Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence

Study Overview
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Brief Summary
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This is a 2-part study. In the first part (Part I, 8 subjects), biopsies will be obtained from the resection site after keloid shaving and two weeks following resection to assess and select biomarkers to determine the biologic effects that occur in shaved keloids. No drug will be administered. In Part II (32 patients) will be randomized to receive QAX576 or placebo. An initial drug infusion will be followed by shave removal of keloids 6 - 8 days later followed by two additional drug infusions 4 weeks apart. Two weeks following resection, punch biopsies will be performed to assess biomarker responses. Patients will be followed-up for 52 weeks after first drug administration to assess keloid recurrence (clinically and by 3D imaging), and by physician's and patient's cosmetic assessments, and safety.

Official Title
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A Post-shave Keloid Recurrence Study in Two Parts: A Biomarker Assessment Followed by a Randomized, Double-blind, Placebo Controlled Evaluation of Safety, Tolerability, and Efficacy of QAX576

Conditions
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Keloids

Intervention / Treatment
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* Drug: QAX576
* Drug: QAX576 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with two or more keloids on the trunk, upper extremities or thighs. The keloids must meet specified size criteria and have been present for greater than or equal to 1 year, been stable in size and symptoms for at least 6 months. Exclusion Criteria: Use of other investigational drugs at the time of enrollment, or history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. lidocaine, epinephrine, and topical antibiotics as bacitracin and neomycin). History of repeated recurrence of keloid after prior surgical removal (4-5 times removed). Keloids near the hands, joints, and anogenital areas as recurrence might cause significant problems. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study Other protocol-defined inclusion/exclusion criteria may apply.

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

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: QAX576 placebo<br>* Placebo to QAX576 injection<br>|
| Experimental: QAX576<br> | Drug: QAX576<br>* QAX576 injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of keloids after shave removal. |  | At 13 weeks and 26 weeks with a follow up visit at 52 weeks after the first infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the mechanism biomarker responses post-shave removal of keloids for confirmation in Part I and application in Part II |  | Two weeks post-shave removal of keloids | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keloids, recurrence