Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture
Intervention: Collagenase clostridium histolyticum; Placebo
Intervention description: Single injection into nodule; Single injection into nodule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dupuytren's nodules

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Provide a signed and dated informed consent

          2. Be a man or woman ≥ 18 years of age

          3. Have a diagnosis of Dupuytren's disease AND have at least one palmar nodule on the
             selected hand that is:

               1. Palpable

               2. Measures between 0.5 cm and 2.0 cm in length and between 0.5 cm and 2.0 cm in
                  width using hand-held calipers n

               3. Not directly associated with a Dupuytren's cord

          4. 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)

          5. Be able to comply with the study visit schedule as specified in the protocol

        Exclusion Criteria:

          1. Received steroid injections (eg, tri-amcinolone acetonide) on the selected nodule
             within 3 months before administration of study drug

          2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands

          3. Has a known systemic allergy to collagenase or any other excipient of AA4500

          4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®)
             within 30 days before injection of study drug in the hand selected for treatment

          5. Is currently receiving or plans to receive anticoagulant medication or has received
             anticoagulant medication (except for ≤ 150 mg aspirin daily) within 7 days before
             injection of study drug

          6. Has a known recent history of stroke, bleeding, or other medical condition, which in
             the investigator's opinion would make the subject unsuitable for enrollment in the
             study

          7. Received an investigational drug within 30 days before injection of study drug

          8. Is pregnant or intends on becoming pregnant during the study or is breastfeeding a
             child

          9. Has any clinically significant medical history or condition(s), including conditions
             that affect the hands, that would, in the opinion of the investigator, substantially
             increase the risk associated with the subject's participation in the protocol or
             compromise the scientific objectives of the study

         10. Had surgery on the selected hand within 3 months before the screening visit

         11. Has jewelry on the hand to be treated that cannot be removed