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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: ABBVIE CALL CENTER
- Telefoonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studie Locaties
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten, 35205
- Werving
- Total Skin and Beauty Dermatology Center /ID# 284360
-
-
Arizona
-
Glendale, Arizona, Verenigde Staten, 85308
- Werving
- Advanced Research Associates - Glendale /ID# 284389
-
-
California
-
Newport Beach, California, Verenigde Staten, 92663
- Werving
- Eye Research Foundation /ID# 284401
-
Vista, California, Verenigde Staten, 92083
- Werving
- Pacific Clinical Innovations /ID# 284406
-
-
Connecticut
-
Westport, Connecticut, Verenigde Staten, 06880
- Werving
- DMR Research - Westport /ID# 286612
-
-
District of Columbia
-
Washington D.C., District of Columbia, Verenigde Staten, 20005
- Werving
- Sherber+Rad /ID# 286392
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30331
- Werving
- Atlanta Biomedical Clinical Research /ID# 284411
-
-
Indiana
-
Indianapolis, Indiana, Verenigde Staten, 46260
- Werving
- Laser and Skin Surgery Center of Indiana /ID# 284383
-
-
Louisiana
-
Metairie, Louisiana, Verenigde Staten, 70006
- Werving
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
-
New Orleans, Louisiana, Verenigde Staten, 70115
- Werving
- DelRicht Research - Prytania Street - New Orleans /ID# 284416
-
New Orleans, Louisiana, Verenigde Staten, 70130
- Werving
- Etre, Cosmetic Dermatology And Laser Center /ID# 284390
-
-
Maryland
-
Hunt Valley, Maryland, Verenigde Staten, 21030
- Werving
- Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
-
-
Massachusetts
-
Chestnut Hill, Massachusetts, Verenigde Staten, 02467
- Werving
- Skincare Physicians /ID# 284415
-
-
Michigan
-
Clarkston, Michigan, Verenigde Staten, 48346
- Werving
- Clarkston Dermatology /ID# 284483
-
-
North Carolina
-
Wilmington, North Carolina, Verenigde Staten, 28403
- Werving
- Wilmington Dermatology Center /ID# 284385
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Private Practice - Dr. Brian S. Biesman /ID# 284417
-
-
Texas
-
Austin, Texas, Verenigde Staten, 78746
- Werving
- Westlake Dermatology Clinical Research Center /ID# 284374
-
College Station, Texas, Verenigde Staten, 77845
- Werving
- J and S Studies /ID# 285693
-
Dallas, Texas, Verenigde Staten, 75225
- Werving
- Dallas Center for Dermatology and Aesthetics /ID# 284356
-
Pflugerville, Texas, Verenigde Staten, 78660
- Werving
- Austin Institute for Clinical Research - Pflugerville /ID# 284375
-
-
Virginia
-
Arlington, Virginia, Verenigde Staten, 22209
- Werving
- SkinDC /ID# 284403
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Experimenteel: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
Injection |
|
Actieve vergelijker: OnabotulinumtoxinA
Participants will receive a single treatment of onabotulinumtoxinA. |
Injection |
|
Placebo-vergelijker: Placebo
Participants will receive a single treatment of placebo. |
Injection |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Tijdsspanne: 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
|
|
Percentage of Participants Achieving None or Mild on the Investigator-Assessed Allergan Glabellar Lines Severity Scale (AGLSS)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: ABBVIE INC., AbbVie
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M26-312
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-toegangscriteria voor delen
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .