Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules

Summary

The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.

Timeline

Start

2014-07

Primary completion

2014-12

Completion

2014-12

Outcome

Mixed primary results

registry analysis (superiority or other test); AA4500 0.60 mg vs Placebo; p <.0001; ANOVA NCT02193828 ↗

registry analysis (superiority or other test); AA4500 0.25 mg vs Placebo; p = .0713; ANOVA NCT02193828 ↗

registry analysis (superiority or other test); AA4500 0.25 mg vs Placebo; p = .0446; ANOVA NCT02193828 ↗

Publications

• Costas B, Coleman S, Kaufman G, James R, Cohen B, Gaston RG. Efficacy and safety of collagenase clostridium histolyticum for Dupuytren disease nodules: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Aug 30;18(1):374. doi: 10.1186/s12891-017-1713-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Collagenase Clostridium Histolyticum	Protein / enzyme biologic	0.25 mg	Other
Subject	Collagenase Clostridium Histolyticum	Protein / enzyme biologic	0.4 mg	Other
Subject	Collagenase Clostridium Histolyticum	Protein / enzyme biologic	0.6 mg	Other

Indications