Phase 2 Psoriasis Trial, Recruiting NCT06231381 Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. Condition: Psoriasis
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Phase 2 Psoriasis Trial, Recruiting

NCT06231381
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are currently experiencing a moderate-to-severe flare of Generalized Pustular Psoriasis (GPP), meaning their condition scores 3 or higher on a standard doctor-rated scale, new or worsening pustules are present with a pustule-specific score of 2 or higher, and at least 5% of their body surface is covered with pustules
  • Men and women of reproductive age who have no plans to have children, and who are willing to use reliable contraception throughout the study and for 6 months after the last dose of the study drug
  • People who fully understand and voluntarily sign a consent form, and who are willing and able to attend all scheduled study visits

Who may not be able to join:

  • People whose pustular skin condition was triggered by a drug reaction (a condition called AGEP)
  • People who have a condition known as SAPHO syndrome (a disorder involving joints, skin, and bones)
  • People who have another active inflammatory or autoimmune disease — such as rheumatoid arthritis, psoriatic arthritis, lupus, inflammatory bowel disease, or uveitis — that requires treatment with immune-suppressing medications
  • People who the study doctor believes are at higher risk of serious infections, such as those with a recent severe infection, a weakened immune system, HIV, or a history of organ or stem cell transplant
  • People who have received a live vaccine within 6 weeks before the first study dose, or who plan to receive a live vaccine during the study or within 6 weeks after the final dose
  • People who have had a serious injury or major surgery within 1 month before the first study dose, or who plan to have elective surgery during the study period
  • People who currently have, are suspected of having, or have had cancer within the past 5 years
  • People with a history of severe allergic reactions (grade 3–4) to other monoclonal antibody treatments, or who are known to be allergic to protein-based drugs, recombinant proteins, or any ingredient in the study drug (HB0034)
  • People who are pregnant, breastfeeding, or have a positive pregnancy test — though women who stop breastfeeding before the first dose and remain breastfeeding-free until 16 weeks after the trial ends would not be excluded on this basis (confirm with trial site)
  • People who are currently in another clinical trial, or who have participated in a clinical trial of any drug or device within the past 30 days — or within 5 half-lives of that drug, whichever is the longer period
  • People who are unlikely to follow the study requirements, such as attending follow-up visits reliably and completing the full study
  • People whom the study doctor considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 13636638684

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
29 February 2024
Est. completion
13 February 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of subjects who achieved GPPGA pustulation subscore of 0/1 (no/almost no visiable pustules) at Week 1.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov