HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

NCT05512598 | Completed Phase 1

• 1 other identifier: HB0034-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).

Conditions

Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  90 days

Secondary Outcomes (3)

• Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)

  12 weeks

• Cmax

  12 weeks

• AUC0-infinity

  12 weeks

Study Arms (1)

HB0034

EXPERIMENTAL

Recombinant Humanized Anti-IL-36R Monoclonal antibody

Drug: HB0034

Interventions

HB0034 DRUG

HB0034, a single dose

Also known as: HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody

HB0034

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Huaota Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Dermatology Hospital of Shandong First Medical University

Shandong, Shandong, 250000, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhang Furen, Doc.

  Shandong Provincial Dermatology Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: November 6, 2022
• Primary Completion: November 15, 2023
• Study Completion: January 10, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)