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Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuabo Biopharm Co., Ltd.

About this trial

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged 18-75 years (inclusive)

Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.

Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.

Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator

Disqualifiers

Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline

Drug-induced psoriasis

Ongoing use of prohibited treatments

Any active infection (other than common cold) within 14 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • HB0017 Q4W

    Biological/Vaccine

    HB0017 at W0,1,2,4,8+HB0017Q4W

  • HB0017 Q8W

    Biological/Vaccine

    HB0017 at W0,1,2,4,8+HB0017Q8W

  • placebo

    Biological/Vaccine

    placebo at W0,1,2,4,8+HB0017Q4W

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: HB0017Experimental treatment 2 interventions
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving PASI 75 response at Week 12

The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.

Time frame
Week 12
2

Proportion of subjects achieving sPGA 0/1 response at Week 12

The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1.

Time frame
Week 12

Secondary outcomes

1

Proportion of subjects achieving PASI 90 response at Week 12

The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline.

Time frame
Week 12
2

PASI 90 response maintainance at week 52

Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12

Time frame
Week12-52
3

sPGA 0/1 response maintainance at week 52

Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12.

Time frame
Week 12-52
4

PASI 75 response maintainance at week 52

Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12.

Time frame
Week12-52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huabo Biopharm Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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