A study to assess the effectiveness and safety of IPN10200 over time in adults with moderate to severe wrinkle-like lines between the eyebrows (LAURITE 2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ipsen Innovation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Physical Phenomena [G01]

Decision date (initial)

2026-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ipsen Innovation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the efficacy of a single dose of IPN10200 compared to placebo in improving the appearance of moderate to severe Glabellar Lines (GL) at Week 4 at Maximum Frown (MF)

Secondary objectives 13

1. 1) DOUBLE BLIND PHASE: To assess the efficacy of a single dose of IPN10200 compared to placebo in the improvement of the appearance of moderate to severe GL at each post-treatment timepoint.
2. 2) DOUBLE BLIND PHASE: To assess the participant satisfaction with the treatment of a single dose of IPN10200 compared to placebo in the improvement of the appearance of moderate to severe GL at each post-treatment timepoint.
3. 3) DOUBLE BLIND PHASE: To evaluate any change in psychological function following the treatment of a single dose of IPN10200 compared to placebo at each post treatment visit.
4. 4) DOUBLE BLIND PHASE: To assess time to onset of treatment response.
5. 5) DOUBLE BLIND PHASE: To assess the duration of response.
6. 6) DOUBLE BLIND PHASE: To evaluate the safety and tolerability of IPN10200 following a single dose.
7. 7)DOUBLE BLIND PHASE: To assess the presence of IPN10200 antibodies following a single treatment.
8. 8) OPEN LABEL PHASE: To assess the efficacy profiles of a repeat dose(s) of IPN10200 in improving the appearance of moderate to severe GL.
9. 9) OPEN LABEL PHASE: To assess participant satisfaction with facial appearance following a repeat dose(s) of IPN10200 in the improvement of moderate to severe GL at each post treatment visit within each cycle.
10. 10) OPEN LABEL PHASE: To evaluate any change in psychological function following the repeat dose(s) of IPN10200 at each post treatment visit within each cycle.
11. 11) OPEN LABEL PHASE: To assess the time to retreatment.
12. 12) OPEN LABEL PHASE: To evaluate the safety and tolerability of IPN10200 following repeat dose(s).
13. 13) OPEN LABEL PHASE: To assess the presence of IPN10200 antibodies following repeat treatments.

Conditions and MedDRA coding

Treatment of moderate to severe glabellar lines

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share 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. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board. Supporting Information 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 EU or after the primary manuscript describing the results has been accepted for publication, whichever is later. Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available at https://vivli.org/members/ourmembers/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1) Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
2. 2) Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
3. 3) Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
4. 4) Are ‘dissatisfied’ or ‘very dissatisfied’ with their GLs at baseline, as assessed by the SLS score.
5. 5) For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. 6) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
7. 7) Participant has both the time and ability to complete the study and comply with study instructions.
8. 8) Does not reside in an institution by administrative or court order.
9. 9) 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 26

1. 1) An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
2. 2) A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
3. 3) A history of facial nerve palsy.
4. 4) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
5. 5) Closed-angle glaucoma or a predisposition to it (for Japan only).
6. 6) 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.).
7. 7) 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.
8. 8) 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.
9. 9) Treatment with IPN10200 in any prior study.
10. 10) 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.
11. 11) 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.
12. 12) 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.
13. 13) Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
14. 14) 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.
15. 15) 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.
16. 16) 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.
17. 17) 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.
18. 18) Any past surgery in the upper facial line area including GL.
19. 19) 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.
20. 20) 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.
21. 21) Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus or a diagnosis of acquired immunodeficiency syndrome.
22. 22) 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.
23. 23) An inability to substantially lessen GL as determined by the investigator.
24. 24) Known allergy or hypersensitivity to BoNT or any excipients of IPN10200.
25. 25) A history of chronic or recreational drug abuse as assessed by the investigator.
26. 26) 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1) For North America: Multi-component response as measured by an improvement of at least 2 grades from baseline and a score of ‘None’ or ‘Mild’ at Week 4 on the Investigator's Live Assessment (ILA) and Subject's self-Assessment (SSA) at Maximum Frown (MF).
2. 2) For EU and ROW: An improvement of at least 2 grades from baseline at Week 4 on the ILA at MF.

