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AA4500 collagenase clostridium histolyticum

Phase 3

Dupuytren's Contracture | Monoclonal antibody | Musculoskeletal |BrainsWay Ltd.|Last Updated: Oct 5, 2017

Success Probability

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

AA4500 collagenase clostridium histolyticum · 1 trial · 1 indication

Phase 3 1
NCT01407068Administration of Two Injections for Multiple Dupuytren's ContracturesDupuytren's Contracture
COMPLETED60 Analytics
PHASE3COMPLETED
Administration of Two Injections for Multiple Dupuytren's Contractures
Dupuytren's ContractureUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Total Fixed Flexion
30 days after last injection

Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees

Change in Total Range of Motion
30 days after last injection

The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.

Secondary Endpoints

Subject Satisfaction With Treatment
60 days after last injection
Investigator Assessment of Improvement With Treatment
60 days after last injection
Clinical Success by Joint Type
30 days after injection
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AA4500EXPERIMENTALAA4500 collagenase clostridium histolyticum

Interventions

NameTypeDescription
AA4500 collagenase clostridium histolyticumBIOLOGICAL2 concurrent injections (0.58 mg) into 2 cords on the same hand
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Provide written informed consent 2. Be a man or woman ≥ 18 years of age 3. Have a diagnosis of Dupuytren's disease and have at least 2 fixed-flexion contractures on the same hand that are ≥ 20º in PIP and/or MP joints in fingers, other than the thumbs, which are caused by pal...

Countries:United StatesAustralia
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Frequently asked questions about AA4500 collagenase clostridium histolyticum

What is AA4500 collagenase clostridium histolyticum used for?

AA4500 collagenase clostridium histolyticum is used for the treatment of Dupuytren's Contracture, a condition affecting the hand. It is a monoclonal antibody being developed for this musculoskeletal indication. The drug is currently in Phase 3 clinical development.

Who makes AA4500 collagenase clostridium histolyticum?

AA4500 collagenase clostridium histolyticum is being developed by BrainsWay Ltd., a company listed on the stock exchange under the ticker BWAY. The drug is currently in Phase 3 clinical development for the treatment of Dupuytren's Contracture.

What phase is AA4500 collagenase clostridium histolyticum in?

AA4500 collagenase clostridium histolyticum is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of Dupuytren's Contracture. The drug has completed one Phase 3 trial and is not yet approved.

What clinical trials is AA4500 collagenase clostridium histolyticum in?

AA4500 collagenase clostridium histolyticum has been studied in a Phase 3 clinical trial with the identifier NCT01407068. This trial, titled 'Administration of Two Injections for Multiple Dupuytren's Contractures,' was completed and enrolled 60 participants in the United States and Australia.

How does AA4500 collagenase clostridium histolyticum work?

AA4500 collagenase clostridium histolyticum is a monoclonal antibody. It is being developed for the treatment of Dupuytren's Contracture, a musculoskeletal condition. The drug is currently in Phase 3 clinical development.