A Phase 3 interventional study of CCH-aaes and Observation in Edematous Fibrosclerotic Panniculopathy and Cellulite, sponsored by Endo Pharmaceuticals. Completed at 42 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 3, Interventional, and Treatment
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum [CCH]-aaes) lasts in the treatment of Cellulite.
This study included participants who completed EN3835-302 (NCT03428750) or EN3835-303 (NCT03446781) double-blind parent studies. The first part of this study consisted of an observational period conducted in a blinded fashion and where no treatments were administered between Day 71 of the parent studies and Day 180 in this Open-label extension study. Once these participants were unblinded at Day 180, only participants who received active CCH-aaes in the parent studies remained in this study and those who received placebo in the parent studies were not eligible to continue in the Open-label study. Assessments made at the Day 71/(End of Study [EOS]) visit of the parent studies served as initial screening assessments for this study.
In the Open-label Phase of the study, all participants who qualified for, and opted for, retreatment were administered CCH-aaes at 3 treatment sessions at 21-day intervals.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 483 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
All Participants (Through Day 180):
Key Inclusion Criteria for Participants Eligible for Retreatment:
Key Exclusion Criteria
All Participants (Through Day 180):
Additional Exclusion Criteria may apply Post Day 180:
Key Exclusion Criteria for Participants Eligible for Retreatment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
Biological: CCH-aaes · Other: Observation
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued. No treatment was administered.
Other: Observation
Administered to participants who qualified for, and opted for, retreatment.
Also known as: EN3835, QWO™
No treatment administered during 180 days of observation.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to Day 1080
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
Time frame: From Day 180 (Open-label Phase) up to Day 1080
Time to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in PR-PCSS and CR-PCSS to the time at which a 2-level composite worsening of response was observed for the first time.
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which 1-level composite worsening of response was observed for the first time.
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to Complete Loss of Response in CR-PCSS and PR-PCSS
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Complete loss of response is defined as both CR-PCSS and PR-PCSS ratings returned to the baseline severity of the double-blind study or worse for both the buttocks. Time to complete loss of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which complete loss of response was observed for the first time.
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
| Milestone | CCH-aaes Treatment in Parent Studies EN3835-302/303 | Placebo Treatment in Parent Studies EN3835-302/303 |
|---|---|---|
| Started | 243 | 240 |
| Completed day 180 | 243 | 240 |
| Completed | 202 | 0 |
| Not completed | 41 | 240 |
| Withdrew: Participants who received placebo in parent studies were discontinued | 0 | 238 |
| Withdrew: Withdrawal by subject | 40 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | CCH-aaes Treatment in Parent Studies EN3835-302/303 | Placebo Treatment in Parent Studies EN3835-302/303 |
|---|---|---|
| Started | 202 | 0 |
| Cch-aaes retreatment | 55 | 0 |
| Completed | 104 | 0 |
| Not completed | 98 | 0 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 54 | 0 |
| Withdrew: Lost to follow-up | 35 | 0 |
| Withdrew: Other than specified | 5 | 0 |
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
| Participants | Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303 | Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303 | Open-label Phase (Prior to Retreatment) | Open-label CCH-aaes Retreatment Phase |
|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 58 | 29 | 43 | 45 |
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
| percentage of participants | Open-label Phase (Prior to Retreatment) | Open-label CCH-aaes Retreatment Phase |
|---|---|---|
| Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment | 98.2 | 100 |
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in PR-PCSS and CR-PCSS to the time at which a 2-level composite worsening of response was observed for the first time.
| days | Open-label Phase (Prior to Retreatment) |
|---|---|
| Time to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) | NA |
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which 1-level composite worsening of response was observed for the first time.
| days | Open-label Phase (Prior to Retreatment) |
|---|---|
| Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS | 356.5 ± 232.43 |
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Complete loss of response is defined as both CR-PCSS and PR-PCSS ratings returned to the baseline severity of the double-blind study or worse for both the buttocks. Time to complete loss of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which complete loss of response was observed for the first time.
