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PsoriasisPhase 3NCT06477237

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

A Phase 3 study testing HB0017 Q4W and HB0017 Q8W in people with Psoriasis, run by Huabo Biopharm Co., Ltd. at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
HB0017 Q4W and HB0017 Q8W
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
44 sitesChina
Study dates
29 Mar 2024to 31 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Subjects who are able to use effective contraception from the screening period to 6 months after the last dose

Who cannot join

  • 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
  • Have previously received any drug that directly targets IL-17 or IL-17 receptor
Show all 9Show fewer
  • Have concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab and adalimumab <60 days; golimumab < 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs <6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
  • A history of inflammatory bowel disease or other serious autoimmune disease
  • Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Beijing Friendship Hospital

    Beijing

  • China-Japan Friendship hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Jilin University Second Hospital

    Changchun

  • The first hospital of Jilin University

    Changchun

  • Xiangya Hospital of Central South University

    Changsha

  • Affiliated Hospital of Chengde Medical University

    Chengde

  • Sichuan Provincial People's Hospital

    Chengdu

  • West China Hospital of Sichuan University

    Chengdu

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing

  • Dongguan People's Hospital

    Dongguan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Dermatology Hospital of Southern Medical University

    Guangzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Hangzhou First People's Hospital

    Hangzhou

  • Hangzhou Third People's Hospital

    Hangzhou

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

  • Jiaxing First Hospital

    Jiaxing

  • Shandong Dermatology Hospital

    Jinan

  • Jining First People's Hospital

    Jining

  • The First Affiliated Hospital of Kunming Medical University

    Kunming

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang

  • Dermatology Hospital of Jiangxi Province

    Nanchang

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu University Affiliated Hospital

    Nanjing

  • Nanyang First People's Hospital

    Nanyang, Henan

  • Ningbo Second Hospital

    Ningbo

  • Shanghai Dermatology Hospital

    Shanghai

  • People's Hospital of Liaoning Province

    Shenyang

  • Shenzhen People's Hospital

    Shenzhen

  • Shiyan People's Hospital

    Shiyan

  • The Second Hospital of Shanxi Medical University

    Taiyuan

  • Wenzhou Medical University Affiliated First Hospital

    Wenzhou

  • Wuhan University People's Hospital

    Wuhan

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu

  • Wuxi Second People's Hospital

    Wuxi

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xingtai People's Hospital

    Xingtai

  • Yangjiang People's Hospital

    Yangjiang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

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.

Conditions
Psoriasis
Being tested
HB0017 Q4W, HB0017 Q8W, placebo
Keywords
psoriasis; HB0017
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HB0017 Q4WBiological

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

  • HB0017 Q8WBiological

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

  • placeboBiological

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

Study groups in NCT06477237
Study groupRoleWhat they receive
HB0017ExperimentalParticipants will receive HB0017 at week 0,1,2,4,8 followed by once every four weeks (Q4W) or once every eight weeks (Q8W) at Week 12.
Receives: Biological: HB0017 Q4W; Biological: HB0017 Q8W
placeboPlacebo comparatorParticipants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Week 12

Secondary outcomes (4)

  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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: Week12-52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study start29 Mar 2024
  3. Primary completion15 Nov 2024
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06477237
Sponsor's protocol ID
HB0017-07
Status last verified
Jun 2024
First submitted
18 Jun 2024
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HB0017 Q4W and HB0017 Q8W in people with Psoriasis, run by Huabo Biopharm Co., Ltd. at 44 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving PASI 75 response at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06477237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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