Clinical trial NCT05152173: Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
Official title: Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plantar Fibromatosis
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 177
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: This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.


Eligibility criteria: Inclusion Criteria:

1. Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination.
2. Has no significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration.
3. Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening 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. 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 Screening Visit); or, if of childbearing potential, be non-pregnant, 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.
6. Willing and able to comply with all protocol required visits and assessments.
7. Be adequately informed and understand the nature and risks of the study and be able to provide consent.

Exclusion Criteria:

1. Has the presence of non-plantar fibromatosis-related nodules on the foot/feet (eg, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
2. Has any musculoskeletal, neuromuscular, neurosensory, 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.
3. Has a known allergy to collagenase or any other excipient of EN3835.
4. 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.
5. Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor.
6. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
7. Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for the study.

Primary outcomes:
measure: Mean Change between EN3835 and placebo in the Foot Function Index (FFI) pain subscale
timeFrame: Baseline (Day1) to Day 57
Secondary outcomes:
measure: Mean Change with EN3835 and placebo in the FFI pain subscale
timeFrame: Mean Change from Baseline (Day 1) to Days 15, 29, 43, and 57
measure: Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined)
timeFrame: Baseline (Day 1) to Day 57
measure: Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined)
timeFrame: Mean change from Baseline (Day 1) to Days15, 29, 43, and 57
measure: Change in the proportion of EN3835-treated participants and those receiving only placebo reporting a 7-point scale Clinician Global Impression of Change Scale
timeFrame: Days 15, 29, 43, and 57
measure: Mean change between EN3835 and placebo in the nodular hardness of the treated nodules by durometer measurement
timeFrame: Baseline (Day 1) to Day 57
measure: Mean change from Baseline in the nodular hardness of the treated nodules by durometer measurements with EN3835 vs placebo
timeFrame: Baseline (Day 1) to Days 15, 29, 43, 57
measure: Safety of EN3835 as assessed by incidence, severity, and duration of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
timeFrame: Up to Day 57
measure: Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated participants
timeFrame: Day 1 and Day 57
measure: Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated-participants
timeFrame: Day 1 and Day 57
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Endo Clinical Trial Site #29
state: Arizona
city: Tucson
country: United States
facility: Endo Clinical Trial Site #42
state: Arizona
city: Bakersfield
country: United States
facility: Endo Clinical Trial Site #15
state: California
city: Encinitas
country: United States
facility: Endo Clinical Trial Site #41
state: California
city: Fresno
country: United States
facility: Endo Clinical Trial Site #9
state: California
city: La Mesa
country: United States
facility: Endo Clinical Trial Site #27
state: California
city: Los Angeles
country: United States
facility: Endo Clinical Trial Site #30
state: California
city: Tarzana
country: United States
facility: Endo Clinical Trial Site #12
state: California
city: Torrance
country: United States
facility: Endo Clinical Trial Site #36
state: California
city: Vista
country: United States
facility: Endo Clinical Trial Site #22
state: California
city: Whittier
country: United States
facility: Endo Clinical Trial Site #13
state: California
city: Atlantis
country: United States
facility: Endo Clinical Trial Site #16
state: Florida
city: Jacksonville
country: United States
facility: Endo Clinical Trial Site #43
state: Florida
city: Miami
country: United States
facility: Endo Clinical Trial Site #40
state: Florida
city: Pinellas Park
country: United States
facility: Endo Clinical Trial Site #10
state: Florida
city: South Miami
country: United States
facility: Endo Clinical Trial Site #3
state: Florida
city: Sweetwater
country: United States
facility: Endo Clinical Trial Site #14
state: Florida
city: Lawrenceville
country: United States
facility: Endo Clinical Trial Site #38
state: Georgia
city: Meridian
country: United States
facility: Endo Clinical Trial Site #31
state: Idaho
city: Decatur
country: United States
facility: Endo Clinical Trial Site #32
state: Illinois
city: O'Fallon
country: United States
facility: Endo Clinical Trial Site #19
state: Illinois
city: Springfield
country: United States
facility: Endo Clinical Trial Site #33
state: Illinois
city: Pasadena
country: United States
facility: Endo Clinical Trial Site #23
state: Maryland
city: Jefferson City
country: United States
facility: Endo Clinical Trial Site #28
state: Missouri
city: Las Vegas
country: United States
facility: Endo Clinical Trial Site #20
state: Nevada
city: Oklahoma City
country: United States
facility: Endo Clinical Trial Site #34
state: Oklahoma
city: York
country: United States
facility: Endo Clinical Trial Site #4
state: Pennsylvania
city: Arlington
country: United States
facility: Endo Clinical Trial Site #35
state: Texas
city: Bedford
country: United States
facility: Endo Clinical Trial Site #5
state: Texas
city: Cedar Park
country: United States
facility: Endo Clinical Trial Site #24
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 #2
state: Texas
city: Fort Worth
country: United States
facility: Endo Clinical Trial Site #7
state: Texas
city: Georgetown
country: United States
facility: Endo Clinical Trial Site #39
state: Texas
city: Houston
country: United States
facility: Endo Clinical Trial Site #25
state: Texas
city: Houston
country: United States
facility: Endo Clinical Trial Site #8
state: Texas
city: McAllen
country: United States
facility: Endo Clinical Trial Site #1
state: Texas
city: San Antonio
country: United States
facility: Endo Clinical Trial Site #21
state: Texas
city: San Antonio
country: United States
facility: Endo Clinical Trial Site #6
state: Texas
city: Salt Lake City
country: United States
facility: Endo Clinical Trial Site #18
state: Utah
city: Lynchburg
country: United States
facility: Endo Clinical Trial Site #26
state: Virginia
city: Midlothian
country: United States
facility: Endo Clinical Trial Site #37
state: Virginia
city: Suffolk
country: United States
facility: Endo Clinical Trial Site #11
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Nina Green
role: STUDY_DIRECTOR
References: