NCT06779097尚未招募4 期
A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Converted From Other Biologics
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,564
- 试验地点
- 1
- 主要终点
- The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90).
研究概览
简要总结
This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old at the time of signing the informed consent, regardless of gender;
- •Diagnosed with moderate to severe plaque psoriasis;
- •The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- •Patients who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the Chinese Guidelines for the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy.
排除标准
- •Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
- •Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
- •Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
- •Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after the last receipt of the study drug;
- •Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
- •Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
研究组 & 干预措施
Vunakizumab (IL-17A inhibitor)
Experimental
干预措施: Vunakizumab (IL-17A inhibitor) (Drug)
结局指标
主要结局
The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90).
时间窗: Three months
Proportion of subjects achieving sPGA 0/1 response at week 12.
时间窗: Three months
次要结局
- Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52.(One month， Three months，Twelve months)
- The time when subjects reached PASI 75 and PASI 90 within 12 weeks(Three months)
- The time when subjects reached PASI 75, PASI 90, PASI 100 within 52 weeks.(Twelve months)
- Changes in PASI scores relative to baseline at each visit during 52 weeks.(Twelve months)
- Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.(One month， Three months， Six months，Twelve months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque PsoriasisModerate to Severe Plaque PsoriasisNCT06696417First Hospital of China Medical University1,516
已完成
4 期
A clinical study to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation in patients with Chronic Obstructive Pulmonary DiseaseCTRI/2023/03/050717Zydus Healthcare Limited200
尚未招募
4 期
A prospective, single-arm, multi-center phase IV clinical research to evaluate the safety of Jinhua Qinggan Granules in the treatment of influenzaInfluenzaITMCTR2100005166Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
已完成
4 期
Safety and Efficacy of Amantadine Tablets for the Treatment of Parkinsons Disease (A disorder of the central nervous system that affects movement, often including tremors) and Drug-induced Extrapyramidal Reactions (involuntary or uncontrollable movements, tremors, muscle contractions) in PatientsCTRI/2023/04/051973Sun Pharma Laboratories Limited (SPLL)163
尚未招募
4 期
Safety and efficacy of Brinzolamide and Timolol eye drops to decrease intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension for whom single drug therapy provides insufficient for intraocular pressure reductioCTRI/2023/05/052720Sun Pharma Laboratories Limited (SPLL)