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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06151197




Registration number
NCT06151197
Ethics application status
Date submitted
21/11/2023
Date registered
30/11/2023
Date last updated
1/11/2024

Titles & IDs
Public title
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
Scientific title
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)
Secondary ID [1] 0 0
EN3835-309
Universal Trial Number (UTN)
Trial acronym
STRIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar Fibromatosis 0 0
Ledderhose Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - EN3835
Other interventions - Placebo

Experimental: EN3835 -

Placebo comparator: Placebo -


Treatment: Other: EN3835
Biologic: EN3835 injection

Other interventions: Placebo
Placebo injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score
Timepoint [1] 0 0
Baseline, up to Day 85
Secondary outcome [2] 0 0
Change from Baseline in the FFI Activity Limitation Subscale Score
Timepoint [2] 0 0
Baseline, up to Day 85
Secondary outcome [3] 0 0
Change from Baseline in the FFI Pain Subscale Score
Timepoint [3] 0 0
Baseline, up to Day 85
Secondary outcome [4] 0 0
Change from Baseline in the FFI Total Score
Timepoint [4] 0 0
Baseline, up to Day 85
Secondary outcome [5] 0 0
Number of Participants That Used Rescue Analgesic Medication
Timepoint [5] 0 0
Up to Day 85
Secondary outcome [6] 0 0
Amount of (milligrams [mg]) Rescue Analgesic Medication Used
Timepoint [6] 0 0
Up to Day 85
Secondary outcome [7] 0 0
Patient Global Impression of Change (PGIC) Foot Pain Score
Timepoint [7] 0 0
Up to Day 85
Secondary outcome [8] 0 0
Clinician Global Impression of Change (CGIC) Score
Timepoint [8] 0 0
Up to Day 85
Secondary outcome [9] 0 0
Subject Satisfaction Score
Timepoint [9] 0 0
Up to Day 85
Secondary outcome [10] 0 0
Change from Baseline in Nodule Consistency (Firmness)
Timepoint [10] 0 0
Baseline, up to Day 85
Secondary outcome [11] 0 0
Change from Baseline in the Nodular Hardness of the Treated Nodules
Timepoint [11] 0 0
Up to Day 85

Eligibility
Key inclusion criteria
Key

* Be an ambulatory male or female =18 years of age.
* Have a diagnosis of PFI.
* Have current foot pain due to PFI.
* Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
* 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.
* Be capable of providing consent, are adequately informed, and understand the nature and risks of the study.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
* Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
* Has any 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 or required assessments and evaluations.
* Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
* Has a clinically significant laboratory abnormality.
* 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, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor.
* Has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
* Is pregnant or plans to become pregnant.
* Is breastfeeding or is providing or plans to provide breast milk in any manner during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
418
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Endo Site 58 - East Maitland
Recruitment hospital [2] 0 0
Endo Site 57 - Hunter
Recruitment postcode(s) [1] 0 0
2320 - East Maitland
Recruitment postcode(s) [2] 0 0
2290 - Hunter
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endo Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
Trial website
https://clinicaltrials.gov/study/NCT06151197
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luis Ortega
Address 0 0
Endo Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
800-462-3636
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06151197