A Phase 2 interventional study of QAX576 and QAX576 placebo in Keloids, sponsored by Novartis Pharmaceuticals. Terminated at 4 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
123 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's enrollment of 3 is below the median of 30 across 97 interventional studies indexed under Keloid.
Browse Keloid studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Drug: QAX576 placebo
Drug: QAX576
QAX576 injection
Placebo to QAX576 injection
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
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
This study is terminated, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals