NCT07280702招募中4 期
Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks
研究概览
简要总结
The purpose of this research study is to determine the effectiveness of adding deucravacitinib to the participant's current Psoriatic Arthritis (PsA) treatment to see if it improves their symptoms and quality of life.
This study is exploring a new treatment approach that may help improve control of psoriatic disease by targeting different parts of the disease process. By combining therapies that work together, the goal is to offer better symptom relief with fewer or more manageable side effects than some current treatments.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 with confirmed psoriatic arthritis based on CASPAR criteria.
- •Ability to provide informed consent and comply with study procedures.
- •Patients with plaque psoriasis BSA>3% OR PsA with [SJC>2 AND TJC >3] despite stable background anti-TNF therapy for at least 6 months, with or without csDMARDs (i.e MTX, leflunomide, sulfasalazine, hydroxychloroquine).
- •Concurrent use of 1 csDMARD, and/or NSAID, and/or oral glucocorticoid is permitted but not required during the study. If such treatment was administered, then participants must meet the following requirements:
- •If on csDMARD (methotrexate [MTX], sulfasalazine [SSZ], leflunomide [LEF], hydroxychloroquine [HCQ]), the participant must have been on it for at least 12 weeks and be on a stable dose for at least 28 days prior to Day
- •If on MTX, the route of administration and dose must be stable and the dose must be ≤ 25 mg/week.
- •If on SSZ, the dose must be ≤ 3 g/day.
- •If on HCQ, the dose must be ≤ 400 mg/day.
- •If on LEF, the dose must be ≤ 20 mg/day. Note: If currently not on MTX, SSZ, or HCQ, the participant must not have received it for at least 28 days prior to Day
- •If currently not on LEF, the participant must not have received it for at least 12 weeks prior to Day
- •If on an NSAID, the participant must be on a stable dose for at least 14 days prior to Day
- •Stable background use of prednisone 15 mg daily or equivalent is permitted. If on oral glucocorticoids, the participant must be on a stable dose of ≤ 15 mg/day prednisone equivalent for at least 28 days prior to Day
- •Note: If currently not on oral glucocorticoids, the participant must not have received oral glucocorticoids within 28 days prior to Day 1
排除标准
- •History of failure of more than two anti-TNF therapies, prior history of failure of TYK2 and JAK inhibitors.
- •History of prior allergic reaction or intolerance to deucravacitinib.
- •History of primary failure of anti-IL17, anti-IL23 is excluded. Note that prior exposure to these agents is allowed for reasons other than primary failure, eg intolerance, insurance / access issues, etc).
- •Systemic agents other than anti-TNF or csDMARD (ie. MTX, leflunomide, sulfasalazine, hydroxychloroquine) must have ceased > 6 months prior to baseline.
- •Doses or glucocorticoids >15mg daily prednisone or equivalent.
- •Severe cardiovascular, hepatic, or renal impairment.
- •History or evidence of outpatient active infection and/or febrile illness within 14 days prior to Day
- •History of serious bacterial, fungal, or viral infection requiring hospitalization or parenteral antimicrobial treatment (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 60 days prior to Day
- •Receipt of any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria) at screening.
- •Recent herpes zoster or herpes simplex infection or history of serious herpes zoster or herpes simplex infection defined as:
- •a) Herpes zoster or herpes simplex lesions within 30 days prior to randomization, OR
- •b) History of serious herpes zoster or serious herpes simplex infection, which includes, but it is not limited to, any episode of disseminated herpes simplex, multi- dermatomal herpes zoster, herpes encephalitis, ophthalmologic herpes, and/or recurrent herpes zoster (recurrent herpes zoster is defined as more than 2 episodes in the last 2 years).
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of opportunistic infections [eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis], history of splenectomy, primary immunodeficiency).
- •Receipt of any live vaccine within 60 days prior to Day 1 or plans to receive a live vaccine during the study or within 60 days after completing study treatment.
- •Evidence of, or positive testing for, hepatitis B virus or hepatitis C virus at screening.
- •Positive testing for human immunodeficiency virus 1 or 2 by antibody testing at screening.
- •History of active TB prior to the screening visit, signs or symptoms of active TB at screening, positive QuantiFERON®-TB Gold (or equivalent) test result or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) test results at screening.
- •History of chronic or recurrent infectious disease.
- •History of VTE, MACE, active solid malignancy or history of malignancy <5 years, any hematologic malignancy; history of multiple serious infections requiring hospitalization in the past 5 years, history of opportunistic infection, any condition which in the opinion of the investigator would pose a safety risk or inability to assess key endpoints in the study.
- •History of fibromyalgia/central sensitization, or other joint disease which in the opinion of the investigator would make musculoskeletal disease activity assessment challenging in the context of this study.
- •History of other inflammatory dermatosis which in the opinion of the investigator would make skin disease activity assessment challenging in the context of this study (eg atopic, contact dermatitis, etc).
- •Exclude use of topicals except for mild to mid-potency topical steroids for use only in cosmetically sensitive areas such as the face.
研究组 & 干预措施
established standard of care anti-TNF plus placebo
Placebo Comparator
Placebo will be administered in tablet form. Anti-TNF will be administered by injection.
干预措施: Placebo (Drug)
established standard of care anti-TNF plus deucravacitinib
Experimental
Deucravacitinib will be administered in tablet form. Anti-TNF will be administered by injection.
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks
时间窗: 24 weeks
Proportion of patients achieving a novel composite endpoint of BSA \</= 1 AND SJC \</= 1) OR (BSA \</= 1 AND TJC \</= 1) at 24 weeks
次要结局
- Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.(baseline and weeks 5, 12, 24, and 48)
- Percentage achieving BSA < 1% (NPF definition) BL at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
- Resolution of Spondyloarthritis Research Consortium of Canada at baseline and at weeks 24 and 48(baseline and weeks 24 and 48)
- Resolution of Leeds Enthesitis Index at baseline and at weeks 24 and 48(baseline and weeks 24 and 48)
- Change from baseline Health Assessment Questionnaire - Disability Index at weeks 24 and 48(baseline and weeks 24 and 48)
- Change from baseline Pruritis Numeric Rating Scale at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
- Change from baseline Joint pain Visual Analog Scale at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
- Change from baseline patient global assessment of arthritis at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
- Change from baseline Dermatology Life Quality Index at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
- Proportion of patients achieving Minimal Disease Activity (5/7 criteria) at weeks 24 and 48(weeks 24 and 48)
- Proportion of patients achieving Very Low Disease Activity (7/7 criteria) at weeks 24 and 48(weeks 24 and 48)
- Proportion of patients achieving Minimal Disease Activity - Skin (MDA with skin domain met) at weeks 24 and 48(weeks 24 and 48)
- Percentage achieving Psoriatic Area and Severity Index 75/90/100, PASI < 1 BL at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
- Change from baseline Psoriatic Arthritis Impact of Disease 12-item Questionnaire and proportion achieving Patient Acceptable Symptom State cutoff at weeks 12, 24 and 48(baseline and weeks 12, 24 and 48)
研究者
Joseph Merola
Professor & Chair-Dermatology
University of Texas Southwestern Medical Center
研究点 (2)
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