TerminatedPhase 1

Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines.

Stopped: Sponsor terminated the study due to strategic considerations

Germany56 participantsStarted 2021-02-10

Plain-language summary

The purpose of the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provision of written informed consent prior to any study related procedures. * Female and male subjects between 18 and 65 years of age, inclusive (for dose escalation females only) * 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. * 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. * Moderate or severe (Grade 2 or 3) Forehead Lines (FHL) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) Lateral Canthal Lines (LCL) at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale). * Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale). * Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the by the SSA using a validated 4-point categorical scale. * Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation

Timeframe: from baseline until the end of study (9 months)

Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation

Timeframe: from baseline until the end of study (9 months)

Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation

Timeframe: from baseline until the end of study (9 months)

Incidence of AEs (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) for dose escalation

Timeframe: from baseline until the end of study (9 months)

Presence of botulinum neurotoxin serotype A (BoNT-A) antibodies and IPN59011 antibodies and titres (binding and neutralizing)

Timeframe: from baseline until the end of study (9 months)

Response to treatment measured by the composite response of 2-grade improvement on investigator's live assessment (ILA) at maximum contraction.

Timeframe: Day 29

Trial details

NCT IDNCT04736745

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-28

View on ClinicalTrials.gov More Moderate Upper Facial Lines trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation

Timeframe: from baseline until the end of study (9 months)

Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation

Timeframe: from baseline until the end of study (9 months)

Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation

Timeframe: from baseline until the end of study (9 months)

Incidence of AEs (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) for dose escalation

Timeframe: from baseline until the end of study (9 months)

Presence of botulinum neurotoxin serotype A (BoNT-A) antibodies and IPN59011 antibodies and titres (binding and neutralizing)

Timeframe: from baseline until the end of study (9 months)

Response to treatment measured by the composite response of 2-grade improvement on investigator's live assessment (ILA) at maximum contraction.

Timeframe: Day 29