A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows (LAURITE 2)

A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled and Open-label Study to Evaluate the Efficacy and Safety of a Single Dose of IPN10200 in the Improvement of Moderate to Severe Glabellar Lines in Adult Participants, and to Evaluate the Long-term Efficacy and Safety of Repeat Doses of IPN10200 in the Same Indication

The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) and how well and safely repeat doses of IPN10200 work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence.

All participants in the double-blind phase will receive IPN10200 or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with IPN10200 depending on their eligibility.

There will be 3 periods in this study:

• A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
• A treatment period where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of IPN10200 or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of IPN10200. In the open-label phase (de novo participants), participants will receive IPN10200 in the first cycle and eligible participants may receive additional cycles of IPN10200. Requires multiple visits during the first month followed by 1 visit every month.
• A follow-up period (24 weeks) after the last injection where participants' health will be monitored.

Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary.

Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Glabellar Lines
• Intervention / Treatment: Biological: IPN10200; Biological: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ipsen Recruitment Enquiries; Phone Number: See email; Email: clinical.trials@ipsen.com

Study Locations

• France
  • Lyon, France, 69006
    • Not yet recruiting
    • Sas Aimed
  • Nice, France, 6000
    • Not yet recruiting
    • Institut Cyrnos
  • Paris, France, 75016
    • Not yet recruiting
    • Thinkin SAS
• Germany
  • Darmstadt, Germany, 64283
    • Not yet recruiting
    • Rosenpark Research GmbH
  • Düsseldorf, Germany, 40212
    • Not yet recruiting
    • Privatpraxis Dr. Hilton & Partner
  • Hamburg, Germany, 20146
    • Not yet recruiting
    • Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
  • Hamburg, Germany, 22609
    • Not yet recruiting
    • Derma Science GmbH
  • Kassel, Germany, 34117
    • Not yet recruiting
    • Noahklinik- Klinik fuer Plastische Chirurgie
  • Mahlow, Germany, 15831
    • Not yet recruiting
    • Dermatologische Gemeinschaftspraxis
  • München, Germany, 80333
    • Not yet recruiting
    • Skin Concept - Private Dermatology Practice
  • Potsdam, Germany, 14467
    • Not yet recruiting
    • Haut- und Lasercentrum Potsdam
• Japan
  • Chiyoda-ku, Japan, 101-0021
    • Recruiting
    • Akihabara Skin Clinic
  • Chūōku, Japan, 103-0027
    • Recruiting
    • Medical Corporation Chiseikai - Tokyo Center Clinic
  • Fukuoka, Japan, 810-0022
    • Recruiting
    • Josui Dermatology Clinic
  • Minatoku, Japan, 107-0052
    • Recruiting
    • Clinica BellaForma
  • Nerima-ku, Japan, 177-0041
    • Recruiting
    • Forest Palace Dermatology Clinic
  • Sakaishi, Japan, 593-8324
    • Recruiting
    • Kume Derma Clinic
  • Sapporo, Japan, 063-0812
    • Recruiting
    • Kotoni Tower Dermatology and Plastic Surgery
  • Takatsuki-shi, Japan, 569-0824
    • Recruiting
    • Yoshikawa Skin Clinic
• United States
  • California
    • Los Angeles, California, United States, 90025
      • Not yet recruiting
      • Rivkin Westside Aesthetics
    • Los Angeles, California, United States, 91436
      • Recruiting
      • Clinical Testing of Beverly Hills
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Eye Research Foundation
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Steve Yoelin MD Medical Associates Inc
    • Pasadena, California, United States, 91105
      • Recruiting
      • Skin and Beauty Center
    • San Diego, California, United States, 92121
      • Not yet recruiting
      • Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
    • Santa Ana, California, United States, 92701
      • Not yet recruiting
      • Southern California Dermatology, Inc.
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Recruiting
      • DMR Research, PLLC
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Not yet recruiting
      • Center for Dermatology and Dermatologic Surgery
  • Florida
    • Aventura, Florida, United States, 33180
      • Recruiting
      • Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
    • Bradenton, Florida, United States, 34209
      • Recruiting
      • Weinkle Dermatology
    • Coral Gables, Florida, United States, 33146
      • Not yet recruiting
      • Skin Research Institute
    • Miami, Florida, United States, 33133
      • Recruiting
      • Miami Dermatology & Laser Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Kavali Plastic Surgery and Skin Renewal Center
  • Illinois
    • Chicago, Illinois, United States, 60654-5826
      • Recruiting
      • Chicago Cosmetic and Dermatologic Research
    • Chicago, Illinois, United States, 60610
      • Recruiting
      • DeNova Research
    • Lincolnshire, Illinois, United States, 60069
      • Not yet recruiting
      • Advanced Dermatology, A Forefront Dermatology Practice
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • LASSI - Laser and Skin Surgery Center of Indiana
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Not yet recruiting
      • Coleman Center For Cosmetic Dermatologic Surgery
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70130
      • Recruiting
      • Etre, Cosmetic Dermatology and Laser Center
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Recruiting
      • Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • Lawrence J. Green, MD. LLC
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Recruiting
      • Skincare Physicians
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Michigan Center for Research Company
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • Skin Specialists PC dba Schlessinger MD
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Recruiting
      • StracSkin
  • New York
    • Latham, New York, United States, 12110
      • Recruiting
      • Rejuva Center at Williams
    • Mount Kisco, New York, United States, 10549
      • Recruiting
      • The Center for Dermatology, Cosmetic & Laser Surgery
    • New York, New York, United States, 10021
      • Recruiting
      • Luxurgery
    • New York, New York, United States, 10028
      • Recruiting
      • Dr. Z. Paul Lorenc MD, Office Of
    • Rochester, New York, United States, 14623
      • Recruiting
      • Skin Search of Rochester, Inc.
    • Victor, New York, United States, 14561
      • Not yet recruiting
      • Rochester Dermatologic Surgery, P.C.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Recruiting
      • Aesthetic Solutions P.A.
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
  • Ohio
    • Powell, Ohio, United States, 43065
      • Recruiting
      • Nash Research Group, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Recruiting
      • Paddington Testing Company
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Recruiting
      • Tennessee Clinical Research Center
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Brian S. Biesman MD, PLLC
  • Texas
    • Webster, Texas, United States, 77598
      • Not yet recruiting
      • Center for Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
• Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
• Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
• Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed by the SLS score.
• For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Participant has both the time and 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.

