Study Stopped
Negative pharmacodynamics due to lack of Interleukin-13 signature in biomarker data from Part I of the study.
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
1 other identifier
interventional
3
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedDecember 19, 2020
May 1, 2012
1.4 years
September 30, 2009
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
Placebo
PLACEBO COMPARATORQAX576
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- TKL Research, Inc.collaborator
- Dermatology Consulting Services, High Point NCcollaborator
- Skin Searchcollaborator
- Virginia Clinical Research, Inc.collaborator
Study Sites (4)
TKL Research, Inc
Paramus, New Jersey, 07652, United States
Skin Search of Rochester/Dermatology Associates
Rochester, New York, 14623, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 19, 2020
Record last verified: 2012-05