Psoriasis (PsO)Phase 2HB0017NCT06592274
A Phase 2 Study of HB0017 in Psoriasis Patients
A Phase 2 study testing HB0017 in people with Psoriasis (PsO), run by Huabo Biopharm Co., Ltd. at 18 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis (PsO)
- What is being tested?
- HB0017
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 18 sitesChina
- Study dates
- 30 Sep 2024to 10 Apr 2026
- Phase
- Phase 2
- 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
- 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
18 sites in 1 country.
18 sites in 1 country
China18 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Jilin University Second Hospital
Changchun, Jilin
Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Sichuan
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong
Guangdong Provincial People's Hospital
Guangzhou
Hangzhou First People's Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jiaxing First Hospital
Jiaxing, Zhejiang
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, 0531
Jining First People's Hospital
Jining, Shandong, 0531
Ningbo Second Hospital
Ningbo
Shanxi Medical University Second Hospital
Taiyuan, Shanxi
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang
Wuxi Second People's Hospital
Wuxi, Jiangsu
Xingtai People's Hospital
Xingtai, Shandong, 0531
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu
About this study
Official title: A Multicenter, Randomized, Double-blind Phase 2 Clinical Study Evaluating the Efficacy and Safety of Different Administration Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
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
- Conditions
- Psoriasis (PsO)
- Being tested
- HB0017
- Keywords
- HB0017, psoriasis, longer dose regimen
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0017Biological
300mg Q12W
HB0017Biological
300mg Q8W
HB0017Biological
150mg Q4W
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | HB0017 higer dose plus longer dose regimen Receives: Biological: HB0017 |
| Experimental Group 2 | Experimental | HB0017 higer dose plus shorter dose regimen Receives: Biological: HB0017 |
| Experimental Group 3 | Experimental | HB0017 low dose plus shortest dose regimen Receives: Biological: HB0017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving PASI 90 response
The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Measured: Week 12
Proportion of subjects achieving sPGA 0/1
The sPGA is a physician\&#39;s determination of the participant\&#39;s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant\&#39;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)
Proportion of subjects achieving PASI 75 response
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Measured: Week 12
Proportion of subjects achieving PASI 100 response
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline
Measured: Week 12
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
Measured: Week12-48
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.
Measured: Week12-48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completion30 Apr 2025
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592274
- Sponsor's protocol ID
- HB0017-PsO-02-02
- Acronym
- HB0017
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Phase 2 Clinical Study Evaluating the Efficacy and Safety of Different Administration Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06592274
- Acronym / sponsor ID
- HB0017 / HB0017-PsO-02-02
- Conditions
- Psoriasis (PsO)
- Keywords
- HB0017, psoriasis, longer dose regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Biological: HB0017HB0017 higer dose plus longer dose regimen |
| Experimental Group 2 | Experimental | Biological: HB0017HB0017 higer dose plus shorter dose regimen |
| Experimental Group 3 | Experimental | Biological: HB0017HB0017 low dose plus shortest dose regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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) \&gt;=12 and body surface area (BSA) affected by PSO \&gt;=10% and Static Physician Global Assessment (sPGA) score \&gt;=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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB0017300mg Q12W | Biological | Experimental Group 1 |
| HB0017300mg Q8W | Biological | Experimental Group 2 |
| HB0017150mg Q4W | Biological | Experimental Group 3 |
Primary outcome
Proportion of subjects achieving PASI 90 response
Time frame: Week 12
The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1
Time frame: Week 12
The sPGA is a physician\&#39;s determination of the participant\&#39;s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant\&#39;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.
4 secondary outcomes
Proportion of subjects achieving PASI 75 response
Time frame: Week 12
Proportion of subjects achieving PASI 100 response
Time frame: Week 12
PASI 90 response maintainance at week 48
Time frame: Week12-48
sPGA 0/1 response maintainance at week 48
Time frame: Week12-48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB0017 in people with Psoriasis (PsO), run by Huabo Biopharm Co., Ltd. at 18 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 8 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 23 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 18 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 90 response (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?
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 23 Oct 2026.