BridgeMD
Phase I/II study to evaluate the efficacy and safety of bacterial collagenase administered in patients with Dupuytren's contracture.
EU CTIS ID: 2023-507332-20-00
What this study is testing
Primary objective in the Phase I part: -To evaluate the safety and tolerability profile of each tested escalating dose of V. alginolyticus collagenase following one injection into the affected cord in the primary joint (MP or PIP) in order to identify the maximum tolerated dose in the absence of limiting toxicity as defined for the dose escalating process and that will be tested in the Phase II part Primary objective in the Phase II part: -To evaluate the efficacy of the dose identified in Phase I part, following up to three injections of V. alginolyticus collagenase into the affected cord in terms of clinical success (expanded cohort) as compared to matching placebo
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men/women, ≥18 year old inclusive
- Dupuytren contracture: diagnosis of Dupuytren contracture with a fixed flexion deformity ≥20° and ≤100°, if in a MP joint, or ≥20° and ≤80°, if in a PIP joint, of at least one finger, other than the thumb, caused by a palpable cord that, according to the investigator’s judgement, could benefit from treatment with collagenase
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception: a. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit b. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit c. A male sexual partner who agrees to use a male condom with spermicide d. A sterile sexual partner e. Sexual abstinence Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women of child-bearing potential, pregnancy test result must be negative at screening and Day 1 predose.
You likely can't join if
- Previous Dupuytren contracture treatments: a. surgical treatments: patients who underwent fasciectomy or surgical fasciotomy in the selected primary hand, and patients treated with needle aponeurotomy (percutaneous needle fasciotomy) in the selected joint; b. pharmacological treatments: patients previously treated with any pharmacological treatment of Dupuytren’s contracture in the selected primary hand within 90 days prior to screening. Additionally, patients previously treated with C. histolyticum in the same finger of the selected joint, or with V. alginolyticus collagenase, regardless of the hand or joint treated. However, patients enrolled in a placebo study arm in previous clinical trials of V. alginolyticus collagenase may be included
- Hand disorders: chronic muscular, neurological or neuromuscular disorders affecting hands which may interfere with the clinical assessment
- Bleeding and anticoagulants: history of bleeding, coagulopathies including any disorder that could increase the patient’s tendency to bruising or haematoma or bleeding, anticoagulant or antiaggregant therapy within 7 days of the screening with the exception of daily intake of ≤150 mg of acetylsalicylic acid
- Allergy: ascertained or presumptive hypersensitivity to collagenase; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- Diseases: significant history of cardiovascular, skin, endocrine or neurological diseases that affected the hands or of any other medical condition which may interfere with the aim of the study (including clinically significant abnormal ECG)
- Medications: intake of tetracycline derivatives within 14 days before the screening
See the full eligibility criteria
Who can join
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men/women, ≥18 year old inclusive
- Dupuytren contracture: diagnosis of Dupuytren contracture with a fixed flexion deformity ≥20° and ≤100°, if in a MP joint, or ≥20° and ≤80°, if in a PIP joint, of at least one finger, other than the thumb, caused by a palpable cord that, according to the investigator’s judgement, could benefit from treatment with collagenase
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception: a. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit b. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit c. A male sexual partner who agrees to use a male condom with spermicide d. A sterile sexual partner e. Sexual abstinence Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women of child-bearing potential, pregnancy test result must be negative at screening and Day 1 predose.
What rules you out
- Previous Dupuytren contracture treatments: a. surgical treatments: patients who underwent fasciectomy or surgical fasciotomy in the selected primary hand, and patients treated with needle aponeurotomy (percutaneous needle fasciotomy) in the selected joint; b. pharmacological treatments: patients previously treated with any pharmacological treatment of Dupuytren’s contracture in the selected primary hand within 90 days prior to screening. Additionally, patients previously treated with C. histolyticum in the same finger of the selected joint, or with V. alginolyticus collagenase, regardless of the hand or joint treated. However, patients enrolled in a placebo study arm in previous clinical trials of V. alginolyticus collagenase may be included
- Hand disorders: chronic muscular, neurological or neuromuscular disorders affecting hands which may interfere with the clinical assessment
- Bleeding and anticoagulants: history of bleeding, coagulopathies including any disorder that could increase the patient’s tendency to bruising or haematoma or bleeding, anticoagulant or antiaggregant therapy within 7 days of the screening with the exception of daily intake of ≤150 mg of acetylsalicylic acid
- Allergy: ascertained or presumptive hypersensitivity to collagenase; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- Diseases: significant history of cardiovascular, skin, endocrine or neurological diseases that affected the hands or of any other medical condition which may interfere with the aim of the study (including clinically significant abnormal ECG)
- Medications: intake of tetracycline derivatives within 14 days before the screening
- Investigative drug studies: previous participation in any clinical studies within 30 days before the screening visit
- Blood donation: blood donations for 3 months before this study
- Pregnancy (women of child-bearing potential only): positive or missing pregnancy test at screening or Day 1, pregnant or lactating women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.