Exclusion Criteria:

• An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
• A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
• A history of facial nerve palsy.
• Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
• Closed-angle glaucoma or a predisposition to it (for Japan only).
• Any known medical condition that may put the participant at increased risk with regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.).
• Presence of any scars, piercings, or tattoos (including microblading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could interfere with evaluations.
• Administration of any BoNT (other than the study intervention) into any site of the body and for any indication from 9 months prior to the first study visit until the end of the study.
• Treatment with IPN10200 in any prior study.
• Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline is prohibited or a longer washout period of at least five half lives might be required, as deemed appropriate by the investigator for long-acting medications.
• Use of aminoglycoside antibiotics within the past 30 days prior to baseline are prohibited. Note: Topical use apart from the area of injection would be acceptable.
• Use of systemic retinoids within the past 30 days prior to baseline and planned use during the study. Note: Topical retinoids are allowed other than in the areas that will be injected (upper facial area) at the discretion of the investigator.
• Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
• Administration of any nonpermanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid or polymethyl-methacrylate) for soft tissue augmentation therapy in the GL region within 12 months prior to baseline.
• Any prior facial treatment or aesthetic procedures to the upper face including photorejuvenation, vascular or pigment laser or microneedling within the 3 months prior to baseline.
• Any prior facial treatment or aesthetic procedures to the upper face involving skin resurfacing (including dermabrasion, laser, or whatever the interventional technique used) or chemical peel within the past 12 months prior to baseline.
• Any planned cosmetic surgery or aesthetic procedures to the upper face during the study and/or any procedures to other parts of the face which in the investigator's opinion, could interfere with evaluations during the study.
• Any past surgery in the upper facial line area including GL.
• Planned 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. Note: If the permissibility of a specific medication/treatment is in question, the medical monitor will be contacted.
• 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.
• Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus 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 as determined by the investigator.
• Known allergy or hypersensitivity to BoNT or any excipients of IPN10200.
• A history of chronic or recreational drug abuse as assessed by the investigator.
• Any uncontrolled systemic disease or other significant medical condition which would be harmful for the participant to be entered into the study or continue participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IPN10200 group; Participants will receive IPN10200 via injection into the selected muscles on Day 1 of the double-blind (DB) phase. Participants who are new to treatment (the de novo phase) will receive IPN10200 via injections into the selected muscles during the first and subsequent treatment cycles.	Biological: IPN10200; A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
Placebo Comparator: Placebo group; Participants will receive placebo via injection into the selected muscles on Day 1 of the DB phase.	Biological: Placebo; A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For North America: Percentage of participants responding to treatment	Measured by the multi-component response of ≥2-grade improvement and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	At week 4
For EU and ROW: Percentage of participants responding to treatment as measured by ≥2-grades improvement on the ILA at maximum frown	ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	From baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For Double Blind (DB) phase: For North America: Percentage of participants responding to treatment	Measured by the composite response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA and SSAat maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	At week 24
For DB phase: Percentage participants responding to treatment as measured by a score of "None" or "Mild on ILA at maximum frown	ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	At each post-treatment visit except week 4 (For EU and ROW) and week 24 (for United States) up to week 24
For DB phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild on SSA at maximum frown	SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	At week 24
For DB phase: For all regions except United States: Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on Subject's Level of Satisfaction (SLS)	SLS: a validated 4-point categorical scale used to assess satisfaction with the appearance of glabellar lines, where grade 0 = "Very satisfied," grade 1 = "Satisfied," grade 2 = "Dissatisfied," and grade 3 = "Very dissatisfied."	At week 4 and week 24
