Decreasing Resident Memory T Cells While Increasing Clinical Durability: Higher Induction Doses of Risankizumab for Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52
研究概览
简要总结
This pilot study explores higher than standard doses of risankizumab for plaque psoriasis, to see effects on resident memory T cells and skin clearance.
详细描述
This is a pilot study that explores whether higher initial doses of risankizumab (300 mg and 600 mg, 2 times and 4 times the standard initial doses for plaque psoriasis) can more effectively target resident memory T cells, a type of immune cell within psoriatic lesions, and whether this results in higher levels of completely clear skin and for longer periods of time following withdrawal of drug. It is believed that resident memory T cells in psoriatic skin contribute to the persistence of psoriasis. It is believed that if the study drug can more effectively eliminate these cells, better clearance of psoriasis may be achieved (when compared to standard initial doses of study drug).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subject has provided written consent
- •Subject has the ability to comply with all study visits and procedures
- •Subject is at least 18 years of age
- •Subject has chronic stable plaque psoriasis for at least 6 months and with a severity of BSA greater than or equal to 10 and PASI greater than or equal to 12
- •Female subjects of child-bearing potential must have a negative urine test at screening and baseline. Female subjects must be either postmenopausal, or permanently surgically sterile, or for women of child-bearing potential practicing at least one form of birth control
排除标准
- •Breastfeeding or pregnant women, or women who plan to become pregnant during study period
- •Participation in any other clinical trial
- •Active infection with HIV, hepatitis B virus, or hepatitis C virus
- •Active infection with tuberculosis or untreated latent tuberculosis
- •History of known active cancer, other than non-melanoma skin cancer or cervical carcinoma in situ, in the past 3 years
- •History of drug or alcohol abuse in the past 6 months, as per investigator's assessment
- •History of suicidal ideation or attempts in the past 6 months
- •Presence of any concurrent illness, which in the opinion of the investigator, would place the patient at unnecessary safety risk during the trial or interfere with completion of the trial
- •Treatment with topical medications for psoriasis in the past 2 weeks
- •Treatment with oral medications for psoriasis in the past 4 weeks
- •Phototherapy for psoriasis in the past 4 weeks
- •Any prior treatment with Risankizumab
- •Treatment with biologic medications for psoriasis (other than Risankizumab) in the past 4 months
研究组 & 干预措施
risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16
干预措施: risankizumab (Drug)
risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16
干预措施: risankizumab (Drug)
结局指标
主要结局
CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52
时间窗: 52 weeks
The number of lesional CD8+ Trm1 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm1 cells were identified as IFNγ+/CD8+/CD69+ T cells.
CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52
时间窗: 52 weeks
The number of lesional CD8+ Trm17 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm17 cells were identified as IFNγ+/CD8+/CD69+ T cells.
次要结局
- PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab.(Enrollment to Week 52)
- Safety Events(Enrollment to Week 52)