Collagenase Option for Reduction of Dupuytren's Contracture in Japan (CORD-J)

Phase III Study of AK160 in Patients With Dupuytren's Contracture

To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.

To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture.

Study Overview

• Status: Completed
• Conditions: Dupuytren's Contracture
• Intervention / Treatment: Drug: Collagenase Clostridium Histolyticum

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
  • Aomori, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Hiroshima, Japan
  • Hokkaido, Japan
  • Ishikawa, Japan
  • Iwate, Japan
  • Kanagawa, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Mie, Japan
  • Nagano, Japan
  • Nagasaki, Japan
  • Niigata, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Tokushima, Japan
  • Tokyo, Japan
  • Yamaguchi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 20 years old when written informed consent is obtained.
• Having a diagnosis of Dupuytren's contracture and flexion contracture due to palpable cord in at least 1 non-thumb finger (20° to 100° in MP joint and 20° to 80° in PIP joint).
• Positive tabletop test result (i.e., cannot simultaneously place affected finger and palm on a table).
• Voluntary written informed consent is obtained.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

• Is pregnant, may be pregnant, wishes to become or could become pregnant during the study (i.e., unless acceptable contraception is used, the patient has been sterilized, or the patient is postmenopausal [no menstrual period for at least 12 months without any other medical cause]), or is breastfeeding.
• Has a coexisting chronic disease of the hand that could impact assessment (muscular disease, neurological disease, neuromuscular disease).
• Has received another investigational product 30 or fewer days before first injection of the investigational product.
• Has undergone aponeurectomy, aponeurotomy, needle aponeurotomy/fasciotomy, verapamil/interferon injection, or another Dupuytren's Contracture treatment of the primary joint 90 or fewer days before first injection of the investigational product.
• Is allergic to collagenase or any of the excipients of AK160.
• Has taken tetracycline derivative such as minocycline and doxycycline 14 or fewer days before first injection of the investigational product.
• Has received a collagenase product 30 or fewer days before first injection of the investigational product.
• Is currently taking or has taken, 7 or fewer days before first injection of the investigational product, an anticoagulant or antiplatelet drug (other than ≤150 mg/day of aspirin).
• Has suffered a recent stroke, hemorrhage, or other disease affecting the hands.
• Has a serious disease unsuited for the study.
• Receiving treatment for a malignancy.
• History of drug or alcohol addiction within the past 5 years or history of drug or alcohol abuse within the past year.
• Has received previously the investigational product (AK160, AA4500, XIAFLEX®, or XIAPEX®).
• Otherwise found ineligible as a subject by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK160 0.58 mg	Drug: Collagenase Clostridium Histolyticum; AK160 (Collagenase Clostridium Histolyticum) 0.58 mg; Other Names: Xiaflex® (US); Xiapex® (EU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"	The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where "successfully treated" was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times.	30 days after the last injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement After the Last Injection	The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where "clinically improved" was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times.	30 days after the last injection
Percent Reduction From Baseline Contracture After the Last Injection	The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.	30 days after last treatment
Change From Baseline Range of Motion After the Last Injection	The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.	30 days after last treatment
Time to First Achieve and Maintain Clinical Success After the Last Injection	The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where "clinical success" was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times.	First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months

Collaborators and Investigators

• Sponsor: Asahi Kasei Pharma Corporation

Publications and helpful links

General Publications

• Hirata H, Tanaka K, Sakai A, Kakinoki R, Ikegami H, Tateishi N. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population. J Hand Surg Eur Vol. 2017 Jan;42(1):30-38. doi: 10.1177/1753193416653249. Epub 2016 Sep 28.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: AK160, collagenase clostridium histolyticum
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: AK160-III-1