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AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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

Other trials in United States

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

Other trials in Germany

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

Other trials in Japan

France3 sites

  • Sas Aimed

    Lyon, 69006

  • Institut Cyrnos

    Nice, 6000

  • Thinkin SAS

    Paris, 75016

Other trials in France

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.

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 groups in NCT07435428
Study groupRoleWhat they receive
Corabotase groupExperimentalParticipants 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 groupPlacebo comparatorParticipants 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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)

  15. 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)

  16. 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).

  17. For OL phase: Time between two consecutive injections

    Measured: OL phase: 24 weeks after the previous injections until week 80

  18. 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).

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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

  24. 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)

  25. 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

  26. 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.

  1. First posted27 Feb 2026
  2. Study start18 Feb 2026
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Corabotase in people with Moderate to Severe Glabellar Lines, run by Ipsen at 60 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Germany, Japan, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For North America: Percentage of participants responding to treatment (time frame: At week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07435428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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