Moderate to Severe Glabellar LinesPhase 3LAURITE 2NCT07435428
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
A Phase 3 study testing Corabotase in people with Moderate to Severe Glabellar Lines, run by Ipsen at 60 sites in 4 countries.
Trial summary
The purpose of this study is to assess the effectiveness and safety of a single dose of Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- Corabotase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,300 participants
- Where
- 60 sitesin 4 countries
- Study dates
- 18 Feb 2026to 1 Oct 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
60 sites in 4 countries.
60 sites in 4 countries
United States41 sites
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, 30328
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
Aventura, Florida, 33180
Weinkle Dermatology
Bradenton, Florida, 34209
Aesthetic Solutions P.A.
Chapel Hill, North Carolina, 27517
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
Charlotte, North Carolina, 28207
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
DeNova Research
Chicago, Illinois, 60610
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois, 60654-5826
Michigan Center for Research Company
Clarkston, Michigan, 48346
Skin Research Institute
Coral Gables, Florida, 33146
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
Hunt Valley, Maryland, 21030
LASSI - Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, 46260
Rejuva Center at Williams
Latham, New York, 12110
Advanced Dermatology, A Forefront Dermatology Practice
Lincolnshire, Illinois, 60069
Rivkin Westside Aesthetics
Los Angeles, California, 90025
Clinical Testing of Beverly Hills
Los Angeles, California, 91436
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, 70006
Miami Dermatology & Laser Research
Miami, Florida, 33133
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, 10549
Brian S. Biesman MD, PLLC
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
DelRicht Research
New Orleans, Louisiana, 70115
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130
Luxurgery
New York, New York, 10021
Dr. Z. Paul Lorenc MD, Office Of
New York, New York, 10028
Eye Research Foundation
Newport Beach, California, 92663
Steve Yoelin MD Medical Associates Inc
Newport Beach, California, 92663
Skin Specialists PC dba Schlessinger MD
Omaha, Nebraska, 68144
Skin and Beauty Center
Pasadena, California, 91105
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
Oregon Dermatology and Research Center
Portland, Oregon, 97210
StracSkin
Portsmouth, New Hampshire, 03801
Nash Research Group, LLC
Powell, Ohio, 43065
Skin Search Of Rochester, Inc.
Rochester, New York, 14623
Lawrence J. Green, MD. LLC
Rockville, Maryland, 20850
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
San Diego, California, 92121
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Rochester Dermatologic Surgery, P.C.
Victor, New York, 14561
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, 20037
Center for Clinical Studies
Webster, Texas, 77598
DMR Research, PLLC
Westport, Connecticut, 06880
Germany8 sites
Rosenpark Research GmbH
Darmstadt, 64283
Privatpraxis Dr. Hilton & Partner
Düsseldorf, 40212
Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
Hamburg, 20146
Derma Science GmbH
Hamburg, 22609
Noahklinik- Klinik fuer Plastische Chirurgie
Kassel, 34117
Dermatologische Gemeinschaftspraxis
Mahlow, 15831
Skin Concept - Private Dermatology Practice
München, 80333
Haut- und Lasercentrum Potsdam
Potsdam, 14467
Japan8 sites
Akihabara Skin Clinic
Chiyoda-ku, 101-0021
Medical Corporation Chiseikai - Tokyo Center Clinic
Chūōku, 103-0027
Josui Dermatology Clinic
Fukuoka, 810-0022
Clinica BellaForma
Minatoku, 107-0052
Forest Palace Dermatology Clinic
Nerima-ku, 177-0041
Kume Derma Clinic
Sakaishi, 593-8324
Kotoni Tower Dermatology and Plastic Surgery
Sapporo, 063-0812
Yoshikawa Skin Clinic
Takatsuki-shi, 569-0824
France3 sites
Sas Aimed
Lyon, 69006
Institut Cyrnos
Nice, 6000
Thinkin SAS
Paris, 75016
About this study
Official title: 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 Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase 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 Corabotase 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 Corabotase depending on their eligibility.
Read more
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 Corabotase or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of Corabotase . In the open-label phase (de novo participants), participants will receive Corabotase in the first cycle and eligible participants may receive additional cycles of Corabotase. 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.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- Corabotase, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorabotaseBiological
Also called IPN10200
A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
PlaceboBiological
A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.
| Study group | Role | What they receive |
|---|---|---|
| Corabotase group | Experimental | Participants will receive Corabotase 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 Corabotase via injections into the selected muscles during the first and subsequent treatment cycles. Receives: Biological: Corabotase |
| Placebo group | Placebo comparator | Participants will receive placebo via injection into the selected muscles on Day 1 of the DB phase. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: From baseline to week 4
Secondary outcomes (26)
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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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
Measured: 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."
Measured: 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.
Measured: From baseline and daily from Day 1 to Day 8 (week 1).
For OL phase: Time between two consecutive injections
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start18 Feb 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar LinesStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435428
- Sponsor's protocol ID
- CLIN-10200-458
- Other IDs
- 2025-522618-22-00, 2025
- Acronym
- LAURITE 2
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.