Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Huaota Biopharmaceutical Co., Ltd.

About this trial

This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients participated in the preceding placebo-controlled Phase 2 study (HB0034-04)and completed at least the Week 12 visit of the HB0034-04 study

Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment

Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;

Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules

Disqualifiers

Patients who are experiencing GPP flare

Trial design

Design model

Single group

Treatments tested in this trial

  • HB0034

    Drug

    300mg, i.v. Q4W

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: HB0034Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety endpoints include the proportion of subjects with TEAEs

The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG).

Time frame
0-24 weeks

Secondary outcomes

1

The recurrence of GPP flare during the study

The Proportion of patients who have at least once GPP flare during the study

Time frame
0-24 weeks

Other outcomes

Sponsors and contacts

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