Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EN3835 Group | Experimental | Participant will receive a maximum dose of up to 1.8mg of EN3835 injection |
|
| Placebo Group | Placebo Comparator | Participant will receive a matched Placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EN3835 | Biological | Participant will receive a maximum dose of up to1.8mg of EN3835 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score | FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment. | Baseline (Day 1), Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score | The FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. The FFI difficulty subscale consisted of 9 items which were scored on a scale of 0 ("No difficulty") to 4 ("A lot of difficulty") with a total score ranging from 0 to 36. The Total Combined score of pain and difficulty comprised scores of answered items in each subscale with a maximum total score range of 0 to 72. Lower scores indicated better foot function, while higher scores reflected greater impairment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luis Ortega, MD | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #29 | Mesa | Arizona | 85206 | United States | ||
| Endo Clinical Trial Site #42 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EN3835 Group | Participants received a maximum dose of up to 1.8 milligrams (mg) EN3835 intralesional injection on Day 1. |
| FG001 | Placebo Group | Participants received a placebo matched to EN3835 intralesional injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2022 | Dec 19, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Participant will receive a matched Placebo injection |
|
| Baseline (Day 1), Day 57 |
| Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale | The responder (by foot/feet) was defined as a participant with a response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" in the CGIC Scale. All participants who withdrew early from the study were considered as non-responders. If participant was treated for both feet, then the assessment could be combined at participant level using worst case approach, if one foot response was recorded as 'Minimal Improvement' and 'Very Much Improvement' in another foot, then response was considered as 'Minimal Improvement'. | Day 57 |
| Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement | A durometer was used to measure the hardness of treated nodules, on a scale ranging from 0 to 100. Higher scores indicated a greater hardness. | Baseline (Day 1), Day 57 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Endo Clinical Trial Site #15 | Bakersfield | California | 93311 | United States |
| Endo Clinical Trial Site #41 | Encinitas | California | 92024 | United States |
| Endo Clinical Trial Site #9 | Fresno | California | 93710 | United States |
| Endo Clinical Trial Site #27 | La Mesa | California | 91942 | United States |
| Endo Clinical Trial Site #30 | Los Angeles | California | 90010 | United States |
| Endo Clinical Trial Site #12 | Tarzana | California | 91356 | United States |
| Endo Clinical Trial Site #36 | Torrance | California | 90502 | United States |
| Endo Clinical Trial Site #22 | Vista | California | 92083 | United States |
| Endo Clinical Trial Site #13 | Whittier | California | 90603 | United States |
| Endo Clinical Trial Site #16 | Atlantis | Florida | 33462 | United States |
| Endo Clinical Trial Site #43 | Jacksonville | Florida | 32209 | United States |
| Endo Clinical Trial Site #40 | Miami | Florida | 33176 | United States |
| Endo Clinical Trial Site #10 | Pinellas Park | Florida | 33782 | United States |
| Endo Clinical Trial Site #3 | South Miami | Florida | 33143 | United States |
| Endo Clinical Trial Site #14 | Sweetwater | Florida | 33172 | United States |
| Endo Clinical Trial Site #38 | Lawrenceville | Georgia | 30043 | United States |
| Endo Clinical Trial Site #31 | Meridian | Idaho | 83642 | United States |
| Endo Clinical Trial Site #32 | Decatur | Illinois | 62521 | United States |
| Endo Clinical Trial Site #19 | O'Fallon | Illinois | 62269 | United States |
| Endo Clinical Trial Site #33 | Springfield | Illinois | 62704 | United States |
| Endo Clinical Trial Site #23 | Pasadena | Maryland | 21122 | United States |
| Endo Clinical Trial Site #28 | Jefferson City | Missouri | 65109 | United States |
| Endo Clinical Trial Site #20 | Las Vegas | Nevada | 89119 | United States |
| Endo Clinical Trial Site #34 | Oklahoma City | Oklahoma | 73109 | United States |
| Endo Clinical Trial Site #4 | York | Pennsylvania | 17402 | United States |
| Endo Clinical Trial Site #35 | Arlington | Texas | 76015 | United States |
| Endo Clinical Trial Site #5 | Bedford | Texas | 76021 | United States |
| Endo Clinical Trial Site #24 | Cedar Park | Texas | 78613 | United States |
| Endo Clinical Trial Site #17 | Dallas | Texas | 75208 | United States |
| Endo Clinical Trial Site #2 | Dallas | Texas | 75251 | United States |
| Endo Clinical Trial Site #7 | Fort Worth | Texas | 76104 | United States |
| Endo Clinical Trial Site #39 | Georgetown | Texas | 78628 | United States |
| Endo Clinical Trial Site #25 | Houston | Texas | 77027 | United States |
| Endo Clinical Trial Site #8 | Houston | Texas | 77095 | United States |
| Endo Clinical Trial Site #1 | McAllen | Texas | 78501 | United States |
| Endo Clinical Trial Site #21 | San Antonio | Texas | 78211 | United States |
| Endo Clinical Trial Site #6 | San Antonio | Texas | 78229 | United States |
| Endo Clinical Trial Site #18 | Salt Lake City | Utah | 84107 | United States |
| Endo Clinical Trial Site #26 | Lynchburg | Virginia | 24501 | United States |
| Endo Clinical Trial Site #37 | Midlothian | Virginia | 23114 | United States |
| Endo Clinical Trial Site #11 | Suffolk | Virginia | 23434 | United States |
| Intent to Treat Set |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent to treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EN3835 Group | Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1. |
| BG001 | Placebo Group | Participants received a placebo matched to EN3835 intralesional injection on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Foot Function Index (FFI) Total Pain Subscale Score | FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment. | Here, number analyzed signifies those participants who were evaluable for this parameter. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score | FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment. | The ITT Population included all randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1), Day 57 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score | The FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. The FFI difficulty subscale consisted of 9 items which were scored on a scale of 0 ("No difficulty") to 4 ("A lot of difficulty") with a total score ranging from 0 to 36. The Total Combined score of pain and difficulty comprised scores of answered items in each subscale with a maximum total score range of 0 to 72. Lower scores indicated better foot function, while higher scores reflected greater impairment. | The ITT Population included all randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1), Day 57 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale | The responder (by foot/feet) was defined as a participant with a response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" in the CGIC Scale. All participants who withdrew early from the study were considered as non-responders. If participant was treated for both feet, then the assessment could be combined at participant level using worst case approach, if one foot response was recorded as 'Minimal Improvement' and 'Very Much Improvement' in another foot, then response was considered as 'Minimal Improvement'. | The ITT Population included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 57 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement | A durometer was used to measure the hardness of treated nodules, on a scale ranging from 0 to 100. Higher scores indicated a greater hardness. | The ITT Population included all randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1), Day 57 |
|
|
Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EN3835 Group | Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1. | 0 | 88 | 0 | 87 | 58 | 87 |
| EG001 | Placebo Group | Participants received a placebo matched to EN3835 intralesional injection on Day 1. | 0 | 88 | 2 | 87 | 35 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site pruritis | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site exfoliation | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fascial rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Plantar fascial fibromatosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Precancerous cells present | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Endo Pharmaceuticals | 800-462-3636 | clinicaltrials@endo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2023 | Dec 18, 2025 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
|
|
|
|
| Participants |
|
|
|
|
|