For DB and Open Label (OL) phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild" on ILA at maximum frown	ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	DB phase: From baseline to each post-treatment visit until week 52 (except week 4 (for EU and all other regions) and week 24); OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild" on SSA at maximum frown	SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	DB phase: From baseline to each post-treatment visit until week 52 (except week 24); OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment	Measured by the multi-component response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA and SSA at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	From baseline to each post-treatment visit until week 52 (except week 4 and week 24 [for North America]); OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA at maximum frown	ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	From baseline to each post-treatment visit until week 52 (except week 4 and week 24 [for North America]); OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥2-grade improvement and a score of 'None' or 'Mild' on SSA at maximum frown	SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	DB phase: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥1-grade improvement on ILA at maximum frown	ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	DB phase: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥1-grade improvement on SSA at maximum frown	SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."	From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥1-grade improvement on ILA at rest	LA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at rest, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	DB phase: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on SLS	SLS: a validated 4-point categorical scale used to assess satisfaction with the appearance of glabellar lines, where grade 0 = "Very satisfied," grade 1 = "Satisfied," grade 2 = "Dissatisfied," and grade 3 = "Very dissatisfied."	DB phase: From baseline to each post-treatment visit until week 52 (except week 4 and week 24 [for United States]); OL phase: From baseline to each post-treatment visit until week 104
For DB and OL phase: Percentage of participants with change from baseline in ageing appearance, as measured by visual analogue scale (VAS) on FACE-Q	FACE-Q Ageing Appearance VAS: a validated visual analogue scale used to assess participants' perceived age compared with their actual age. Participants respond to the question, "How many years younger or older do you think you look compared with your actual age?" by selecting a point on the scale, where negative values indicate years younger and positive values indicate years older	DB phase: For each post-treatment visit until end of DB phase (week 52); OL phase: From baseline to all visits until end of OL phase (week 104)
For DB and OL phase: Percentage of participants with an improvement of at least 10 points from baseline on the Rasch Transformed Score of the FACE-Q Psychological Function Scale	FACE-Q Psychological Function Scale: a validated 4-point categorical scale used to assess participants' psychological well-being. The scale consists of statements about how participants feel about themselves, with responses indicating the level of agreement on a 4-point scale ranging from "definitely disagree" to "definitely agree."	DB phase: From baseline to all visits until end of DB phase (week 52) (except at week 4 for EU); OL phase: From baseline to all visits until end of OL phase (week 104)
For DB phase: Time to onset of treatment response based on participant diary to evaluate the appearance of their lines	Participants record in a diary whether they notice an improvement in the appearance of their glabellar lines, with responses captured as Yes/No.	From baseline and daily from Day 1 to Day 8 (week 1).
For OL phase: Time between two consecutive injections		OL phase: 24 weeks after the previous injections until week 80
For DB phase: Time taken for a responder to re-exhibit a severity grade of 'Moderate' or 'Severe' on the ILA at maximum frown	Responder is defined as having a score of 'None' or 'Mild' on the ILA. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at rest, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	At all timepoints post-injection until end of DB phase (week 52).
For DB and OL phase: Percentage of participants experiencing treatment emergent adverse events (TEAEs).	An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.	DB phase: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until end of OL phase (week 104)
For DB and OL phase: Percentage of participants experiencing serious adverse events (SAEs).	A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or is considered medically significant by the investigator.	DB phase: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)
For DB and OL phase: Percentage of participants experiencing Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs).	An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began. Adverse events of special interest (AESIs) are AEs that may not be serious but are of special importance to a particular drug or class of drugs.	At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)
For DB and OL phase: Percentage of participants with clinically significant changes from baseline in vital signs.	Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.	At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)
For DB and OL phase: Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings		DB phase: At baseline, week 4 and 52; OL phase: Up to week 104
For DB and OL phase: Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination	Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.	DB phase: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)
For DB and OL phase: Percentage of participants with binding antibodies to IPN10200		DB phase: At screening, week 4, 12, 24, 36, 52, & EoS; OL phase: At baseline, week 4, 12, 24, 36, 52 of each cycle & EoS. Cycle 1 is up to 1 year for DB & 18 months for OL, Cycle 2 up to 1 year 1 month, Cycle 3 up to 8 months, and Cycle 4 up to 6 months
For DB and OL phase: Percentage of participants with neutralising antibodies to IPN10200		DB phase: At screening, week 4, 12, 24, 36, 52, & EoS; OL phase: At baseline, week 4, 12, 24, 36, 52 of each cycle & EoS. Cycle 1 is up to 1 year for DB & 18 months for OL, Cycle 2 up to 1 year 1 month, Cycle 3 up to 8 months, and Cycle 4 up to 6 months

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CLIN-10200-458; 2025-522618-22-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
• IPD Sharing 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.
• IPD Sharing 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/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No