A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows (LAURITE 1)

A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group 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

The purpose of this study is to assess the effectiveness and safety of IPN10200 compared to placebo in the improvement of the appearance of moderate to severe glabellar lines in adult participants. 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.

In this study, all participants will receive a single injection of either IPN10200 or placebo (the study drug). 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 (Day 1) where all the eligible participants will receive a single injection of IPN10200 or placebo.
• A follow-up period (52 weeks) where participants' health will be monitored, consisting of regular visits to the study centre and 1 telephone call visit.

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 55 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): 300
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H4E1
      • Not yet recruiting
      • Pacific Dermaesthetics Inc.
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Recruiting
      • Carruthers and Humphrey Cosmetic Medicine
  • Ontario
    • Oakville, Ontario, Canada, L6J 7W5
      • Recruiting
      • Institute of Cosmetic and Laser Surgery
    • Toronto, Ontario, Canada, M5R 3N8
      • Recruiting
      • Sweat clinics of canada
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Not yet recruiting
      • Bertucci MedSpa
  • Quebec
    • Québec, Quebec, Canada, G1V4X7
      • Not yet recruiting
      • Centre de Recherche Dermatologique de Quebec
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Recruiting
      • Skin Wellness Dermatology - Homewood
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Recruiting
      • Advanced Research Associates
    • Scottsdale, Arizona, United States, 85260
      • Not yet recruiting
      • Avacare
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Investigate MD, LLC
  • California
    • Manhattan Beach, California, United States, 90266
      • Recruiting
      • Ablon Skin Institute and Research Center
    • Redondo Beach, California, United States, 90277
      • Recruiting
      • Keith A. Marcus, MD Inc
    • San Diego, California, United States, 92121
      • Not yet recruiting
      • West Dermatology
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Ava T. Shamban, M.D., Inc.
    • Solana Beach, California, United States, 92075
      • Recruiting
      • Art of Skin MD
    • Vista, California, United States, 92083
      • Recruiting
      • Pacific Clinical Innovations Inc.
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Skin Research Institute
  • Maryland
    • Bethesda, Maryland, United States, 20852
      • Recruiting
      • ICON Dermatology and Aesthetics
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Not yet recruiting
      • Clinical Research Center of the Carolinas
  • Texas
    • Austin, Texas, United States, 78746-5059
      • Recruiting
      • Westlake Dermatology & Cosmetic Surgery - Westlake
    • Houston, Texas, United States, 77004
      • Recruiting
      • Dermatology and Laser Surgery Center
    • Pflugerville, Texas, United States, 78660
      • Recruiting
      • Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Recruiting
      • SkinDC

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 inclusive at the time of signing the ICF.
• 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.
• Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, as assessed by the SLS.
• 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 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.

