Clinical trial NCT05254457: Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plantar Fibromatosis
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants reporting adverse events (AE)
timeFrame: Day 1 to Day 450
Secondary outcomes:
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
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Change from baseline in the nodular consistency of the treated nodules by palpation in participants treated in the parent studies, and participants retreated in this study
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study
timeFrame: Days 180 or 270
measure: Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
timeFrame: Observational Days 60, 120, 180, 270, 360, and 450
measure: Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237
measure: Change from baseline (Retreatment) on the Foot Function Index (FFI) subscales (pain, difficulty, and activity limitation) in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237
measure: Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Retreatment Day 1) in the nodular consistency of the treated nodules by palpation in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
timeFrame: Retreatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
timeFrame: Retreatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study
timeFrame: Change from Baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
timeFrame: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
timeFrame: Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
timeFrame: Treatment Days 15, 29, 43, 57, 117, 197, and 237
measure: Presence of anti-AUX-I and anti-AUX-II antibody titer levels
timeFrame: Retreatment/Treatment Day 57 and Day 450
measure: Presence of neutralizing antibodies to AUX-I and AUX-II
timeFrame: Retreatment/ Treatment Day 57 and Day 450
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Endo Clinical Trial Site #12
state: California
city: Fresno
country: United States
facility: Endo Clinical Trial Site #3
state: California
city: La Mesa
country: United States
facility: Endo Clinical Trial Site #23
state: California
city: Tarzana
country: United States
facility: Endo Clinical Trial Site #13
state: California
city: Vista
country: United States
facility: Endo Clinical Trial Site #15
state: California
city: Whittier
country: United States
facility: Endo Clinical Trial Site #18
state: California
city: Miami
country: United States
facility: Endo Clinical Trial Site #24
state: Florida
city: Pinellas Park
country: United States
facility: Endo Clinical Trial Site #8
state: Florida
city: Sweetwater
country: United States
facility: Endo Clinical Trial Site #21
state: Florida
city: Lawrenceville
country: United States
facility: Endo Clinical Trial Site #22
state: Georgia
city: Meridian
country: United States
facility: Endo Clinical Trial Site #25
state: Idaho
city: Decatur
country: United States
facility: Endo Clinical Trial Site #19
state: Illinois
city: O'Fallon
country: United States
facility: Endo Clinical Trial Site #2
state: Illinois
city: Springfield
country: United States
facility: Endo Clinical Trial Site #14
state: Illinois
city: Pasadena
country: United States
facility: Endo Clinical Trial Site #6
state: Maryland
city: Jefferson City
country: United States
facility: Endo Clinical Trial Site #16
state: Missouri
city: York
country: United States
facility: Endo Clinical Trial Site #9
state: Pennsylvania
city: Bedford
country: United States
facility: Endo Clinical Trial Site #4
state: Texas
city: Dallas
country: United States
facility: Endo Clinical Trial Site #17
state: Texas
city: Dallas
country: United States
facility: Endo Clinical Trial Site #26
state: Texas
city: Fort Worth
country: United States
facility: Endo Clinical Trial Site #5
state: Texas
city: Georgetown
country: United States
facility: Endo Clinical Trial Site #27
state: Texas
city: Houston
country: United States
facility: Endo Clinical Trial Site #7
state: Texas
city: Houston
country: United States
facility: Endo Clinical Trial Site #10
state: Texas
city: McAllen
country: United States
facility: Endo Clinical Trial Site #1
state: Texas
city: Salt Lake City
country: United States
facility: Endo Clinical Trial Site #11
state: Utah
city: Suffolk
country: United States
facility: Endo Clinical Trial Site #20
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Nina Green
role: STUDY_DIRECTOR
References: