Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

Study Overview
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Brief Summary
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The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.

Official Title
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A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

Conditions
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Scar Formation

Intervention / Treatment
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* Biological: GBT009
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study: be a female between 18 and 70 years of age, inclusive have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive be scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique for women diagnosed with breast cancer, has standard of care treatment for breast cancer prior to surgery and will have standard of care treatment for breast cancer after surgery for subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA through completion of the study and have negative results on a serum pregnancy test done before administration of study medication (women who are postmenopausal [no menses for at least 2 years] are also eligible to participate) be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participating in the study: have clinically significant laboratory abnormalities at screening have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening have a life expectancy ≤ 2 years have a history of alcoholism or drug addiction or abuse within 5 years have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing have a history of keloid scar formation have existing scarring in the abdominal area of study that would interfere with the efficacy assessments have a history of (within the past 5 years) or an active malignancy, other than breast cancer have a breast cancer that has been staged at Stage IIIB, IIIC or IV have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication have received anticoagulation medication within 5 days of dosing with study medication have participated in any study involving an investigational product within 30 days before dosing with study medication have routinely used tobacco products within 6 months preceding the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GBT009<br> | Biological: GBT009<br>* Intradermal Injection following surgery<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Intradermal Injection following surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photography- Independent Scar Assessment Panel | An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed. | 0.5, 1, 2, 3, 6, 9 and 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Scar Preference | Overall preference of the healing/appearance of each scar segment as completed by investigator and subject. | 12 Month (End of Study) | 
| Patient Observer Scar Assessment Scale (POSAS) | Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months) | 12 Month (End of Study) | 
| Manchester Scar Scale (MSS) | Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales. MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions. Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4). Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4). Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months) | 12 Month (End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBT009, incisional scar, breast reconstruction