A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

Study Overview
=================
Brief Summary
-----------------
Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871.

Official Title
-----------------
A Long-term Efficacy Assessment Following Initial Scar Revision Surgery And Phase 2 Open-label Study To Evaluate Safety Of Re-treatment With Pf-06473871

Conditions
-----------------
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery

Intervention / Treatment
-----------------
* Drug: PF-06473871
* Drug: PF-06473871


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects previously randomized to Pfizer clinical study B5301001. Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation and local anesthesia. Exclusion Criteria: Pregnant female subject; breastfeeding female subjects; male subjects with partners currently pregnant. Any previous history of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 57 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses). | Drug: PF-06473871<br>* Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.<br>|
| Experimental: Group 2<br>The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses). | Drug: PF-06473871<br>* Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit | Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). | 52 weeks after initial scar revision surgery in study B5301001 | 
| Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure. | Part B: Baseline up to Week 15 | 
| Part B: Number of Participants With Clinical Laboratory Abnormalities | Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed. | Part B: Baseline up to Week 15 | 
| Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) | An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A. | Part B: Baseline up to Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit | Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). | 52 weeks after initial scar revision surgery in study B5301001 | 
| Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit | PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. | 52 weeks after initial scar revision surgery in study B5301001 | 
| Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit | Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). | 52 weeks after initial scar revision surgery in study B5301001 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 2, open-label, safety, hypertrophic scar revision surgery