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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04821089




Registration number
NCT04821089
Ethics application status
Date submitted
26/03/2021
Date registered
29/03/2021

Titles & IDs
Public title
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines
Scientific title
A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults
Secondary ID [1] 0 0
2020-003746-36
Secondary ID [2] 0 0
D-FR-10200-002
Universal Trial Number (UTN)
Trial acronym
LANTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Upper Facial Lines 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - IPN10200
Treatment: Other - IPN10200 Placebo
Treatment: Other - Dysport

Experimental: IPN10200 group - Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee recommendation.

Placebo comparator: Placebo group - Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee recommendation.

Active comparator: Dysport group (stage 1 / step 2 only) -


Treatment: Other: IPN10200
Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region.

Treatment: Other: IPN10200 Placebo
One single injection of study intervention will be injected locally into several sites across the glabellar region.

Treatment: Other: Dysport
Single administration of study intervention in stage 1 / step 2 only
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events (TEAEs) at each dose
Timepoint [1] 0 0
From the baseline to the end of the study (9 months)
Primary outcome [2] 0 0
Incidence of serious adverse events (SAEs) at each dose
Timepoint [2] 0 0
From the baseline to the end of the study (9 months)
Primary outcome [3] 0 0
Incidence of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
Timepoint [3] 0 0
From the baseline to the end of the study (9 months)
Primary outcome [4] 0 0
Response to treatment as measured by the composite response of 2-grade improvement on Investigator's Live Assessment (ILA) at maximum contraction
Timepoint [4] 0 0
At Week 4
Primary outcome [5] 0 0
Response to treatment as measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction
Timepoint [5] 0 0
At Week 4
Primary outcome [6] 0 0
Response to treatment as measured by the composite response of 2-grade improvement on ILA at maximum contraction on the forehead lines (FHL) area
Timepoint [6] 0 0
At Week 4
Primary outcome [7] 0 0
Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the forehead lines (FHL) area
Timepoint [7] 0 0
At Week 4
Primary outcome [8] 0 0
Response to treatment as measured by the composite response of 2-grade improvement ILA at maximum contraction on the lateral canthal lines (LCL) area
Timepoint [8] 0 0
At Week 4
Primary outcome [9] 0 0
Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the LCL area
Timepoint [9] 0 0
At Week 4
Secondary outcome [1] 0 0
Response to treatment measured by the composite response of 2-grade improvement on ILA
Timepoint [1] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [2] 0 0
Response to treatment measured by the composite response of 2-grade improvement on SSA
Timepoint [2] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [3] 0 0
Response to treatment as measured by the reduction of =2 grades on the ILA at maximum contraction
Timepoint [3] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [4] 0 0
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction
Timepoint [4] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [5] 0 0
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest
Timepoint [5] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [6] 0 0
Response to treatment as measured by the reduction of =2 grades on the SSA at maximum contraction
Timepoint [6] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [7] 0 0
Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction
Timepoint [7] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [8] 0 0
Response to treatment as achieved by a score of "very satisfied" or "satisfied" on the Subject Level of Satisfaction (SLS)
Timepoint [8] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [9] 0 0
Duration of treatment response based on ILA and SSA at maximum contraction
Timepoint [9] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [10] 0 0
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines
Timepoint [10] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [11] 0 0
Satisfaction with facial appearance scale score on the Face-Q satisfaction scale
Timepoint [11] 0 0
From the baseline to the end of the study (9 months)
Secondary outcome [12] 0 0
Incidence, severity and nature of treatment emergent adverse events (TEAEs)
Timepoint [12] 0 0
From baseline to the end of the study (9 months)
Secondary outcome [13] 0 0
Incidence, severity and nature of serious adverse events (SAEs)
Timepoint [13] 0 0
From baseline to the end of the study (9 months)
Secondary outcome [14] 0 0
Incidence, severity and nature of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
Timepoint [14] 0 0
From baseline to the end of the study (9 months)
Secondary outcome [15] 0 0
Presence of IPN10200 antibodies and titres (binding and neutralizing)
Timepoint [15] 0 0
At Week 4 , Week 24 and Week 36
Secondary outcome [16] 0 0
Presence of BoNT-A antibodies and titres (binding and neutralizing)
Timepoint [16] 0 0
At Week 4 , Week 24 and Week 36

Eligibility
Key inclusion criteria
1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
2. Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
3. Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
4. Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the SLS.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. An active infection or other skin problems in the upper face including the GL, FHL, and LCL area (e.g. acute acne lesions or ulcers).
2. A history of eyelid blepharoplasty or brow lift within the past 5 years
3. A history of facial nerve palsy.
4. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
5. 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.)
6. Has COVID-19 illness or a know positive SARS-CoV-2 test, or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function)
7. Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recent reatment (within the past 6 months prior to baseline) with any BoNT serotype for Stage 1 / Step 2.
8. Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
9. Any prior treatment with long lasting dermal fillers in the upper face including the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the 12 months prior to Baseline.
10. Any planned facial cosmetic surgery during the study.
11. Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
12. Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline.
13. 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 halflife is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
14. Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
15. 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
16. An inability to substantially lessen GL and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator.
17. Known allergy or hypersensitivity to BoNT or any excipients of IPN10200 or Dusport/Azzalure, or allergy to cow's milk protein.
18. A history of drug or alcohol abuse
19. Pregnant women, nursing women, premenopausal women or women of childbearing potential not willing to practice a highly effective form of contraception method
20. Male participants who are not vasectomized and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/03/2027
Actual
Sample size
Target
727
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Antibes
Country [2] 0 0
France
State/province [2] 0 0
Lyon
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Darmstadt
Country [6] 0 0
Germany
State/province [6] 0 0
Düsseldorf
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Germany
State/province [8] 0 0
Mahlow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ipsen Recruitment Enquiries
Address 0 0
Country 0 0
Phone 0 0
see email
Fax 0 0
Email 0 0
clinical.trials@ipsen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04821089