Generalized Pustular PsoriasisPhase 2/3NCT06477536
Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis
A Phase 2/3 study testing HB0034 in people with Generalized Pustular Psoriasis, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- HB0034
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesChina
- Study dates
- 2 Sep 2024to 30 Jun 2026
- Phase
- Phase 2/3
- 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
- Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study
- Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
- Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;
- Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules
Who cannot join
- Patients who are experiencing GPP flare
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Peking University People's Hospital (PKUPH)
Beijing
Jianzhong zhang, +8618555690860, qiaoxia.qian@huata.com
Jianzhong zhang, PhD
- Recruiting
Peking University People's Hospital
Beijing
- Recruiting
The Second affiliated Hospital zhejiang University School of Medicine
Hangzhou
Xiaoyong Man, Phd, +86 18555690860, xiaoyong.man@gmail.com
About this study
Official title: A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).
Read the detailed description
This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- HB0034
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0034Drug
Also called Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody
300mg, i.v. Q4W
| Study group | Role | What they receive |
|---|---|---|
| HB0034 | Experimental | single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks Receives: Drug: HB0034 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints include the proportion of subjects with TEAEs
The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG).
Measured: 0-24 weeks
Secondary outcomes (1)
The recurrence of GPP flare during the study
The Proportion of patients who have at least once GPP flare during the study
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start2 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies of the same condition, open and under way.
- More trials run by Shanghai Huaota Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, PhD, Principal investigator, Peking University People's Hospital (PKUPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477536
- Sponsor's protocol ID
- HB0034-05
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT06477536
- Acronym / sponsor ID
- HB0034-05
- Conditions
- Generalized Pustular Psoriasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Jun 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 is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).
Detailed description
This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HB0034 | Experimental | Drug: HB0034single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study
- Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
- Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;
- Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules
Key exclusion criteria (1 listed)
- Patients who are experiencing GPP flare
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 |
|---|---|---|
| HB0034Also: Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody300mg, i.v. Q4W | Drug | HB0034 |
Primary outcome
Safety endpoints include the proportion of subjects with TEAEs
Time frame: 0-24 weeks
The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG).
1 secondary outcome
The recurrence of GPP flare during the study
Time frame: 0-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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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.
Jianzhong Zhang, PhD principal investigator
Peking University People's Hospital (PKUPH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HB0034 in people with Generalized Pustular Psoriasis, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 3 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guodong Zhou (+86 13636638684, guodong.zhou@huaota.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoints include the proportion of subjects with TEAEs (time frame: 0-24 weeks). 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 14 Feb 2025.