臨床研究等提出・公開システム

A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatmentof Japanese Subjects with Moderate to Severe Glabellar Lines

Study of AGN-151586 in Japanese Participants with Moderate to Severe Glabellar Lines

24

Adult subjects (18 to 64 years of age) with GL severity of Grade 2 (Moderate) or 3 (Severe) assessed by the investigator using the FWS-A at maximum frown (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe). Subjects must not have uncontrolled systemic disease and not have received any botulinum neurotoxin for any serotype for aesthetic treatment within the last 6 months and for therapeutic treatment within the last 12 months prior to Baseline Day 1 visit.

A total of 24 subjects were planned and enrolled at 1 site. All were included in the analysis.

The incidence of TEAEs in the Total AGN-151586 group was lower than in the Total Placebo group. No TEAE was reported more than once. No TESAEs were reported and no TEAEs led to study drug discontinuation. One eyelid ptosis and 1 Mephisto sign TEAE reported in the same subject who received AGN-151586 Cohort 2 were deemed by the investigator as study drug-related; these events were considered local events in the GL indication. There were no TEAEs reported that were consistent with distant spread of toxin. No clinically meaningful changes from Baseline in laboratory values, ECG parameters, and vital sign parameters were observed. Overall, the safety profile of AGN-151586 was acceptable. All analyzed samples from enrolled subjects were negative for binding antibodies to AGN-151586. Therefore, no further testing for neutralizing antibodies to AGN-151586 was performed.

The primary endpoint, the achievement of a >= 2-grade improvement from Baseline in the investigator assessment of GL severity on the FWS-A at maximum frown at any timepoint through Day 7, demonstrated greater efficacy for each of the AGN-151586 dose groups than the Total Placebo group. No formal statistical testing was performed.

This was a 6-week, single-center, double-blind, Phase 1/2 study conducted in Japan. Each eligible subject could receive 1 study treatment with AGN-151586 or placebo. A single treatment administered as 5 intramuscular injections of AGN-151586 or placebo were administered in the glabellar complex on Baseline Day 1, Hour 0, based on randomization (3:1 ratio of AGN-151586:placebo).

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 and 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. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinicaltrials/clinical-trials-data-and-information-sharing.html

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230499

Yajima Yoko

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Complete

Jan. 05, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Participants must be in good health as per investigator'sjudgment based on medical history, physical examination,neurological assessment, clinical laboratory evaluations,ECG results, and vital sign measurements.
- Participants must have moderate or severe GL at maximum frown as assessed by the investigator using theFWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.

- Participants must not have uncontrolled systemic disease.
- History of known immunization to any botulinum neurotoxin serotype
- Tattoos, jewelry, or clothing which obscure the glabellararea and cannot be removed.
- Anticipated need for surgery or overnight hospitalizationduring the study.
- History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
- History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Female subject who is pregnant or breastfeeding, and isconsidering becoming pregnant or donating eggs during thestudy or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
- Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- Anticipated need for treatment with botulinum neurotoxinof any serotype for any reason during the study (other thanstudy drug).

Both

Glabellar Lines

AGN-151586 or Placebo
Experimental: Dose 1,2,or 3
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1.
Placebo Comparator: Placebo
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1.

Percentage of participants with a >= 2-grade improvement from baseline on the Facial Wrinkle Scale with Asian (FWS-A) Photonumeric Guide according to investigator assessment of Glabellar Lines (GL) severity at maximum frown, at anytimepoint through Day 7

Percentage of participants with a >= 2-grade improvement from baseline on theFWS-A according to investigator assessment of GL severity at maximum frownover time
Percentage of participants with a >= 1-grade improvement from baseline on theFWS-A according to investigator assessment of GL severity at maximum frownover time
Percentage of participants with a None or Mild on the FWS-A according toinvestigator assessment of GL severity at maximum frown over time

Oct. 20, 2023

none