A Study of AA4500 in Men With Peyronie's Disease

NCT01243411 | Completed Phase 3 Results

• 1 other identifier: AUX-CC-802
• Study Type: interventional
• Target: 348
• Locations: 9 countries
• Sites: 39

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. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.

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 at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)

Also known as: XIAFLEX

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 receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must:
• Be a male and be ≥ 18 years of age
• Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse
• Have symptom(s) of Peyronie's disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator
• 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
• 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 or the appropriate local language for the country in which the study is being performed.

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
• 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

Study Sites (39)

Urology Associates Medical Group

Burbank, California, 91505, United States

Location

Connecticut Clinical Research Center, LLC

Middlebury, Connecticut, 06762, United States

Location

The Urology Center, P.C.

New Haven, Connecticut, 06511, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Urology Specialists, S.C.

Chicago, Illinois, 60612, United States

Location

Northeast Indiana Research, LLC

Fort Wayne, Indiana, 46825, United States

Location

Metropolitan Urology, P.S.C.

Jeffersonville, Indiana, 47130, United States

Location

Maimonides Medical Center, Division of Urology

Brooklyn, New York, 11219, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

Tristate Urologic Services PSC, Inc./ dba TUG Research

Cincinnati, Ohio, 45212, United States

Location

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Urology of Virginia-Sentara Medical Group

Norfolk, Virginia, 23502, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Aarhus Universitiy Hospital, Aalborg Sygehus

Aalborg, DK-9100, Denmark

Location

Frederiksberg Hospital

Frederiksberg, DK-2000, Denmark

Location

Frederikssunds Hospital

Frederikssund, DK-3600, Denmark

Location

Klinik for seksuelle dysfunktioner

Gentofte Municipality, DK-2820, Denmark

Location

Centre Hospitalier Edouar Herriot

Lyon, F-69 437, France

Location

Hopital Henri Gabrielle

Saint-Genis-Laval, F-69230, France

Location

Universitatsklinikum Freiburg, Abteilung Urologie

Freiburg im Breisgau, DE-79106, Germany

Location

Private Practice of Urology/Andrology

Hamburg, DE-20354, Germany

Location

Uro-Onkologische Praxis Dr. von Keitz

Marburg, DE-35039, Germany

Location

Urologische Gemeinschaftspraxis Reutlingen

Reutlingen, DE-72764, Germany

Location

Universitatsklinikum Tubingen

Tübingen, DE-72096, Germany

Location

University of Naples "Federico II"

Naples, I-80131, Italy

Location

Universitiy Tor Vergatat of Rome

Rome, I-00133, Italy

Location

Waitemata Urology Research North Shore Hospital

Takapuna, Auckland, 0622, New Zealand

Location

Tauranga Urology Research Ltd.

Tauranga, Bay of Plenty, 3140, New Zealand

Location

Primorus Clinical Trials Ltd.

Christchurch, Canterbury, 8011, New Zealand

Location

CURT Medical Trials Trust Board Inc.

Christchurch, Canterbury, 8014, New Zealand

Location

Cardinal Points Research Ltd.

Whangarei, Northland, 0112, New Zealand

Location

Wellington Urology Associates

Wellington South, Wellington Region, 6021, New Zealand

Location

Hospital Clinic de Barcelona

Barcelona, ES-08036, Spain

Location

Hospital La Zarzuela

Madrid, ES-28043, Spain

Location

Specialistmottagningen i urologi

Gothenburg, SE-405 45, Sweden

Location

Carlshamns Specialistklinik

Karlshamn, SE-374 35, Sweden

Location

Akademiska Sjukhuse

Uppsala, SE-751 85, Sweden

Location

St. Peter's Andrology Centre

London, W1G 6BJ, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 &TP, United Kingdom

Location

Related Publications (1)

• Levine LA, Cuzin B, Mark S, Gelbard MK, Jones NA, Liu G, Kaufman GJ, Tursi JP, Ralph DJ. Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. J Sex Med. 2015 Jan;12(1):248-58. doi: 10.1111/jsm.12731. Epub 2014 Nov 12.

  PMID: 25388099 DERIVED

MeSH Terms

Conditions

Penile Induration

Interventions

Microbial Collagenase

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 J. 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: November 17, 2010
• First Posted: November 18, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 5, 2017
• Results First Posted: April 15, 2015

Record last verified: 2017-09

Locations

DE (5); US (13); NZ (6); ES (2); IT (2); SE (3); DK (4); FR (2); GB (2)