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To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: CCH Single Injection Technique | Experimental | Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. |
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| Group 2: CCH Single Injection Technique | Experimental | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. |
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| Group 3: CCH Single Injection Technique | Experimental | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. |
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| Group 4: CCH Multiple Injection Technique | Experimental | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum Single Injection Technique | Drug | CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported. | Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection | Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in a tissue specimen injected with 2 CCH dose injections (Treatment Area 1) relative to 1 CCH dose injection (Treatment Area 2) is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Chajko | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #1 | Montclair | New Jersey | 07042 | United States | ||
| Endo Clinical Trial Site #2 |
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Participants were divided among 6 different cohorts based on injection technique and respective dosing days. Two participants (Group 4 multiple injection technique) were not included in the Evaluable Population when their surgeries were delayed due to the effects of COVID-19 restrictions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Collagenase Clostridium Histolyticum (CCH) Single Injection Technique | Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique. Each participant had 2 marked areas of the abdomen (Area 1 and Area 2) selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. |
| FG001 | Group 2: CCH Single Injection Technique | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. |
| FG002 | Group 3: CCH Single Injection Technique | Participants were administered 0.07 mg CCH using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. |
| FG003 | Group 4: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. |
| FG004 | Group 5: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. |
| FG005 | Group 6: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Population: All participants who received at least 1 injection of study drug irrespective of the timing window of abdominoplasty. Baseline characteristics (demographic) data were combined for all participants to protect personally identifiable information (PII) of the participant and to reduce risk of participant identification in the small population size of the 2 arms/groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | CCH Subcutaneous Injection | Participants were administered 0.07 mg CCH using a single injection technique or 0.0653 mg CCH using a multiple injection technique. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported. | Evaluable Population: All participants who received at least 1 injection of study drug, underwent abdominoplasty within the protocol specified timelines, and had a histopathology and immunohistochemistry report. | Posted | Count of Participants | Participants | Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) |
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From first injection (earliest dosing visit at Day -43) up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) for CCH injection treatment and up to end of study (Day 28 post-abdominoplasty surgery follow-up visit)
Adverse events were collected throughout the study (up to Day 28 post-abdominoplasty surgery follow-up visit). Adverse events associated with local tolerability in treatment areas injected with CCH were collected up to the day abdominal tissue was excised.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: CCH Single Injection Technique | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
This was considered an exploratory study by the Sponsor. No formal sample size calculations were performed. Completion of 8 participants provided minimal data to meet the primary objective in the evaluable population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saji Vijayan, MBBS | Endo Pharmaceuticals | 800-462-3636 | clinicaltrials@endo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2020 | Sep 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2020 | Sep 23, 2021 | SAP_001.pdf |
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| Group 5: CCH Multiple Injection Technique | Experimental | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. |
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| Group 6: CCH Multiple Injection Technique | Experimental | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. |
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| Collagenase Clostridium Histolyticum Multiple Injection Technique | Drug | CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg. |
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| Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) |
| Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment | Serum samples were analyzed for anti-AUX-I clostridial class I collagenase of ADAs and anti-AUX-II Clostridial class II collagenase of ADAs. The number of participants who developed anti-AUX-I and anti-AUX-II ADAs (positive ADA result) are reported. | End of Study (Day 28) |
| Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment | Serum samples were analyzed for anti-AUX-I and Anti-AUX-II Nabs. The number of participants who developed anti-AUX-I and Anti-AUX-II NAbs (positive NAb results) are reported. Neutralizing antibodies were only tested from ADA positive participants. | End of Study (Day 28) |
| New York |
| New York |
| 10021 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg |
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| Height | Mean | Standard Deviation | cm |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| OG001 | Group 2: CCH Single Injection Technique | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. |
| OG002 | Group 3: CCH Single Injection Technique | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. |
| OG003 | Group 4: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. |
| OG004 | Group 5: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. |
| OG005 | Group 6: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. |
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| Secondary | Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection | Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in a tissue specimen injected with 2 CCH dose injections (Treatment Area 1) relative to 1 CCH dose injection (Treatment Area 2) is reported. | Evaluable Population: All participants who received at least 1 injection of study drug, underwent abdominoplasty within the protocol specified timelines, and had a histopathology and immunohistochemistry report. | Posted | Count of Participants | Participants | Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) |
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| Secondary | Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment | Serum samples were analyzed for anti-AUX-I clostridial class I collagenase of ADAs and anti-AUX-II Clostridial class II collagenase of ADAs. The number of participants who developed anti-AUX-I and anti-AUX-II ADAs (positive ADA result) are reported. | Safety Population: All participants who received at least 1 injection of study drug irrespective of the timing window of abdominoplasty. ADA data is reported as overall population instead of individual groups due to the small number of participants per arm and to protect PII of the participants. | Posted | Count of Participants | Participants | End of Study (Day 28) |
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| Secondary | Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment | Serum samples were analyzed for anti-AUX-I and Anti-AUX-II Nabs. The number of participants who developed anti-AUX-I and Anti-AUX-II NAbs (positive NAb results) are reported. Neutralizing antibodies were only tested from ADA positive participants. | All participants who received at least 1 injection of study drug and were positive for ADAs. NAb data is reported as overall analysis population instead of individual groups due to the small number of participants per arm and to protect PII of the participants. | Posted | Count of Participants | Participants | End of Study (Day 28) |
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| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Group 2: CCH Single Injection Technique | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Group 3: CCH Single Injection Technique | Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Group 4: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked (Area 1 and Area 2) areas of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG004 | Group 5: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | Group 6: CCH Multiple Injection Technique | Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. | 0 | 1 | 0 | 1 | 1 | 1 |
| Injection site bruising | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Postoperative wound infection | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Post procedural erythema | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Umbilical erythema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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