Jianzhong Zhang
Beijing, Beijing Municipality, China
NCT Number: NCT06094179
This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.
This study is active but is not currently recruiting participants.
18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In) :
Glucocorticoids (TCS); Calcineurin inhibitors or other immunosuppressants; JAK inhibitor; Antipruritic agents such as clomitone; Compound preparations containing corticosteroids or calcineurin inhibitors or other immunosuppressants; Prescription emollients that affect AD; Chinese herbal medicine, proprietary Chinese medicine and ethnic medicine for AD;
300mg Q4W group, 600mg Q4W group (at week 0,4,8,12) and 600mg Q2W group (at week 0,2,4,6,8,10,12,14)
Other names: BAT6026
300mg Q4W group, 600mg Q4W group (at week 0,4,8,12) and 600mg Q2W group (at week 0,2,4,6,8,10,12,14)
Time frame: The last patient in each group was dosed 1 week later
Incidence of AE above 3 Arms associated with the test drug in each dose group
Time frame: The last patient in each group was dosed 1 week later
Number of participants with abnormal vital signs
Time frame: The last patient in each group was dosed 1 week later
Number of participants with abnormal ECG readings
Time frame: The last patient in each group was dosed 1 week later
Number of participants with abnormal laboratory test results
Time frame: The last patient in each group was dosed 1 week later
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Bio-Thera Solutions
Industry
A Study Evaluated the Safety and Efficacy of BAT6026 in Patients With Moderate to Severe Atopic Dermatitis Phase I/II Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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