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About
The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.
Full description
Approximately 13 sites in the United States and Australia, approximately 90 study subjects.
After all pre-injection procedures are completed on day 1, eligible men and women will be randomized in a 1:1:1 ratio to dose group and then in a 4:1 ratio to treatment group. Study drug will be administered into a palmar nodule located on the selected hand.
AA4500 (collagenase clostridium histolyticum) 3 doses (low, medium, and high) after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization.
Placebo after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization.
Follow up visits for the evaluation of safety and efficacy will be required for all subjects on days 8, 29, and 57.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Provide a signed and dated informed consent
Be a man or woman ≥ 18 years of age
Have a diagnosis of Dupuytren's disease AND have at least one palmar nodule on the selected hand that is:
Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, < 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
Be able to comply with the study visit schedule as specified in the protocol
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
76 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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