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A Phase 2 Study of HB0017 in Psoriasis Patients

ConditionPsoriasis (PsO)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuabo Biopharm Co., Ltd.

About this trial

This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects

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

Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization

Trial design

Design model

Parallel

Treatments tested in this trial

  • HB0017

    Biological/Vaccine

    300mg Q12W

  • HB0017

    Biological/Vaccine

    300mg Q8W

  • HB0017

    Biological/Vaccine

    150mg Q4W

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Experimental Group 1Experimental treatment 1 intervention
Group B: Experimental Group 2Experimental treatment 1 intervention
Group C: Experimental Group 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving PASI 90 response

The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.

Time frame
Week 12
2

Proportion of subjects achieving sPGA 0/1

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 75 response

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 PASI 100 response

The PASI100 response assessments are based on 100% improvement in PASI score from Baseline

Time frame
Week 12
3

PASI 90 response maintainance at week 48

Proportion of subjects maintaining PASI 90 response at Week 48 among those with PASI 90 response at Week 12

Time frame
Week12-48
4

sPGA 0/1 response maintainance at week 48

Proportion of subjects maintaining sPGA 0/1 response at Week 48 among those with sPGA 0/1 response at Week 12.

Time frame
Week12-48

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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