CompletedNCT06477237Updated Oct 22, 2026

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

A Phase 3 interventional study of HB0017 Q4W and HB0017 Q8W in Psoriasis, sponsored by Huabo Biopharm Co., Ltd.. Completed at 44 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Huabo Biopharm Co., Ltd. · Phase 3, Interventional, and Treatment

Updated Oct 22, 2026Now CompletedStart date moved+3 moreGo to Updates ↓

Phase: Phase 3
Study type: Interventional
Enrollment: 408
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Psoriasis

Browse trials for

Psoriasis 1,928

Keywords

psoriasis; HB0017

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 408 is above the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Huabo Biopharm Co., Ltd. is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

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

Key Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 408 participants (actual)

Study arms

Experimental
HB0017
Participants 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.
Biological: HB0017 Q4W · Biological: HB0017 Q8W
Placebo comparator
placebo
Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
Biological: placebo

Interventions

BiologicalHB0017 Q4W
HB0017 at W0,1,2,4,8+HB0017Q4W
BiologicalHB0017 Q8W
HB0017 at W0,1,2,4,8+HB0017Q8W
Biologicalplacebo
placebo at W0,1,2,4,8+HB0017Q4W

What researchers measure

Primary outcomes

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
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

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
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
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
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

Study locations

44 sites

Jiangmen Central Hospital
Jiangmen, Guangdong, China
Nanyang First People's Hospital
Nanyang, Henan, China
Beijing Friendship Hospital
Beijing, China
China-Japan Friendship hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Jilin University Second Hospital
Changchun, China
The first hospital of Jilin University
Changchun, China
Xiangya Hospital of Central South University
Changsha, China
Affiliated Hospital of Chengde Medical University
Chengde, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, China
Dongguan People's Hospital
Dongguan, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Hangzhou First People's Hospital
Hangzhou, China
Hangzhou Third People's Hospital
Hangzhou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Jiaxing First Hospital
Jiaxing, China
Shandong Dermatology Hospital
Jinan, China
Jining First People's Hospital
Jining, China
The First Affiliated Hospital of Kunming Medical University
Kunming, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Dermatology Hospital of Jiangxi Province
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu University Affiliated Hospital
Nanjing, China
Ningbo Second Hospital
Ningbo, China
Shanghai Dermatology Hospital
Shanghai, China
People's Hospital of Liaoning Province
Shenyang, China
Shenzhen People's Hospital
Shenzhen, China
Shiyan People's Hospital
Shiyan, China
The Second Hospital of Shanxi Medical University
Taiyuan, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, China
Wuhan University People's Hospital
Wuhan, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, China
Wuxi Second People's Hospital
Wuxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xingtai People's Hospital
Xingtai, China
Yangjiang People's Hospital
Yangjiang, China

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Nov 2024, 7 months.

Of 173 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 7 months is below that.

Counting every sponsor, half of 180 studies reached it within 16 months; a quarter within 10 and three quarters within 25.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Aug 2024 → Nov 2024 and completion Dec 2025 → Oct 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered: Jun 18, 2024
First posted: Jun 27, 2024
StartActual: Mar 29, 2024
Primary completionActual: Nov 15, 2024was Aug 2024
CompletionActual: Oct 31, 2025was Dec 2025
Last update: Oct 22, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Status

Status unknown→Completed

changed Oct 22, 2026

Start date

Mar 1, 2024→Mar 29, 2024

Oct 22, 2026

Primary completion

Aug 2024→Nov 15, 2024 (actual)

Oct 22, 2026

Study completion

Dec 2025→Oct 31, 2025 (actual)

Oct 22, 2026

Enrollment

400 (estimated)→408 (actual)

Oct 22, 2026

Show all 1 update

Oct 22, 2026
Status unknown→Completed
Start date Mar 1, 2024→Mar 29, 2024
Primary completion Aug 2024→Nov 15, 2024 (now actual)
Study completion Dec 2025→Oct 31, 2025 (now actual)
Enrollment 400 (estimated)→408 (actual)
+ 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06477237
Lead sponsor: Huabo Biopharm Co., Ltd.
Responsible party: Sponsor
First posted: Jun 27, 2024
Start date: Mar 29, 2024
Primary completion: Nov 15, 2024
Completion: Oct 31, 2025
Last update: Oct 22, 2026

Study contacts

Jianzhong Zhang, MD

principal investigator · Peking University People's Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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