Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CCH · 1 trial · 1 indication
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.
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.
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.
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).
| Arm | Type | Description |
|---|---|---|
| CCH (Collagenase clostridium histolyticum) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * 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: 1. Be a female ≥18 years of age. 2. Have evidence of cellulite within 4 quadrants (a quadrant is de...
CCH is a monoclonal antibody being developed by BrainsWay Ltd. for the treatment of Edematous Fibrosclerotic Panniculopathy (EFP). It is currently in Phase 1 clinical development as an investigational therapy.
CCH is being developed by BrainsWay Ltd., a company listed on the stock exchange under the ticker BWAY. The drug is in Phase 1 clinical development for Edematous Fibrosclerotic Panniculopathy.
CCH is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the safety and pharmacokinetics of a single dose of CCH in subjects with Edematous Fibrosclerotic Panniculopathy.
CCH has one completed Phase 1 clinical trial, identified as NCT03675685. This trial evaluated the safety and pharmacokinetics of a single 3.36 mg dose of CCH in 12 female subjects with Edematous Fibrosclerotic Panniculopathy in the United States.
Yes, CCH is a monoclonal antibody. It is being studied as a potential treatment for Edematous Fibrosclerotic Panniculopathy, a condition that affects subcutaneous tissue.