A Phase I/II safety and efficacy study of Vibrio alginolyticus collagenase in patients with Peyronie’s Disease A Phase I single ascending dose with a Phase II expansion, safety, tolerability, efficacy, pharmacokinetics and immunogenicity study

Peyronie’s Disease

PHASE I PART - ENDPOINTS: Overall safety and tolerability profile of each tested escalating dose of V. alginolyticus collagenase in order to identify the Maximum Tolerated Dose., PHASE II PART - ENDPOINTS: Percentage of reduction in maximal penile curvature deformity as change from baseline at 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (Day 169±2) for Dose regimen B. Penile curvature will be measured using a goniometer protractor device, after alprostadil induction of an erection.

PHASE I PART - ENDPOINTS: Overall change in symptoms and effects of Peyronie’s Disease on patients’ lives, evaluated using the Global Assessment of Peyronie’s Disease 29±2 days after the injection of V. alginolyticus collagenase into the penile plaque., PHASE I PART - ENDPOINTS: Evaluation of the change from baseline in total penile discomfort assessed 29±2 days after the injection of V. alginolyticus collagenase into the penile plaque., PHASE I PART - ENDPOINTS: Blood exposure, evaluated as serum levels of collagenase at pre-dose and at 0.5, 1, 2 and 4 h post-dose after each tested escalating dose of V. alginolyticus collagenase., PHASE I PART - ENDPOINTS: Immunogenicity, evaluated through assay of serum anti-drug antibodies (ADA) and neutralising antibodies (nAb) at pre-dose and at 29±2 days after each tested escalating dose of V. alginolyticus., PHASE II PART - ENDPOINTS: Overall change in symptoms and effects of Peyronie’s Disease on patients’ lives, using the Global Assessment of Peyronie’s Disease assessed 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (last injection; Day 169±2) for Dose regimen B, of V. alginolyticus collagenase into the penile plaque., PHASE II PART - ENDPOINTS: Overall Satisfaction Domain of the IIEF-5 scores, assessed 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (last injection; Day 169±2) for Dose regimen B, of V. alginolyticus collagenase into the penile plaque, will be summarised as proportion of subjects for each score., PHASE II PART - ENDPOINTS: Penile plaque consistency scores, assessed 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A up to the follow-up visit month 6±15 days and 42±2 days after the 8th injection (last injection; Day 169±2) up to the follow-up visit month 6±15 days for Dose regimen B, of V. alginolyticus collagenase into the penile plaque, will be summarised as proportion of subjects for each score., PHASE II PART - ENDPOINTS: Evaluation of the change from baseline in total penile discomfort assessed 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (last injection; Day 169±2) for Dose regimen B of V. alginolyticus collagenase into the penile plaque., PHASE II PART - ENDPOINTS: Proportion of composite responders defined as patients with a percentage reduction from baseline 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (Day 169±2) for Dose regimen B in maximal penile curvature of ≥20% and a change from not being able to have a sexual intercourse at screening to having sexual intercourses during the study., PHASE II PART - ENDPOINTS: Change from baseline in penile length (long side length, short side length), circumference measured at the maximum curvature point, maximal penile curvature measured by goniometry and with respect to penile hemodynamic parameters assessed 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (last injection; Day 169±2) for Dose regimen B, of V. alginolyticus collagenase into the penile plaque, during penile physical exam., PHASE II PART - ENDPOINTS: Change from baseline for all items of the MSHQ assessed 29±2 days after the 3rd injection (Day 88±2) for Dose regimen A and 42±2 days after the 8th injection (last injection; Day 169±2) for Dose regimen B, of V. alginolyticus collagenase into the penile plaque., PHASE II PART - ENDPOINTS: Overall safety and tolerability profile following each injection of V. alginolyticus collagenase [Treatment-Emergent Adverse Events; vital signs (blood pressure, pulse rate), physical examinations; laboratory tests; ECGs]., PHASE II PART - ENDPOINTS: Blood exposure, evaluated as serum levels of collagenase at pre-dose and 0.5, 1, 2 and 4 h post-dose after each injection (Days 1, 30±2 and 59±2) for Dose regimen A and after the second injection of each treatment cycle (24-72 h after the first injection of each treatment cycle) for Dose regimen B of V. alginolyticus collagenase., PHASE II PART - ENDPOINTS: Immunogenicity, evaluated through assay of serum anti-drug antibodies (ADA) and neutralising antibodies (nAb) in all subjects, at pre-dose and at 29±2 days after last injection (Day 88±2) for Dose regimen A, and at 42±2 days after both the 4th and 8th injections (Days 85±2 and 169±2) for Dose regimen B.

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