Clinical trial · Interventional
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
A Multi-Center, Open-Label, Extension Study to Evaluate the Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
NCT05254457CI-TRIAL-00087533completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of plantar fibromatosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plantar Fibromatosis | Plantar Fibromatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EN3835 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Observation Only Group
- type
- EXPERIMENTAL
- label
- Treated or Retreated Group
- interventionNames
- Biological: EN3835
Primary outcomes (1)
- measure
- Proportion of participants reporting adverse events (AE)
- timeFrame
- Day 1 to Day 450
- description
- Proportion of participants reporting AE during the study assessed by incidence, severity and duration
Secondary outcomes (24)
- measure
- Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention). 2. Willing and able to comply with all protocol required visits and assessments. 3. Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit. 4. Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period. 5. Willing and able to comply with all protocol required visits and assessments. 6. Be adequately informed and understand the nature and risks of the study and be able to provide consent 7. If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Day 1 Visit), or, if of childbearing potential, be nonpregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period. 8. Have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration. Exclusion Criteria: 1. Has any musculoskeletal, neuromuscular, neurosensory, or other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator. 2. Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study. 3. Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated. 4. Has a known systemic allergy to collagenase or any other excipient of EN3835. 5. Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study. 6. Has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration. 7. Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \<150mg of aspirin daily, 7 days prior to first injection and for the duration of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.