Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma
ConditionSevere Asthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOneness Biotech Co., Ltd.
About this trial
This is a randomized, placebo controlled and double blind study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe asthma. The study comprised a 4-week screening period, a 8-week treatment period and a 12-week follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
FB704A placebo
Biological/VaccinePlacebo
FB704A
Biological/VaccineAnti-IL-6 antibody
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: FB704A placeboPlacebo comparator 1 intervention
Group B: FB704AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of the number of Adverse Event reported during the treatment period
AE
Time frame
Day 57Secondary outcomes
1
Change from baseline in blood neutrophil counts
neutrophil counts
Time frame
Day 36, 57, 85, 113, and 1412
Change from baseline in sputum neutrophil counts
neutrophil counts
Time frame
Day 573
ACT score
The ACT Score \> 19 means well controlled.
Time frame
Day 36, 57, 85, and 1414
Change from baseline in Asthma control test (ACT)
The ACT Score \> 19 means well controlled.
Time frame
Day 36, 57, 85, and 141Other outcomes
1
Change in IL-6
IL-6
Time frame
during the study (8 weeks treatment period and 12 weeks follow upSponsors and contacts
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Source ClinicalTrials.gov