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.
• Presence of any scars, piercings or tattoos (including micro blading 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.
• 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.).
• Administration of any BoNT (other than the study intervention on baseline visit) 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.
• Participants who have received IPN10200 in a previous 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 are 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 non-permanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) 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 photo rejuvenation, 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 UFL 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 prior to baseline visit 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 visit) and during the conduct of the study.
• Known positive for hepatitis B antigen, 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 through injections into the selected muscles on Day 1.	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 through injections into the selected muscles on Day 1.	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 multicomponent response of ≥2-grade improvement from baseline 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.	From baseline to week 4
For EU and ROW: Percentage of participants responding to treatment	Measured by a ≥2-grade improvement on Investigator's Live Assessment (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 North America: Percentage of participants responding to treatment	Measured by the multicomponent response of ≥2-grade improvement from baseline 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 24
For EU and ROW: Response to treatment as measured by a score of 'None' or 'Mild' at Week 4 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."	At week 24
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."	At week 24
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 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 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
For all regions except United States: Number of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on SLS	SLS: a 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 24
For EU: Response as measured by an improvement of ≥ 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 "strongly disagree" to "strongly agree."	At week 4
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."	From baseline to each post-treatment visit until Week 52 (except week 4 [for EU and ROW] and week 24)
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.	From baseline to each post-treatment visit until week 52 (except week 24)
Percentage of participants responding to treatment	Measured by the multicomponent response of 2-grade improvement and a score of 'None or 'Mild' on both the 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 (up to 1 year), (except week 4 and 24 for North America)
Percentage of participants responding to treatment as measured by the response of 2-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."	From baseline to each post-treatment visit until Week 52 (up to 1 year) (except Week 4 for EU and ROW)
Percentage of participants responding to treatment as measured by the response of 2-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 (up to 1 year)
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."	From baseline to each post-treatment visit until Week 52 (up to 1 year)
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] (up to 1 year)
Percentage of participants responding to treatment as measured by the response of 1-grade improvement on ILA at rest	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."	From baseline to each post-treatment visit until Week 52 (up to 1 year)
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 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."	From baseline to each post-treatment visit until Week 52 (up to 1 year), (except Week 4 and 24 for all regions except United States)
Percentage of participants answering 'Improved', 'Much Improved' or 'Very Much Improved', as measured by Global Aesthetic Improvement Scale (GAIS) at maximum frown	GAIS: a validated 7-point categorical scale used to assess global aesthetic improvement in appearance compared to pretreatment, as determined by the participant at maximum frown, where grade -3 = "Very much worse," grade -2 = "Much worse," grade -1 = "Worse," grade 0 = "No change," grade 1 = "Improved," grade 2 = "Much improved," and grade 3 = "Very much improved."	At week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (up to 1 year)
Percentage of participants answering 'Improved', 'Much Improved' or 'Very Much Improved', as measured by GAIS at rest	GAIS: a validated 7-point categorical scale used to assess global aesthetic improvement in appearance compared to pretreatment, as determined by the participant at rest, where grade -3 = "Very much worse," grade -2 = "Much worse," grade -1 = "Worse," grade 0 = "No change," grade 1 = "Improved," grade 2 = "Much improved," and grade 3 = "Very much improved."	At week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (up to 1 year)
Percentage of clinicians answering 'Improved', 'Much Improved' or 'Very Much Improved', as measured by Global Aesthetic Improvement Scale (GAIS) at maximum frown	GAIS: a validated 7-point categorical scale used to assess global aesthetic improvement in appearance compared to pretreatment, as determined by the clinician at maximum frown, where grade -3 = "Very much worse," grade -2 = "Much worse," grade -1 = "Worse," grade 0 = "No change," grade 1 = "Improved," grade 2 = "Much improved," and grade 3 = "Very much improved."	At week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (up to 1 year)
Percentage of clinicians answering 'Improved', 'Much Improved' or 'Very Much Improved', as measured by Global Aesthetic Improvement Scale (GAIS) at rest	GAIS: a validated 7-point categorical scale used to assess global aesthetic improvement in appearance compared to pretreatment, as determined by the clinician with the participant at rest, where grade -3 = "Very much worse," grade -2 = "Much worse," grade -1 = "Worse," grade 0 = "No change," grade 1 = "Improved," grade 2 = "Much improved," and grade 3 = "Very much improved."	At week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (up to one year)
Percentage of participants with change from baseline in psychological function, as measured by Psychological Well-Being Scale on FACE-Q	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 "strongly disagree" to "strongly agree."	At baseline, week 1, 2, 4 (except the EU), 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (up to 1 year)
Time to onset of treatment response based on subject 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.	At baseline and daily from Day 1 to Day 8 (Week 1)
Time taken for a responder to re-exhibit their baseline severity grade 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 maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	At all timepoints post-injection (Day 1) until end of study (up to 1 year)
Time taken for a responder to re-exhibit a severity grade of 'Moderate' or 'Severe' as measured by 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 maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	At all timepoints post-injection (Day 1) until end of study (up to 1 year)
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.	At all timepoints post-injection (Day 1) until end of study (up to 1 year)
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.	At all timepoints post-injection (Day 1) until end of study (up to 1 year)
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 (Day 1) until end of study (up to 1 year)
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 (Day 1) until end of study (up to 1 year)
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings		At week 4 and week 52
Percentage of participants with clinically significant change from baseline in facial examination	Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.	At all timepoints post-injection (Day 1) until end of study (up to 1 year)
Percentage of participants with binding antibodies to IPN10200		At screening, week 4, 12, 24, 36 and 52 (up to 1 year 1 month)
Percentage of participants with neutralising antibodies to IPN10200		At screening, week 4, 12, 24, 36 and 52 (up to 1 year 1 month)

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 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-10200-459

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