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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Only Group | No Intervention | ||
| Treated or Retreated Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EN3835 | Biological | Treatment or retreatment with EN3835 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants reporting adverse events (AE) | Proportion of participants reporting AE during the study assessed by incidence, severity and duration | Day 1 to Day 450 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Green | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #12 | Bakersfield | California | 19331 | United States | ||
| Endo Clinical Trial Site #3 |
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| Observational Days 60, 120, 180, 270, 360, and 450 |
| Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study | 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. | Observational Days 60, 120, 180, 270, 360, and 450 |
| Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study | Change from baseline in the nodular hardness of the treated nodules measured by durometer | Observational Days 60, 120, 180, 270, 360, and 450 |
| 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 | Change from baseline in the nodular consistency of the treated nodules by palpation | Observational Days 60, 120, 180, 270, 360, and 450 |
| Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study | Change from baseline on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable) | Observational Days 60, 120, 180, 270, 360, and 450 |
| Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study | Proportion of participants that meet Treatment Session 1 criteria | Days 180 or 270 |
| Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study | Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale | Observational Days 60, 120, 180, 270, 360, and 450 |
| Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study | Proportion of participants reporting "Minimally Improved" (+1), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale | Observational Days 60, 120, 180, 270, 360, and 450 |
| Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study | 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) to Retreatment Days 15, 29,43, 57, 117, 197, and 237 |
| 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 | 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) to Retreatment Days 15, 29,43, 57, 117, 197, and 237 |
| Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study | 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) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237 |
| 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 | Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study | Change from baseline (Retreatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable) | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study | Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days | Retreatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study | 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 | Retreatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study | 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 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study | 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 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study | 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) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study | Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation | Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study | Change from baseline (Treatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable) | Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study | Proportion of participants reporting to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale | Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study | Proportion of participants reporting "Minimally Improved" (+1 ), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale | Treatment Days 15, 29, 43, 57, 117, 197, and 237 |
| Presence of anti-AUX-I and anti-AUX-II antibody titer levels | Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated and retreated participants | Retreatment/Treatment Day 57 and Day 450 |
| Presence of neutralizing antibodies to AUX-I and AUX-II | Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated and retreated participants | Retreatment/ Treatment Day 57 and Day 450 |
| Fresno |
| California |
| 93710 |
| United States |
| Endo Clinical Trial Site #23 | La Mesa | California | 91942 | United States |
| Endo Clinical Trial Site #13 | Tarzana | California | 91356 | United States |
| Endo Clinical Trial Site #15 | Vista | California | 92083 | United States |
| Endo Clinical Trial Site #18 | Whittier | California | 90603 | United States |
| Endo Clinical Trial Site #24 | Miami | Florida | 33176 | United States |
| Endo Clinical Trial Site #8 | Pinellas Park | Florida | 33782 | United States |
| Endo Clinical Trial Site #21 | Sweetwater | Florida | 33172 | United States |
| Endo Clinical Trial Site #22 | Lawrenceville | Georgia | 30043 | United States |
| Endo Clinical Trial Site #25 | Meridian | Idaho | 83642 | United States |
| Endo Clinical Trial Site #19 | Decatur | Illinois | 62521 | United States |
| Endo Clinical Trial Site #2 | O'Fallon | Illinois | 62269 | United States |
| Endo Clinical Trial Site #14 | Springfield | Illinois | 62704 | United States |
| Endo Clinical Trial Site #6 | Pasadena | Maryland | 21122 | United States |
| Endo Clinical Trial Site #16 | Jefferson City | Missouri | 65109 | United States |
| Endo Clinical Trial Site #9 | York | Pennsylvania | 17402 | United States |
| Endo Clinical Trial Site #4 | Bedford | Texas | 76021 | United States |
| Endo Clinical Trial Site #17 | Dallas | Texas | 75208 | United States |
| Endo Clinical Trial Site #26 | Dallas | Texas | 75251 | United States |
| Endo Clinical Trial Site #5 | Fort Worth | Texas | 76104 | United States |
| Endo Clinical Trial Site #27 | Georgetown | Texas | 78628 | United States |
| Endo Clinical Trial Site #7 | Houston | Texas | 77027 | United States |
| Endo Clinical Trial Site #10 | Houston | Texas | 77095 | United States |
| Endo Clinical Trial Site #1 | McAllen | Texas | 78501 | United States |
| Endo Clinical Trial Site #11 | Salt Lake City | Utah | 84107 | United States |
| Endo Clinical Trial Site #20 | Suffolk | Virginia | 23434 | United States |
| ID | Term |
|---|---|
| D000071380 | Fibromatosis, Plantar |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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