2022-502991-21-00招募中2 期
Proof of concept study (multicenter, phase II) on the efficacy of the selective TYK2 inhibitor Deucravacitinib in Lichen planus patients (DEUCRALIP)
Rheinische Friedrich Wilhelms Universitaet Bonn4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change in the objective clinical symptoms (measured with the Lichen Planus Activity and Damage Index(LiPADI) Activity Score, from baseline (V1, day 1) to EOS (V4, day 112)
研究概览
简要总结
Evaluation of the efficacy of deucravacitinib on objective clinical symptoms/ disease activity in lichen planus patients
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Open-label phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects male or female, aged ≥18 years
- •The subject has given written informed consent to participate in the trial
- •Subjects with histologically proven and symptomatic lichen planus
- •Ability to follow study instructions and willingness to attend and complete all required visits
- •LiPADI Acivity Score ≥ 6 or ≥ 3 in patients with mucosal involvement only
排除标准
- •Subjects without legal capacity are unable to understand the nature, scope, significance and consequences of this clinical trial
- •Subjects with a history of a primary immunodeficiency
- •Subjects with severe hepatic impairment (Child-Pugh C)
- •Subjects who neither received a COVID-vaccination following EU regulations nor experienced a COVID-19 infection
- •Subjects who will need to receive a COVID-vaccination with an mRNA vaccine during the double-blind phase of the study
- •Subjects who will need to receive routine-vaccination during the study period (Comment: Lichen planus is an IFN-mediated inflammatory disease which is prone to worsen after application of vaccines, due to their IFN-stimulating effects)
- •Subjects with clinically significant abnormal laboratory value in the opinion of the investigator
- •Subjects treated within the last 8 weeks before baseline/day 1 with oral deucravacitinib or any other systemic JAK/TYK-specific inhibitor
- •Subjects treated within the last 8 weeks before baseline/day 1 with any systemic immunosuppressive/ immunomodulatory agent, other than SOC-medications (for SOC-medications see chapter 10.15.3.)
- •Patient treated within the last 12 weeks before baseline/day 1 with any systemic retinoid
- •Subjects treated topically within the last 4 weeks before baseline/day 1 with a topical class III or class IV steroid (as shown in Figure 3) and/ or other topical immunosuppressive agents, other than SOC-medications (for SOC-medications see chapter 10.15.3.)
- •Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
- •Women who are currently pregnant (positive pregnancy test, e.g. β-hCG test in urine/serum) or lactating women
- •Women with a planned pregnancy within the study period and 16 weeks thereafter
- •Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration and 16 weeks thereafter (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- •Reported history (within the last 12 months before screening) or persistent abuse of medication, drugs or alcohol in the assessment of the medical practitioner investigator, considering safety and trial and medication adherence of the participant
- •Known allergy/ incompatibility against deucravacitinib
- •Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product (except for DEUCRALIP/deucravacitinib for lichen planus), up to 120 days prior to participation in that clinical trial
- •Subjects with a history of malignant neoplasm within the last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years
- •Chronic or acute infectious disease (including but not limited to HIV, Hepatitis B or C infection, Tbc or latent Tbc infection), disease predisposing for infectious disease or recurring infectious diseases in the history
- •Hospitalization for treatment of infection within 60 days prior to Day 1
- •History of serious herpes zoster or serious herpes simplex infection, which includes, but is not limited to, any episode of disseminated herpes simplex, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (recurrent is defined as 2 episodes within 2 years)
结局指标
主要结局
Change in the objective clinical symptoms (measured with the Lichen Planus Activity and Damage Index(LiPADI) Activity Score, from baseline (V1, day 1) to EOS (V4, day 112)
Change in the objective clinical symptoms (measured with the Lichen Planus Activity and Damage Index(LiPADI) Activity Score, from baseline (V1, day 1) to EOS (V4, day 112)
次要结局
- Change of DLQI from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms
- Change in the LiPADI Activity Score from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3 and OLE-V3 in both arms
- Differences in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1, EOS/V4, OLE-V3) between placebo and treatment arm
- Change in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1 vs EOS/V4 vs OLE-V3) in both arms
- Change of DLQI from baseline (V1) to EOS (V4) between placebo and treatment arm
- Change of Itch NRS from baseline (V1) to EOS (V4) between placebo and treatment arm
- Change of Itch NRS from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms
- Change in the amount of steroids used from baseline (V1) to EOS (V4) between placebo and treatment arm
研究者
Jörg Wenzel
Scientific
Rheinische Friedrich Wilhelms Universitaet Bonn
研究点 (4)
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