A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Seve… (NCT04821089) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines
France, Germany727 participantsStarted 2021-04-06
Plain-language summary
The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines.
This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants.
Stage 1 (phase Ib \& II)
* Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
* Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport
* Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of IPN10200. In the OL phase, participants may receive repeat administrations of IPN10200 for up to three additional cycles (up to four treatment cycles in total during the study).
Stage 2 (phase II) - An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL)
Stage 3 (phase II)
\- A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
✓. Moderate or severe (Grade 2 or 3) GL (Stage 1) 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 (Stage 1) at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
✓. Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
✓. Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
✓. Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction as assessed by the SSA using a 4-point photographic scale.
✓. Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction, as assessed by the SSA using a 4-point photographic scale.
What they're measuring
1
Incidence of treatment emergent adverse events (TEAEs) at each dose
Timeframe: From the baseline to the end of the study (9 months)
2
Incidence of serious adverse events (SAEs) at each dose
Timeframe: From the baseline to the end of the study (9 months)
3
Incidence of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
Timeframe: From the baseline to the end of the study (9 months)
4
Response to treatment as measured by the composite response of 2-grade improvement on Investigator's Live Assessment (ILA) at maximum contraction
Timeframe: At Week 4
5
Response to treatment as measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction
Timeframe: At Week 4
6
Response to treatment as measured by the composite response of 2-grade improvement on ILA at maximum contraction on the forehead lines (FHL) area
Timeframe: At Week 4
7
Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the forehead lines (FHL) area
✓. Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines (Stages 1 to 3) at Baseline, as assessed by the SLS.
Exclusion criteria
✕. 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).
✕. A history of eyelid blepharoplasty or brow lift within the past 5 years
✕. A history of facial nerve palsy.
✕. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
✕. 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.)
✕. Has COVID-19 illness or a known positive SARS-CoV-2 test (Stage 1), or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function)
✕. Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recent treatment (within the past 9 months prior to baseline) with any BoNT serotype for Stage 1 / Step 2, Stage 1/Step 3, Stages 2 and 3. Participants treated in earlier Stages/Steps of the study must not be included in any later Stages/Steps.
✕. Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
Timeframe: At Week 4
8
Response to treatment as measured by the composite response of 2-grade improvement ILA at maximum contraction on the lateral canthal lines (LCL) area
Timeframe: At Week 4
9
Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the LCL area