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Phase I/II study to evaluate the efficacy and safety of bacterial collagenase administered in patients with Peyronie's Disease
EU CTIS ID: 2023-509621-45-00
What this study is testing
PHASE I PART - OBJECTIVE Primary objective To evaluate the safety and tolerability profile of each tested escalating dose as a single injection of V. alginolyticus collagenase injected into the plaque causing a deformity of the penis of patients with the Peyronie’s Disease in order to identify the Maximum Tolerated Dose. PHASE II PART - OBJECTIVE Primary objective To assess the efficacy of the Maximum Tolerated Dose identified in Phase I part in terms of percentage improvement from baseline (screening assessment) in maximal penile curvature.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed Consent: signed written informed consent before inclusion in the study.
- Sex and Age: men subjects ≥18 year of age.
- Peyronie’s Disease: diagnosis of Peyronie’s Disease for at least 12 months, in the absence of pain (during erection) before the first dose of study drug, having a stable curvature deformity between 30° and 90° in the dorsal, lateral, or dorsal/lateral plane at screening (without any change in the deformity for at least 1 year), and an IIEF-5 score ≥17.
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study including conduction of vacuum assisted penile stretching and manual modelling exercises.
- Relationship: stable relationship with a partner for at least 3 months before screening and be willing to have sexual intercourse with that partner who does not have issues in guaranteeing compliance with the study (e.g. pregnancy, endometriosis, vulvodynia).
- Contraception and fertility a. sexual abstinence for 15 days after injections in the Phase I part only b. sexual abstinence for 15 days (after each of the three injections for Dose regimen A and after each of the 4 treatment cycles for Dose regimen B) in Phase Part II and c. if having a female sexual partner of childbearing potential, must agree to use a male condom or d. must confirm to have a sterile sexual partner.
You likely can't join if
- Curvature: curvature deformity of <30° or >90° or ventral curvature from any cause, at the screening visit.
- Allergy: ascertained or presumptive hypersensitivity to collagenase or investigational product excipients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study. Known hypersensitivity to alprostadil or to any of the excipients of alprostadil based medicinal product.
- Diseases: significant history of cardiovascular, skin, endocrine or neurological diseases or of active sexually transmitted diseases or of any other medical condition which may interfere with the aim of the study (including clinically significant abnormal ECG).
- Pain perception: Limited or no pain perception, e.g. in the case of paraplegia or polyneuropathy (contraindication for vacuum assisted penile stretching).
- Virology: known active hepatitis B or C, known immune deficiency disease (including human immunodeficiency virus [HIV]).
- Medications: intake of tetracycline or their derivatives within 14 days before the screening.
See the full eligibility criteria
Who can join
- Informed Consent: signed written informed consent before inclusion in the study.
- Sex and Age: men subjects ≥18 year of age.
- Peyronie’s Disease: diagnosis of Peyronie’s Disease for at least 12 months, in the absence of pain (during erection) before the first dose of study drug, having a stable curvature deformity between 30° and 90° in the dorsal, lateral, or dorsal/lateral plane at screening (without any change in the deformity for at least 1 year), and an IIEF-5 score ≥17.
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study including conduction of vacuum assisted penile stretching and manual modelling exercises.
- Relationship: stable relationship with a partner for at least 3 months before screening and be willing to have sexual intercourse with that partner who does not have issues in guaranteeing compliance with the study (e.g. pregnancy, endometriosis, vulvodynia).
- Contraception and fertility a. sexual abstinence for 15 days after injections in the Phase I part only b. sexual abstinence for 15 days (after each of the three injections for Dose regimen A and after each of the 4 treatment cycles for Dose regimen B) in Phase Part II and c. if having a female sexual partner of childbearing potential, must agree to use a male condom or d. must confirm to have a sterile sexual partner.
What rules you out
- Curvature: curvature deformity of <30° or >90° or ventral curvature from any cause, at the screening visit.
- Allergy: ascertained or presumptive hypersensitivity to collagenase or investigational product excipients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study. Known hypersensitivity to alprostadil or to any of the excipients of alprostadil based medicinal product.
- Diseases: significant history of cardiovascular, skin, endocrine or neurological diseases or of active sexually transmitted diseases or of any other medical condition which may interfere with the aim of the study (including clinically significant abnormal ECG).
- Pain perception: Limited or no pain perception, e.g. in the case of paraplegia or polyneuropathy (contraindication for vacuum assisted penile stretching).
- Virology: known active hepatitis B or C, known immune deficiency disease (including human immunodeficiency virus [HIV]).
- Medications: intake of tetracycline or their derivatives within 14 days before the screening.
- Investigative drug studies: participation in the evaluation of any investigational product for 30 days before this study and until the follow-up visit at 6 months.
- Blood donation: blood donations for 3 months before this study.
- Sexual intercourse: subjects not engaging in sexual intercourse within 3 months prior to screening .
- No comprehension: INABILITY to comprehend the full nature and purpose of the study, possible risks and side effects; INABILITY to co-operate with the Investigator and to comply with the requirements of the entire study including vacuum assisted penile stretching and home modelling exercises.
- Underlying penis pathology: any condition affecting the penis, such as chordee in the presence or absence of hypospadias, thrombosis of the dorsal penile artery, infiltration by a benign or malignant mass or an infectious agent, significant erectile dysfunction that had failed to respond to oral treatment with phosphodiesterase type 5 inhibitors, priapism.
- Curvature Measurement: failing erection that, in the opinion of the Investigator, is insufficient to accurately measure the subject’s penile deformity after administration of a prostaglandin E1-like drug (alprostadil).
- Calcified Plaque: calcified plaque, as evident by appropriate penile ultrasound preventing a proper injection of the study treatment, with the exclusion of a non-contiguous stippling of calcium, provided that calcium deposit does not interfere with the injection of collagenase into the plaque; Peyronie’s plaques that involve the penile urethra, due to potential risk to this structure.
- Hourglass Deformity: isolated hourglass deformity of the penis.
- Proximal Plaque: plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anaesthetic could interfere with the injection of collagenase into the plaque.
- Peyronie’s Disease treatments: receiving or planning to undergo any other treatment of the Peyronie’s Disease during the study period and until the follow-up visit at 6 months, including but not limited to any surgery before the study, oral/topical agents within 3 months, intralesional medical therapies within 3 months, extracorporeal shock wave therapy within 6 months, use of mechanical devices within 2 weeks before the screening visit.
- Baseline Hemodynamic: a penile duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamic that, in the opinion of the Investigator, is clinically significant.
- Bleeding and anticoagulants: history of bleeding, coagulation disorders, anticoagulant or antiaggregant therapy within 7 days of the screening with the exception of low daily intake of acetylsalicylic acid (100 mg/die).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.