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

Phase 2

Terminated

• Conditions: Keloids
• Interventions: Drug: QAX576 placebo; Drug: QAX576

• Registration Number: NCT00987545
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-02
• Disposition First Submitted QC: 2012-05-02
• Disposition First Posted: 2012-05-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	QAX576 placebo	-
QAX576	QAX576	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

TKL Research, Inc; 🇺🇸 Paramus, New Jersey, United States

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

Skin Search of Rochester/Dermatology Associates; 🇺🇸 Rochester, New York, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States