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.

Condition studied

Treatment of moderate to severe glabellar lines

Investigational medicinal product(s)

Eligibility

Primary endpoint

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) For EU and ROW: An improvement of at least 2 grades from baseline at Week 4 on the ILA at MF.

Endpoint detail

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) 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) 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) 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) DOUBLE BLIND PHASE: 2-grade improvement on the SSA at MF at each post-treatment visit., 6) DOUBLE BLIND PHASE: 1-grade improvement on the ILA at MF at each post-treatment visit., 7) DOUBLE BLIND PHASE: 1-grade improvement on the SSA at MF at each post-treatment visit., 8) DOUBLE BLIND PHASE: 1-grade improvement on the ILA at rest at each post-treatment visit., 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) DOUBLE BLIND PHASE: Change from baseline in the ageing appearance VAS score of the FACE-Q scale at each post treatment visit., 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) DOUBLE BLIND PHASE: Time to onset of treatment response based on participant’s diary (timeframe Days 1 to 8)., 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) 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) 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) 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) 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) 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) 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) 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) 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) OPEN LABEL PHASE: 1-grade improvement on the ILA at MF at each post-treatment visit., 23) OPEN LABEL PHASE: 1-grade improvement on the SSA at MF at each post-treatment visit., 24) OPEN LABEL PHASE: 1-grade improvement on the ILA at rest at each post-treatment visit., 25) OPEN LABEL PHASE: ‘Very Satisfied’ or ‘Satisfied’ answer on the SLS at each post-treatment visit within each cycle., 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) 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) OPEN LABEL PHASE: The time between two consecutive injections., 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) 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) 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.