Secondary endpoints 31

1. 1) DOUBLE BLIND PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the Investigator Live Assessment (ILA) at Maximum Frown (MF) at each post treatment visit (except at Week 4 (for EU and ROW) and Week 24).
2. 2) DOUBLE BLIND PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the Subject's Self Assessment (SSA) at MF at each post treatment visit (except Week 24).
3. 3) DOUBLE BLIND PHASE: Multi-component response as measured by a 2 grade improvement and a score of ‘None’ or ‘Mild’ on both the ILA and SSA at MF at each post treatment visit (except at Week 4 and Week 24 (for North America)).
4. 4) DOUBLE BLIND PHASE: 2-grade improvement on the ILA at MF at each post-treatment visit (except at Week 4 for EU and ROW).
5. 5) DOUBLE BLIND PHASE: 2-grade improvement on the SSA at MF at each post-treatment visit.
6. 6) DOUBLE BLIND PHASE: 1-grade improvement on the ILA at MF at each post-treatment visit.
7. 7) DOUBLE BLIND PHASE: 1-grade improvement on the SSA at MF at each post-treatment visit.
8. 8) DOUBLE BLIND PHASE: 1-grade improvement on the ILA at rest at each post-treatment visit.
9. 9) DOUBLE BLIND PHASE: ‘Very Satisfied’ or ‘Satisfied’ answer on the SLS at each post treatment visit (except at Week 4 and Week 24 for all regions except United States)
10. 10) DOUBLE BLIND PHASE: Change from baseline in the ageing appearance VAS score of the FACE-Q scale at each post treatment visit.
11. 11) DOUBLE BLIND PHASE: Response as measured by an improvement of at least 10 points from baseline on the Rasch Transformed Score of the FACE-Q Psychological Function Scale at all timepoints (except at Week 4 for EU).
12. 12) DOUBLE BLIND PHASE: Time to onset of treatment response based on participant’s diary (timeframe Days 1 to 8).
13. 13) DOUBLE BLIND PHASE: The time taken for a responder to re-exhibit a severity grade of ‘Moderate’ or ‘Severe’ as measured by the ILA at MF following IMP administration. Note: Responder is defined as having a score of ‘None’ or ‘Mild’ on the ILA
14. 14) DOUBLE BLIND PHASE: Incidence, severity and nature of TEAEs, SAEs or AEs (or SAEs) leading to discontinuations and AESIs (throughout the study duration in the DB Phase).
15. 15) DOUBLE BLIND PHASE: Clinically significant changes in vital signs, ECGs, facial and focused neurological/physical examination compared to baseline (throughout the study duration in the DB Phase).
16. 16) DOUBLE BLIND PHASE: Presence of IPN10200 antibodies and titres (binding and neutralising) at screening, end of W4, W12, W24, W36* and W52 (end of the DB Phase). *At Week 36 only if not eligible for retreatment before.
17. 17) OPEN LABEL PHASE: Multi-component response as measured by a 2-grade improvement and a score of ‘None’ or ‘Mild’ on both the ILA and SSA at MF at each post-treatment visit within each cycle.
18. 18) OPEN LABEL PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the ILA at MF at each post-treatment visit within each cycle.
19. 19) OPEN LABEL PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the SSA at MF at each post-treatment visit within each cycle.
20. 20) OPEN LABEL PHASE: 2-grade improvement and a score of ‘None’ or ‘Mild’ on the ILA at MF at each post-treatment visit within each cycle.
21. 21) OPEN LABEL PHASE: 2-grade improvement and a score of ‘None’ or ‘Mild’ on the SSA at MF at each post-treatment visit within each cycle.
22. 22) OPEN LABEL PHASE: 1-grade improvement on the ILA at MF at each post-treatment visit.
23. 23) OPEN LABEL PHASE: 1-grade improvement on the SSA at MF at each post-treatment visit.
24. 24) OPEN LABEL PHASE: 1-grade improvement on the ILA at rest at each post-treatment visit.
25. 25) OPEN LABEL PHASE: ‘Very Satisfied’ or ‘Satisfied’ answer on the SLS at each post-treatment visit within each cycle.
26. 26) OPEN LABEL PHASE: Change from baseline in the ageing appearance VAS score of the FACE-Q Scale at each post treatment visit within each cycle.
27. 27) OPEN LABEL PHASE: Response as measured by an improvement of at least 10 points from baseline on the Rasch Transformed Score of the FACE-Q Psychological Function Scale at each post treatment visit within each cycle.
28. 28) OPEN LABEL PHASE: The time between two consecutive injections.
29. 29) OPEN LABEL PHASE: Incidence, severity and nature of the TEAEs, SAEs, AEs (or SAEs) leading to discontinuations and AESIs (throughout the study duration in the OL Phase).
30. 30) OPEN LABEL PHASE: Clinically significant changes in vital signs, facial and focused neurological/physical examination compared to baseline (throughout the study duration in the OL Phase).
31. 31) OPEN LABEL PHASE: Presence of IPN10200 antibodies and titres (binding and neutralising) at screening, end of W4, W12, W24, W36*, W52 of each cycle and at EOS. *At Week 36 only if not eligible for retreatment before.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ipsen Innovation

Sponsor organisation

Ipsen Innovation

Address

70 Rue Balard

City

Paris

Postcode

75015

Country

France

Scientific contact point

Organisation

Ipsen Innovation

Contact name

Medical Development Director

Public contact point

Organisation

Ipsen Innovation

Contact name

Ipsen Clinical Study Enquiries

Third parties 4

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications