A Phase 2 interventional study of Pascolizumab and Placebo in Tuberculosis, Pulmonary, sponsored by National University Hospital, Singapore. Status unknown at 7 sites in 3 countries. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 32 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The dose of study medication will be calculated using the patient's body weight and the appropriate dosing regimen based on the cohort of enrollment. The medication will be administered by slow intravenous infusion over 1 hour under close medical supervision.
Drug: Pascolizumab
For patients randomized to placebo, Sterile 0.9% w/v Sodium Chloride will be used for Injection, using the same volume that would have been prepared if the patient had been randomized to receive pascolizumab.
Drug: Placebo
0.05mg/kg - 10mg/kg Pascolizumab according to dosing cohort
Saline (volume determined based on weight of patient, and cohort of enrollment)
Efficacy - Time to detection on liquid culture of sputum on Week 8
Time frame: 8 weeks post intervention
Co-primary outcome measure - safety
Adverse events considered at least possibly related to study medication and that are classified by the site investigator as serious and/or grade IV severity
Time frame: Upto 24 weeks via follow-up visits/assessments and 24-96 weeks via phone assessments
Sputum culture status (positive or negative) on liquid culture at week 8
Time frame: 8 weeks
Rate of change (area under the curve) from baseline to week 8 in the time to positivity in liquid culture of sputum
Time frame: 8 weeks
Rate of change in serial sputum colony counts on solid cultures from baseline to week 8
Time frame: 8 weeks
Rate of change of RPF-dependent serial sputum colony counts from baseline to week 8
Time frame: 8 weeks
Sputum culture status (positive or negative) on solid culture at week 8
Time frame: 8 weeks
Rate of change of sputum smear lipid-body positive mycobacteria from baseline to week 8
Time frame: 8 weeks
Serum IL-4 levels (free and drug-bound)
Time frame: 24 weeks
Time to resolution of fever
Time frame: 24 weeks
Time to resolution of all TB symptoms
Time frame: 24 weeks
Resolution of chest X-ray changes at week 24
Time frame: 24 weeks
Resolution of PET/MRI changes at week 8 and week 24
Time frame: 24 weeks
TB relapse at any time up to week 96
Time frame: 96 weeks
Anti-pascolizumab antibodies
Time frame: 24 weeks
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore