Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

NCT03675685 | Completed Phase 1 Results FDA Drug

• 1 other identifier: EN3835-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP). This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.

Conditions

Edematous Fibrosclerotic Panniculopathy

Keywords

Cellulite; Edematous Fibrosclerotic Panniculopathy; EFP

Outcome Measures

Primary Outcomes (4)

• Plasma AUX-I and AUX-II Concentrations

  Determine if there is systemic exposure following a subcutaneous single dose of Collagenase clostridium histolyticum (CCH) (3.36 mg) as 12 injections per quadrant in 4 quadrants concurrently (0.84 mg per quadrant) in adult women with Edematous Fibrosclerotic Panniculopathy (EFP). There were no quantifiable levels of plasma AUX-I or AUX-II observed at any collection time point following subcutaneous injection of EN3835. As a result, no pharmacokinetic (PK) parameters were calculated.

  Day 1 to Day 22

• Investigator CR-PCSS Rating

  Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation done at the Screening visit (Baseline) and at End of Study (Day 22). CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). Negative change reflects an improvement in cellulite severity; positive change reflects a worsening in cellulite severity.

  Day 1 to Day 22

• Investigator CR-PCSS Change From Baseline

  Change from Baseline (Day 22 - Baseline). Baseline Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation done at the Screening visit. CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). Negative change reflects an improvement in cellulite severity; positive change reflects a worsening in cellulite severity.

  Day 1 to Day 22

• Investigator CR-PCSS Responder Analysis at End of Study

  Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation at the end of study. CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-point responder is a participant with a reduction of cellulite severity by at least 2 severity levels from baseline to end of study (i.e., change from baseline CR-PCSS rating of -2, -3, or -4). A 1-point responder is a participant with a reduction of cellulite severity by at least 1 severity level from baseline to end of study (i.e., change from baseline CR-PCSS rating of -1, -2, -3, or -4).

  Day 22

Study Arms (1)

CCH (Collagenase clostridium histolyticum)

EXPERIMENTAL

Biological: CCH (collagenase clostridium histolyticum)

Interventions

CCH (collagenase clostridium histolyticum) BIOLOGICAL

A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.

CCH (Collagenase clostridium histolyticum)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No subject will be dosed until all eligibility criteria have been satisfied. In order to be eligible to participate in the study, subjects must meet the following criteria:
• Be a female ≥18 years of age.
• Have evidence of cellulite within 4 quadrants (a quadrant is defined as a left buttock, right buttock, left posterolateral thigh or right posterolateral thigh) as assessed by the Investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at the Screening visit; has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 4 quadrants at the Screening visit.
• Have a body mass index (BMI) between 20.0 and 35.0 kg/m\^2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤10% from baseline body weight is permitted).
• Be willing to apply sunscreen to the dosing quadrants before each exposure to the sun while participating in the study (ie, screening through end of study).
• Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening.
• Have a negative pregnancy test at the Screening visit and on Day -1 at admission (before injection of study drug); and be using an effective contraception method (e.g., abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or double barrier control) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile (i.e., hysterectomy, bilateral oophorectomy, tubal ligation).
• Be willing and able to cooperate with the requirements of the study.
• Voluntarily sign and date an informed consent form approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).

You may not qualify if:

• A subject will be excluded from study participation if she:
• Has any of the following systemic conditions:
• Coagulation disorder
• Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
• History of keloidal scarring or abnormal wound healing
• Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor.
• Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
• Has any of the following local conditions in the areas to be treated:
• History of lower extremity thrombosis or post-thrombosis syndrome
• Vascular disorder (e.g., varicose veins) in areas to be treated
• Inflammation or active infection
• Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
• Has a tattoo located within 2 cm of the site of injection
• Requires the following concomitant medications before or during participation in the trial:
• a. Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

Endo Clinical Trial Site #1

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cellulite

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Saji Vijayan, MBBS
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

800-462-3636

Study Officials

• Saji Vijayan, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: September 18, 2018
• Study Start: September 18, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 6, 2020
• Results First Posted: October 6, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)