AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 2b Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of AGN-151586 in Participants With Moderate to Severe Glabellar Lines

ClinicalTrials.gov ID

NCT04096326

Acronym / sponsor ID

2034-201-008

Conditions

Glabellar Lines

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

198 participants (actual)

Lead sponsor

AllerganIndustry (pharma, biotech, devices)

Study start

26 Sep 2019 (actual)

Primary completion

9 Sep 2020 (actual)

Study completion

9 Sep 2020 (actual)

First posted

19 Sep 2019 (actual)

Results

Posted 28 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, care provider, investigator)

Number of arms

10

Who may qualify

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7

   Time frame: Baseline (Day 1) through Day 7

   Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

2. Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention.

3. Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.

4. Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP.

5. Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: > 500 msec or change from baseline value: increase of > 60 msec; QTcF observed value: > 500 msec or change from baseline value: increase of > 60 msec.

6. Number of Participants With Anti-drug Antibodies (ADAs)

   Time frame: Up to Day 42

   Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Glabellar Lines

• RecruitingPhase 2

  A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines

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• Active, not recruitingPhase 1

  A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines

  Glabellar Lines

• RecruitingPhase 3

  To Evaluate HU-045 With Moderate to Severe Glabellar Lines

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• Active, not recruitingPhase 3

  A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

  Moderate to Severe Glabellar Lines

• RecruitingPhase 3

  Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

  Moderate to Severe Glabellar Lines

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

9 sites in 1 country: see every site and its status.