Neoplasms

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Rare Diseases

Fibromatosis, Plantar

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Foot Diseases

Contracture

Muscular Diseases

Connective Tissue Diseases

Skin Diseases

Ledderhose Disease

Treatment or retreatment with up to two doses of EN3835

EN3835

Nina Green

Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 and assess the efficacy and safety of EN3835 in the treatment and retreatment of Plantar Fibromatosis.

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

Proportion of participants reporting AE during the study assessed by incidence, severity and duration

Change from baseline on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.

Change from baseline on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.

Change from baseline in the nodular hardness of the treated nodules measured by durometer

Change from baseline in the nodular consistency of the treated nodules by palpation

Change from baseline on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)

Proportion of participants that meet Treatment Session 1 criteria

Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

Proportion of participants reporting "Minimally Improved" (+1), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale

Change from baseline (Retreatment Day 1) with EN3835 on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.

Change from baseline (Retreatment Day 1) with EN3835 on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.

Change from baseline (Retreatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer

Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation

Change from baseline (Retreatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)

Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days

Proportion of participants reporting "Minimally Improved" (+1), "Much Improved (+2)" or "Very Much Improved (+3) on the Clinician Global Impression of Change Scale on Retreatment Days

Change from baseline (Treatment Day 1) with EN3835 on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.

Change from baseline (Treatment Day 1) with EN3835 on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.

Change from baseline (Treatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer

Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation

Change from baseline (Treatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)

Proportion of participants reporting to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

Proportion of participants reporting "Minimally Improved" (+1 ), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale

Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated and retreated participants

Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated and retreated participants

Endo Pharmaceuticals

Placebo

Clinical Operations

Luis Ortega

This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).

Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)

Participant will receive a maximum dose of up to 1.8mg of EN3835 injection

Participant will receive a maximum dose of up to 1.8mg of Placebo injection

Participant will receive a maximum dose of up to1.8mg of EN3835 injection

Participant will receive a maximum dose of up to1.8mg of Placebo injection

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.

Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis

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

Mean change on the foot pain subscale (total score on 9 items) of the FFI ranging from 0 ("None") to 4 ("Extreme").

Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined)

Change in the proportion of EN3835-treated participants and those receiving only placebo reporting a 7-point scale Clinician Global Impression of Change Scale ranging from -3 ("Very Much Worse") to +3 ("Very Much Improvement")

Mean change between EN3835 and placebo in the nodular hardness of the treated nodules by durometer measurement

Mean change from Baseline in the nodular hardness of the treated nodules by durometer measurements with EN3835 vs placebo

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)

Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated participants

Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated-participants

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis	NCT05254457	Plantar Fibroma...	EN3835	18 Years -	Endo Pharmaceuticals
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)	NCT06151197	Plantar Fibroma... Ledderhose Dise...	EN3835 Placebo	18 Years -	Endo Pharmaceuticals
Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis	NCT05152173	Plantar Fibroma...	EN3835 Placebo	18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for plantar fibromatosis