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Tests treatment safety and results for Generalized Pustular Psoriasis (GPP)
Official title Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)
ClinicalTrials.gov ID: NCT06231381
What this study is testing
What is HB0034?
HB0034 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for generalized pustular psoriasis (gpp).
Also referred to as Recombinant Humanized anti-IL-36R Monoclonal antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- Patients with an increased risk of infectious complications as assessed by the investigator (e.g., a recent suppurative infection, any congenital or...
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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...
- 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;
- 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...
- people who are pregnant or breastfeeding, or those who have a positive pregnancy test result. Breastfeeding female people who stop breastfeeding prior to the first dose of the study drug until 16 weeks after the end of...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.