Generalized Pustular PsoriasisPhase 1NCT05512598
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
A Phase 1 study testing HB0034 in people with Generalized Pustular Psoriasis, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2022to 10 Jan 2024
- Phase
- Phase 1
- 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 patients, aged 18 to 75 years at screening
- A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria
- Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
- Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires.
Who cannot join
- Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress
- History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia)
- Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
- Ongoing use of prohibited psoriasis treatments
- Further exclusions criteria apply
Trial locations and contacts
1 site in 1 country.
China1 site
Dermatology Hospital of Shandong First Medical University
Shandong, Shandong, 250000
About this study
Official title: Multi-centre, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of HB0034 in Patients Acute Generalized Pustular Psoriasis (GPP) Flare
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
Read the detailed description
This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.
- 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 HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034, a single dose
| Study group | Role | What they receive |
|---|---|---|
| HB0034 | Experimental | Recombinant Humanized Anti-IL-36R Monoclonal antibody Receives: Drug: HB0034 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with drug related adverse events
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
Measured: 90 days
Secondary outcomes (3)
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)
efficacy outcome of investigational drug
Measured: 12 weeks
Cmax
The maximum measured concentration of the analysis in plasma
Measured: 12 weeks
AUC0-infinity
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start6 Nov 2022
- Primary completion15 Nov 2023
- Study completion10 Jan 2024
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Furen, Doc., Principal investigator, Shandong Provincial Dermatology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512598
- Sponsor's protocol ID
- HB0034-02
- Status last verified
- Jan 2024
- First submitted
- 22 Aug 2022
- Last updated
- 23 Jan 2024
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of HB0034 in Patients Acute Generalized Pustular Psoriasis (GPP) Flare
- ClinicalTrials.gov ID
- NCT05512598
- Acronym / sponsor ID
- HB0034-02
- Conditions
- Generalized Pustular Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 23 Aug 2022 (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 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
Detailed description
This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.
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: HB0034Recombinant Humanized Anti-IL-36R Monoclonal antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, aged 18 to 75 years at screening
- A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria
- Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
- Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires.
Key exclusion criteria (5 listed)
- Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress
- History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia)
- Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
- Ongoing use of prohibited psoriasis treatments
- Further exclusions criteria apply
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: HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibodyHB0034, a single dose | Drug | HB0034 |
Primary outcome
Number of patients with drug related adverse events
Time frame: 90 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
3 secondary outcomes
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)
Time frame: 12 weeks
Cmax
Time frame: 12 weeks
AUC0-infinity
Time frame: 12 weeks
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 Jan 2024.
- 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.
Zhang Furen, Doc. principal investigator
Shandong Provincial Dermatology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB0034 in people with Generalized Pustular Psoriasis, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site 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 5 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of patients with drug related adverse events (time frame: 90 days). 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 Jan 2024.