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46260
- Rekrutierung
- Laser and Skin Surgery Center of Indiana /ID# 284383
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Louisiana
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Metairie, Louisiana, Vereinigte Staaten, 70006
- Rekrutierung
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
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New Orleans, Louisiana, Vereinigte Staaten, 70115
- Rekrutierung
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
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New Orleans, Louisiana, Vereinigte Staaten, 70130
- Rekrutierung
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
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Maryland
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Hunt Valley, Maryland, Vereinigte Staaten, 21030
- Rekrutierung
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
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Massachusetts
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Chestnut Hill, Massachusetts, Vereinigte Staaten, 02467
- Rekrutierung
- Skincare Physicians /ID# 284415
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Michigan
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Clarkston, Michigan, Vereinigte Staaten, 48346
- Rekrutierung
- Clarkston Dermatology /ID# 284483
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North Carolina
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Wilmington, North Carolina, Vereinigte Staaten, 28403
- Rekrutierung
- Wilmington Dermatology Center /ID# 284385
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Rekrutierung
- Private Practice - Dr. Brian S. Biesman /ID# 284417
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Texas
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Austin, Texas, Vereinigte Staaten, 78746
- Rekrutierung
- Westlake Dermatology Clinical Research Center /ID# 284374
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College Station, Texas, Vereinigte Staaten, 77845
- Rekrutierung
- J and S Studies /ID# 285693
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Dallas, Texas, Vereinigte Staaten, 75225
- Rekrutierung
- Dallas Center for Dermatology and Aesthetics /ID# 284356
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Pflugerville, Texas, Vereinigte Staaten, 78660
- Rekrutierung
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
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Virginia
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Arlington, Virginia, Vereinigte Staaten, 22209
- Rekrutierung
- SkinDC /ID# 284403
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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 |
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Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
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Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
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Aktiver Komparator: OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
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Placebo-Komparator: Placebo
Participants will receive a single treatment of placebo. |
Injection |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
Zeitfenster: 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)
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Zeitfenster: Day 7
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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
Zeitfenster: 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
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: ABBVIE INC., AbbVie
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M26-312
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-Sharing-Zugriffskriterien
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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