| days | Open-label Phase (Prior to Retreatment) |
|---|---|
| Time to Complete Loss of Response in CR-PCSS and PR-PCSS | 238.2 ± 85.75 |
Collected over Up to Day 1080. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303 | 0/243 (0%) | 1/243 (0.4%) | 27/243 (11.1%) |
| Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303 | 0/240 (0%) | 1/240 (0.4%) | 0/240 (0%) |
| Open-label Phase (Prior to Retreatment) | 0/202 (0%) | 3/202 (1.5%) | 7/202 (3.5%) |
| Open-label CCH-aaes Retreatment Phase | 0/55 (0%) | 3/55 (5.5%) | 31/55 (56.4%) |
| Event | Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303 | Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303 | Open-label Phase (Prior to Retreatment) | Open-label CCH-aaes Retreatment Phase |
|---|---|---|---|---|
| Corona virus infectionInfections and infestations | 0/243 | 0/240 | 0/202 | 1/55 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 0/243 | 0/240 | 0/202 | 1/55 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/243 | 0/240 | 0/202 | 1/55 |
| Premature separation of placentaPregnancy, puerperium and perinatal conditions | 0/243 | 0/240 | 0/202 | 1/55 |
| Diffuse large B-cell lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/243 | 0/240 | 1/202 | 0/55 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/243 | 0/240 | 1/202 | 0/55 |
| Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/243 | 0/240 | 1/202 | 0/55 |
| Cholecystitis acuteHepatobiliary disorders | 0/243 | 0/240 | 1/202 | 0/55 |
| Hip fractureInjury, poisoning and procedural complications | 0/243 | 1/240 | 0/202 | 0/55 |
| Meningitis viralInfections and infestations | 1/243 | 0/240 | 0/202 | 0/55 |
| Event | Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303 | Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303 | Open-label Phase (Prior to Retreatment) | Open-label CCH-aaes Retreatment Phase |
|---|---|---|---|---|
| Injection site bruisingGeneral disorders | 12/243 | 0/240 | 0/202 | 31/55 |
| Injection site painGeneral disorders | 0/243 | 0/240 | 0/202 | 10/55 |
| Injection site pruritusGeneral disorders | 0/243 | 0/240 | 0/202 | 9/55 |
| Injection site erythemaGeneral disorders | 0/243 | 0/240 | 0/202 | 6/55 |
| Injection site discolourationGeneral disorders | 10/243 | 0/240 | 2/202 | 4/55 |
| Injection site noduleGeneral disorders | 3/243 | 0/240 | 0/202 | 4/55 |
| Injection site swellingGeneral disorders | 1/243 | 0/240 | 0/202 | 4/55 |
| Corona virus infectionInfections and infestations | 0/243 | 0/240 | 5/202 | 3/55 |
| Injection site haemorrhageGeneral disorders | 1/243 | 0/240 | 0/202 | 3/55 |
| Injection site indurationGeneral disorders | 0/243 | 0/240 | 0/202 | 3/55 |
Day 180 Observation Phase Population: All rollover participants who completed the parent studies (EN3835-302 or EN3835-303) (CCH-aaes-treated or placebo-treated).
| Age, Continuous(years) | Overall Participants |
|---|---|
| Mean | 47.6 ± 10.73 |
| Sex: Female, Male(Participants) | Overall Participants |
|---|---|
| Female | 483 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Overall Participants |
|---|---|
| Race : American Indian or Alaska Native | 2 |
| Race : Asian | 3 |
| Race : Black or African American | 87 |
| Race : Native Hawaiian or Other Pacific Islander | 1 |
| Race : White | 382 |
| Race : Other | 2 |
| Race : Multiple | 6 |
| Ethnicity: Hispanic or Latino | 90 |
| Ethnicity: Not Hispanic or Latino | 393 |
| Body Mass Index (BMI)(kg/m^2) | Overall Participants |
|---|---|
| Mean | 31.00 ± 7.108 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Oct 2021, 41 months.
Results were first posted in Sep 2023, 1 year 11 months after primary completion.
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Studies of the drug tested here: Microbial Collagenase