Tuberculosis, Pulmonary Clinical Trial
Official title:
Safety and Efficacy of Blocking IL-4 With Pascolizumab in Patients Receiving Standard Combination Therapy for Pulmonary Tuberculosis (TB): a Randomized, Double-blind, Placebo-controlled, Proof-of-concept Clinical Trial
New approaches are needed to achieve more rapid elimination of dormant mycobacteria and
thereby shorten treatment for drug-sensitive and drug-resistant tuberculosis (TB). Dormant
mycobacteria are relatively resistant to antibacterial drugs and approaches that enhance
immune clearance have the potential to be more effective. Interleukin-4 (IL-4) is a key
cytokine in the immune response to TB that may impair the clearance of mycobacteria. We
hypothesize that pascolizumab, an anti-IL-4 monoclonal antibody, might be of value as an
adjunct to standard treatment.
The aims of this trial are to determine whether administration of pascolizumab as an adjunct
to standard combination treatment for drug-sensitive TB produces changes in one or more
parameters of bacterial or host response (including bacterial clearance, host clinical
status, immune response, bacterial and host transcriptomics, lung imaging) that may indicate
potential for enhanced sterilization and to confirm the safety of blocking IL-4 (previously
demonstrated in healthy volunteers and patients with asthma) in patients with TB.
n/a
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