Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Contracture

Dupuytren Contracture

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

AK160 (Collagenase Clostridium Histolyticum) 0.58 mg

Collagenase Clostridium Histolyticum

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.

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

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

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.

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.

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.

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.

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.

Asahi Kasei Pharma Corporation

Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg

AK160 0.58 mg Step 1-3

This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.

And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.

Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints.

AK160 0.58 mg Step 1

This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.

Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints.

AK160 0.58 mg Step 2

The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.

This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.

Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints.

AK160 0.58 mg Step3

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Japan

Region of Enrollment

Norihiro Tateishi, Manager

collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints

AK160 0.58 mg Step 1-2

The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.

The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"

collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints

Primary MP Joints

collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints

Primary PIP Joints

collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints

The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Collagenase Option for Reduction of Dupuytren's Contracture in Japan	NCT01588353	Dupuytren's Con...	Collagenase Clo...	20 Years -	Asahi Kasei Pharma Corporation
Collagenase Option for Reduction of Dupuytren's Contracture in Japan	NCT01588353	Dupuytren's Con...	Collagenase Clo...	20 Years -	Asahi Kasei Pharma Corporation

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