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

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

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.

Study Overview

• Status: Terminated
• Conditions: Keloids
• Intervention / Treatment: Drug: QAX576 placebo; Drug: QAX576

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • TKL Research, Inc
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester/Dermatology Associates
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: QAX576 placebo; Placebo to QAX576 injection
Experimental: QAX576	Drug: QAX576; QAX576 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: TKL Research, Inc.; Virginia Clinical Research, Inc.; Dermatology Consulting Services, High Point NC; Skin Search

Publications and helpful links

Helpful Links

• Results for CQAX576A2206 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: recurrence; Keloids
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Recurrence; Keloid
• Other Study ID Numbers: CQAX576A2206