Generalized Pustular Psoriasis (GPP)Phase 2NCT06231381
Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)
A Phase 2 study testing HB0034 in people with Generalized Pustular Psoriasis (GPP), run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Pustular Psoriasis (GPP)
- What is being tested?
- HB0034
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesChina
- Study dates
- 29 Feb 2024to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 must be experiencing an acute GPP flare of moderate-to-severe intensity at baseline, defined as:
- A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of ≥ 3;
- New appearance or worsening of existing pustules, and a GPPGA pustulation subscore of ≥ 2;
- ≥ 5% Body Surface Area (BSA) covered with pustules.
- 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
- Drug-triggered acute generalized exanthematous pustulosis (AGEP);
- Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO);
- Other active inflammatory or autoimmune diseases requiring systemic treatment with immunosuppressants, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), inflammatory bowel disease, and uveitis.
- Patients with an increased risk of infectious complications as assessed by the investigator (e.g., a recent suppurative infection, any congenital or acquired immunodeficiency, such as HIV infection, prior organ or stem cell transplantation);
- Patients who have received a live vaccine or investigational live vaccine within 6 weeks prior to the first dose of the study drug, or plan to receive a live vaccine or participate in a clinical study of investigational live vaccine during the study period or within 6 weeks after completion of administration of the study drug;
- Patients who have had a serious trauma or undergone a major surgery within 1 month prior to the first dose of the study drug, or plan to undergo any elective surgery during the study period;
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- Patients with documented active or suspected malignancy or a history of malignancy within 5 years prior to screening;
- Patients with a history of severe allergy, who have experienced grade 3-4 allergic reactions when receiving other monoclonal antibodies, or those who are known to have hypersensitivity to protein drugs, recombinant proteins, or HB0034 components;
- Subjects who are pregnant or breastfeeding, or those who have a positive pregnancy test result. Breastfeeding female subjects who stop breastfeeding prior to the first dose of the study drug until 16 weeks after the end of the trial will not be excluded;
- Patients who are currently participating in clinical trials or have participated in clinical trials of any drug/device within 30 days (or 5 half-lives, whichever is longer) prior to the first dose of the study drug;
- Patients expected to have poor compliance, such as those who are uncooperative, fail to receive follow-up on time, and are unlikely to complete the study;
- Other reasons that the investigator considers it is inappropriate to participate in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University People's Hospital (PKUPH)
Beijing
Jianzhong Zhang, Phd
- Recruiting
Shanghai Huaota Biopharmaceutical Co., Ltd
Shanghai
zhou guodong, +86 13636638684, guodong.zhou@huaota.com
About this study
Official title: A Phase II, Multicenter, Double-blind, Randomized, Placebo Parallel-controlled Trial to Evaluate the Efficacy and Safety of HB0034 in Patients with GPP Presenting with an Acute Flare of Moderate to Severe Intensity
This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
Read the detailed description
GPP patients who are experiencing an acute flare will be screened. Before randomization, the investigator must ensure that the subjects meet all inclusion criteria and do not meet any exclusion criteria.
Subjects will be given a single intravenous infusion of HB0034 or placebo (2:1) on D1 and be hospitalized for at least 8 days after administration of the study drug (including Day 1 for administration). Thereafter, the decision of the patient's discharge will be left at the discretion of the investigator and based on the evolution of the GPP flare and the patient's health status.
Subjects will be followed up to W12-W20.
- Conditions
- Generalized Pustular Psoriasis (GPP)
- Being tested
- HB0034, Placebo
- 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 Recombinant Humanized anti-IL-36R Monoclonal antibody
Anti-IL-36R antibody
PlaceboOther
non-biologically active drug
| Study group | Role | What they receive |
|---|---|---|
| HB0034 | Active comparator | Subjects will be given a single intravenous infusion of HB0034 on D1. Receives: Drug: HB0034 |
| Placebo | Placebo comparator | Subjects will be given a single intravenous infusion of placebo on D1. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieved GPPGA pustulation subscore of 0/1 (no/almost no visiable pustules) at Week 1.
Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)
Measured: Week 1
Secondary outcomes (2)
Percent (%) improvement from baseline in GPPASI at Week 1
Generalized Pustular Psoriasis Area and Severity Index (GPPASI)
Measured: Week 1
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: 12-20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start29 Feb 2024
- Primary completion13 Feb 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular Psoriasis (GPP)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231381
- Sponsor's protocol ID
- HB0034-04
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2024
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Double-blind, Randomized, Placebo Parallel-controlled Trial to Evaluate the Efficacy and Safety of HB0034 in Patients with GPP Presenting with an Acute Flare of Moderate to Severe Intensity
- ClinicalTrials.gov ID
- NCT06231381
- Acronym / sponsor ID
- HB0034-04
- Conditions
- Generalized Pustular Psoriasis (GPP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Jan 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 II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
Detailed description
GPP patients who are experiencing an acute flare will be screened. Before randomization, the investigator must ensure that the subjects meet all inclusion criteria and do not meet any exclusion criteria.
Subjects will be given a single intravenous infusion of HB0034 or placebo (2:1) on D1 and be hospitalized for at least 8 days after administration of the study drug (including Day 1 for administration). Thereafter, the decision of the patient's discharge will be left at the discretion of the investigator and based on the evolution of the GPP flare and the patient's health status.
Subjects will be followed up to W12-W20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB0034 | Active comparator | Drug: HB0034Subjects will be given a single intravenous infusion of HB0034 on D1. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will be given a single intravenous infusion of placebo on D1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be experiencing an acute GPP flare of moderate-to-severe intensity at baseline, defined as:
- 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 (12 listed)
- Drug-triggered acute generalized exanthematous pustulosis (AGEP);
- Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO);
- Other active inflammatory or autoimmune diseases requiring systemic treatment with immunosuppressants, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), inflammatory bowel disease, and uveitis.
- Patients with an increased risk of infectious complications as assessed by the investigator (e.g., a recent suppurative infection, any congenital or acquired immunodeficiency, such as HIV infection, prior organ or stem cell transplantation);
- Patients who have received a live vaccine or investigational live vaccine within 6 weeks prior to the first dose of the study drug, or plan to receive a live vaccine or participate in a clinical study of investigational live vaccine during the study period or within 6 weeks after completion of administration of the study drug;
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: Recombinant Humanized anti-IL-36R Monoclonal antibodyAnti-IL-36R antibody | Drug | HB0034 |
| Placebonon-biologically active drug | Other | Placebo |
Primary outcome
Proportion of subjects who achieved GPPGA pustulation subscore of 0/1 (no/almost no visiable pustules) at Week 1.
Time frame: Week 1
Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)
2 secondary outcomes
Percent (%) improvement from baseline in GPPASI at Week 1
Time frame: Week 1
Safety endpoints include the proportion of subjects with TEAEs.
Time frame: 12-20 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- 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.
2 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 HB0034 in people with Generalized Pustular Psoriasis (GPP), run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of subjects who achieved GPPGA pustulation subscore of 0/1 (no/almost no visiable pustules) at Week 1. (time frame: Week 1). 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 19 Mar 2025.