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

Primary Purpose

Keloids

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QAX576
QAX576 placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloids focused on measuring Keloids, recurrence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TKL Research, Inc
  • Skin Search of Rochester/Dermatology Associates
  • Dermatology Consulting Services
  • Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

QAX576

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of keloids after shave removal.

Secondary Outcome Measures

To assess the mechanism biomarker responses post-shave removal of keloids for confirmation in Part I and application in Part II

Full Information

First Posted
September 30, 2009
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
Collaborators
TKL Research, Inc., Dermatology Consulting Services, High Point NC, Skin Search, Virginia Clinical Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00987545
Brief Title
Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Negative pharmacodynamics due to lack of Interleukin-13 signature in biomarker data from Part I of the study.
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
TKL Research, Inc., Dermatology Consulting Services, High Point NC, Skin Search, Virginia Clinical Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloids
Keywords
Keloids, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
QAX576
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
QAX576
Intervention Description
QAX576 injection
Intervention Type
Drug
Intervention Name(s)
QAX576 placebo
Intervention Description
Placebo to QAX576 injection
Primary Outcome Measure Information:
Title
Recurrence of keloids after shave removal.
Time Frame
At 13 weeks and 26 weeks with a follow up visit at 52 weeks after the first infusion
Secondary Outcome Measure Information:
Title
To assess the mechanism biomarker responses post-shave removal of keloids for confirmation in Part I and application in Part II
Time Frame
Two weeks post-shave removal of keloids

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
TKL Research, Inc
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Skin Search of Rochester/Dermatology Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5685
Description
Results for CQAX576A2206 from the Novartis Clinical Trials website

Learn more about this trial

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

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