A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines

NCT04821089 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: D-FR-10200-0022024-512782-14-00
• Study Type: interventional
• Target: 727
• Locations: 2 countries
• Sites: 10

Brief Summary

The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines. This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants. Stage 1 (phase Ib \& II)

• Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
• Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport
• Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of IPN10200. In the OL phase, participants may receive repeat administrations of IPN10200 for up to three additional cycles (up to four treatment cycles in total during the study). Stage 2 (phase II) - An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL) Stage 3 (phase II) \- A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)

Conditions

Moderate to Severe Upper Facial Lines

Outcome Measures

Primary Outcomes (9)

• Incidence of treatment emergent adverse events (TEAEs) at each dose

  At Stage 1/Step 1, Stage 3

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

• Incidence of serious adverse events (SAEs) at each dose

  At Stage 1/Step 1, Stage 3

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

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

  At Stage 1/Step 1, Stage 3

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

• Response to treatment as measured by the composite response of 2-grade improvement on Investigator's Live Assessment (ILA) at maximum contraction

  At stage 1/Step 2, Step 3; 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"

  At Week 4

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

  At Stage 1/Step 2 and Step 3; 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".

  At Week 4

• Response to treatment as measured by the composite response of 2-grade improvement on ILA at maximum contraction on the forehead lines (FHL) area

  At Stage 2 for the glabellar lines (GL)+ FHL group

  At Week 4

• Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the forehead lines (FHL) area

  At Stage 2 for the glabellar lines (GL)+ FHL group

  At Week 4

• Response to treatment as measured by the composite response of 2-grade improvement ILA at maximum contraction on the lateral canthal lines (LCL) area

  At stage 2 for the LCL group

  At Week 4

• Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the LCL area

  At stage 2 for the LCL group

  At Week 4

Secondary Outcomes (16)

• Response to treatment measured by the composite response of 2-grade improvement on ILA

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

• Response to treatment measured by the composite response of 2-grade improvement on SSA

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

• 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)

Study Arms (3)

IPN10200 group

EXPERIMENTAL

Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation. Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 The decision to escalate to the next dose for each cohort will be based on DMC recommendation . Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1. Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.

Biological: IPN10200

Placebo group

PLACEBO COMPARATOR

Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation. Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 The decision to escalate to the next dose for each cohort will be based on DMC recommendation. Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1. Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.

Biological: IPN10200 Placebo

Dysport group (stage 1 / step 2 and 3 only)

ACTIVE COMPARATOR

Biological: Dysport

Interventions

IPN10200 BIOLOGICAL

Stage 1: Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.

IPN10200 group

IPN10200 Placebo BIOLOGICAL

Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.

Placebo group

Dysport BIOLOGICAL

Single administration of study intervention in stage 1 / step 2 and 3 only

Dysport group (stage 1 / step 2 and 3 only)

Eligibility Criteria

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

You may qualify if:

• Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
• Moderate or severe (Grade 2 or 3) GL (Stage 1) 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 (Stage 1) at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
• Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
• Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
• Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction as assessed by the SSA using a 4-point photographic scale.
• Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction, as assessed by the SSA using a 4-point photographic scale.
• Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines (Stages 1 to 3) at Baseline, as assessed by the SLS.
• Male and female participants (only female for Stage 1/Step 1). Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Capable of giving signed informed consent includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Participant has both the time and the ability to complete the study and comply with study instructions.
• Does not reside in an institution by administrative or court order.
• Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological or legally adopted.

You may not qualify if:

• 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).
• A history of eyelid blepharoplasty or brow lift within the past 5 years
• A history of facial nerve palsy.
• Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
• Any known medical condition that may put the participant at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)
• Has COVID-19 illness or a known positive SARS-CoV-2 test (Stage 1), or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function)
• Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recent treatment (within the past 9 months prior to baseline) with any BoNT serotype for Stage 1 / Step 2, Stage 1/Step 3, Stages 2 and 3. Participants treated in earlier Stages/Steps of the study must not be included in any later Stages/Steps.
• Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
• Any planned facial cosmetic surgery during the study.
• Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention. Therapy considered necessary for the participant's welfare may be given at the discretion of the investigator.
• Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases, aminoglycoside antibiotics and systemic retinoids, within the past 30 days prior to Baseline.
• 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 halflife is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
• Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
• Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study
• An inability to substantially lessen GL and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

MEDITI - Clinique Del Mar

Antibes, France

Location

Aimed S.A.S

Lyon, France

Location

Clinique de Chirurgie Esthétique Iéna

Paris, France

Location

Interdisciplinary Study Association

Kassel, State of Berlin, Germany

Location

CRS Clinical Research Services Berlin GMBH

Berlin, 13353, Germany

Location

Interdisciplinary Study Association

Berlin, Germany

Location

ROSENPARK RESEARCH GmbH

Darmstadt, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, Germany

Location

Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft

Hamburg, Germany

Location

Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow

Mahlow, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: April 6, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 19, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

DE (7); FR (3)