Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of TQH2929 Injection in Patients With Acute Exacerbations of Generalized Pustular Psoriasis
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-03-24
36
Participants Needed
32
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis, a severe skin condition. This multicenter, randomized, double-blind, placebo-controlled phase II clinical trial aims to enroll 36 participants to compare the investigational drug against a placebo. Participants receive a single intravenous infusion of either TQH2929, a humanized monoclonal antibody that interferes with the diseases signal pathways, or a placebo that contains no active ingredients. The study design includes careful monitoring of treatment effects and side effects, conducted in a blinded manner with both participants and investigators unaware of group assignments. During the study, participants will undergo assessments to measure skin symptoms and disease severity using various scales at one and four weeks after treatment. Researchers will also monitor drug levels, immune responses, and any adverse events over several months. The total participation time includes follow-up visits to ensure safety and evaluate longer-term outcomes.
CONDITIONS
Brief Title
A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old at screening, any gender
- Diagnosed with generalized pustular psoriasis according to 2017 ERASPEN consensus
- Experiencing an acute flare-up of generalized pustular psoriasis
- Able to read, understand, and sign informed consent
- Willing and able to comply with study visits and procedures
- Women of childbearing potential must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Pustules limited to psoriasis vulgaris plaques
- Skin or medical conditions interfering with treatment evaluation
- Severe, progressive, or uncontrolled diseases judged unsuitable by investigator
- Serum virological abnormalities at screening
- Active tuberculosis or recent contact with tuberculosis cases, or positive IGRA test
- Serious infection requiring hospitalization within 2 months before baseline
- Active infection needing systemic antibiotics, antifungals, or antivirals within 2 weeks before baseline
- History of opportunistic infection within 6 months before baseline
- Live vaccine received within 12 weeks before baseline
- Major surgery within 4 weeks before baseline or planned during study
- Blood transfusion within 4 weeks before baseline
- Participation in other drug or device trials within 4 weeks before baseline
- Known or suspected immunodeficiency
- Active or history of any malignancy
- Alcohol, drug, or known drug dependence
- Pregnant or breastfeeding
- Unable to tolerate intravenous infusion administration
Research Team
H
Hang Li, Doctor
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