A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease

NCT01685437 | Completed Phase 3 Results

• 1 other identifier: AUX-CC-806
• Study Type: interventional
• Target: 189
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Enrollment will include all subjects who meet the eligibility criteria and who received placebo and completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.

Conditions

Peyronie's Disease

Keywords

Peyronie's disease, penile plaque, penile curvature

Outcome Measures

Primary Outcomes (2)

• Percentage Change From Baseline in Penile Curvature

  A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.

  Baseline and Week 36

• Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)

  Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.

  Baseline and Week 36

Secondary Outcomes (7)

• Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ

  Baseline and Week 36

• Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4

  Baseline and Week 36

• A Responder Analysis Based on Subject Overall Global Assessment

  Week 36

• Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)

  Baseline and Week 36

• Change From Baseline in Penile Plaque Consistency

  Baseline and Week 36

Study Arms (1)

AA4500

EXPERIMENTAL

collagenase clostridium histolyticum

Biological: AA4500

Interventions

AA4500 BIOLOGICAL

2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Also known as: Xiaflex, Xiapex

AA4500

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who completed their participation in Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804 and received placebo in that study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must:
• Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study
• Be judged to be in good health, based upon the results of a medical history, physical examination,and laboratory profile
• Have participated in Study AUX-CC-803 or Study AUX-CC-804, received placebo in that study,and completed that study
• Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
• Be able to read, complete and understand the various rating instruments in English.

You may not qualify if:

• A subject will be excluded from study participation if he:
• Has a penile curvature of less than 30° or greater than 90° at the screening visit
• Has any of the following conditions:
• Chordee in the presence or absence of hypospadias
• Thrombosis of the dorsal penile artery and/or vein
• Infiltration by a benign or malignant mass resulting in penile curvature
• Infiltration by an infectious agent, such as lymphogranuloma venereum
• Ventral curvature from any cause
• Presence of an active sexually transmitted disease
• Known active hepatitis B or C
• Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
• Has previously undergone surgery for Peyronie's disease
• Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity after administration of prostaglandin E1 or trimix or another suitable injectable pharmacologic stimulant according to the standard practice at the investigator's institution
• Has an isolated hourglass deformity of the penis
• Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

MeSH Terms

Conditions

Penile Induration

Interventions

Microbial Collagenase; xiapex

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Gregory Kaufman, MD

  Auxilium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 5, 2017
• Results First Posted: April 7, 2015

Record last verified: 2017-09