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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05512598
Other study ID # HB0034-02
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 6, 2022
Est. completion date January 10, 2024

Study information

Verified date January 2024
Source Shanghai Huaota Biopharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).


Description:

This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HB0034
HB0034, a single dose

Locations

Country Name City State
China Dermatology Hospital of Shandong First Medical University Shandong Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Huaota Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with drug related adverse events An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug 90 days
Secondary Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared) efficacy outcome of investigational drug 12 weeks
Secondary Cmax The maximum measured concentration of the analysis in plasma 12 weeks
Secondary AUC0-infinity The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity 12 weeks
See also
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Completed NCT05200247 - An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options Phase 3
Active, not recruiting NCT05366855 - Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis Phase 3
Completed NCT05352893 - Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP Phase 3