Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines.

NCT04736745 | Terminated Phase 1 DMC

• 2 other identifiers: D-FR-59011-0012019-003268-33
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles.

Conditions

Moderate Upper Facial Lines; Severe Upper Facial Lines

Outcome Measures

Primary Outcomes (7)

• Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation

  from baseline until the end of study (9 months)

• Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation

  from baseline until the end of study (9 months)

• Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation

  from baseline until the end of study (9 months)

• Incidence of AEs (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) for dose escalation

  from baseline until the end of study (9 months)

• Presence of botulinum neurotoxin serotype A (BoNT-A) antibodies and IPN59011 antibodies and titres (binding and neutralizing)

  from baseline until the end of study (9 months)

• Response to treatment measured by the composite response of 2-grade improvement on investigator's live assessment (ILA) at maximum contraction.

  ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced".

  Day 29

• Response to treatment measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction.

  SSA: a validated 4-point categorical scale to assess the appearance of their Glabellar Lines (GLs) at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles".

  Day 29

Secondary Outcomes (9)

• Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction

  From the baseline to the end of the study (9 months)

• Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction

  From the baseline to the end of the study (9 months)

• Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest

  From the baseline to the end of the study (9 months)

• Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction

  From the baseline to the end of the study (9 months)

• Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction

  From the baseline to the end of the study (9 months)

Study Arms (4)

Dose escalation

EXPERIMENTAL

One single injection of study medication (IPN59011 or Placebo) will be injected locally. IPN59011 is injected in a dose-escalation manner. In total for this stage at least 40 subjects.

Biological: IPN59011; Drug: Placebo

Dose ranging

EXPERIMENTAL

Up to two IPN59011dose(s) groups will be included in parallel groups versus Azzalure group and placebo group. One single injection of study medication will be injected locally into several sites. In total for this stage at least 70 subjects.

Biological: IPN59011; Biological: Azzalure; Drug: Placebo

Additional dose ranging

EXPERIMENTAL

Dose-ranging for three additional placebo-controlled parallel groups. One single injection of study medication will be injected locally into several sites, concomitantly and non-concomitantly. In total for this stage at least 110 subjects.

Biological: IPN59011; Drug: Placebo

Total dose for Upper Facial Lines

EXPERIMENTAL

One single injection of study medication will be injected locally into Upper Facial Lines. In total for this stage approximately 48 subjects.

Biological: IPN59011; Drug: Placebo

Interventions

IPN59011 BIOLOGICAL

Powder and solvent for solution for injection

Additional dose ranging; Dose escalation; Dose ranging; Total dose for Upper Facial Lines

Azzalure BIOLOGICAL

Powder for solution for injection

Dose ranging

Placebo DRUG

Powder for solution for injection

Additional dose ranging; Dose escalation; Dose ranging; Total dose for Upper Facial Lines

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent prior to any study related procedures.
• Female and male subjects between 18 and 65 years of age, inclusive (for dose escalation females only)
• Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
• Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
• Moderate or severe (Grade 2 or 3) Forehead Lines (FHL) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) Lateral Canthal Lines (LCL) at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
• Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
• Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the by the SSA using a validated 4-point categorical scale.
• Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the by the SSA using a validated 4-point categorical scale.
• Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the subject's level of satisfaction.
• A negative pregnancy test (for females of childbearing potential only). Non-childbearing potential is defined as postmenopausal for at least 1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy.
• Subject has both the time and the ability to complete the study and comply with study instructions.

You may not qualify if:

• Previous treatment with any Botox (BTX) serotype (for dose escalation at least) or any recent treatment (within the past 6 months prior to Baseline for the rest of the study) with any BTX serotype.
• Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
• Any prior treatment with long lasting dermal fillers in the upper face including the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the 12 months prior to Baseline.
• Any planned facial cosmetic surgery during the study.
• A history of eyelid blepharoplasty or brow lift within the past 5 years.
• An inability to substantially reduce GL by physically spreading them apart or lack of capacity to frown.
• An active infection or other skin problems in the upper face including the GL, FHL and LCL area (e.g. acute acne lesions or ulcers).
• Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
• Pregnant women, nursing women, premenopausal women or women of childbearing potential (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for a minimum of 12 weeks following last administration of study treatment. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, or vasectomised partner.
• Male subjects who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation for a minimum of 12 weeks following initial double-blind administration of the treatment.
• Positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
• A history of drug or alcohol abuse.
• Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
• Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject's participation in the study.
• Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Clinical Research Centre (CRS)

Berlin, D-13353, Germany

Location

MeSH Terms

Interventions

abobotulinumtoxinA

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For dose escalation part Sequential study model will be used. For the rest of the study parallel assignment will be used.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 3, 2021
• Study Start: February 10, 2021
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)