NCT06973291已完成3 期
A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis
Takeda226 个研究点 分布在 3 个国家目标入组 606 人开始时间: 2025年7月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 606
- 试验地点
- 226
- 主要终点
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16
研究概览
简要总结
The main aim of this study is to assess whether zasocitinib works better than deucravacitinib in treating participants with moderate-to-severe plaque psoriasis.
Participants will take one tablet daily of either zasocitinib or a matching placebo, along with one capsule daily of either over-encapsulated deucravacitinib or a matching placebo, for a duration of 16 weeks.
Participants will be in the study for up to 25 weeks, which includes screening period of up to 35 days, a 16-week treatment period, and a 4-week safety follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a diagnosis of chronic plaque psoriasis for >=6 months prior to the screening visit.
- •Participant has stable plaque psoriasis, defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis, for >=6 months before screening.
- •Participant has moderate-to-severe plaque psoriasis, as defined by a PASI score >=12 and an sPGA score >=3, at screening and Day
- •Participant has plaque psoriasis covering >=10 percent (%) of his or her total body surface area (BSA) at screening and Day
- •Participant must be a candidate for phototherapy or systemic therapy.
排除标准
- •- Target Disease-Related Exclusions:
- •Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
- •Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune related disease (for example, inflammatory bowel disease).
- •Participant has a history of excessive sun exposure, has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the trial period. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.
- •Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- •Recent/Concurrent Infectious Disease Exclusions:
- •Tuberculosis (TB):
- •Participant has history of active TB infection, regardless of treatment status.
- •Participant has signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.
- •Participant has evidence of latent TB infection (LTBI) as evidenced by a positive QuantiFERON-TB Gold (QFT) result OR 2 indeterminate QFT results, and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis.
- •Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest computed tomography, Magnetic Resonance Imaging (MRI), or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all participants regardless of QFT results unless the participant has had normal chest imaging in the 6 months prior to screening.
- •Herpes infections:
- •Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day
- •Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
- •Nonherpetic viral diseases:
- •Participant has presence of Hepatitis C Virus (HCV) antibody and a positive confirmatory test result for HCV ribonucleic Acid (RNA) (nucleic acid test or Polymerase Chain Reaction [PCR]).
- •Participant has presence of positive Hepatitis B Surface Antigen (HBsAg+), or indeterminate HBsAg, presence of HBV deoxyribonucleic Acid (DNA) (regardless of serology), or positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (Hepatitis B Core Antibody [HBcAb] positive and Hepatitis B Surface Antibody [HBsAb] negative).
- •Participant has positive results for Human Immunodeficiency Virus (HIV) by serology, regardless of viral load.
- •Other infectious diseases:
- •Participant has a history of active infection or febrile illness within 7 days prior to Day 1, as assessed by the investigator.
- •Participant has history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day
- •Participant has history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1 or oral antimicrobial therapy within 30 days prior to Day
- •Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis).
- •Participant has a history of an infected joint prosthesis, unless that prosthesis has been removed or replaced at least 60 days prior to Day
- •Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
- •Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.
- •Noninfectious Disorders Exclusions:
- •Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/Electrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:
- •Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency, splenectomy.
- •Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.
- •Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
- •Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
- •Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- •For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day
- •Participant has any of the following cardiovascular disease history:
- •A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, nonacute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening.
- •Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
- •Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the trial, in the opinion of the investigator.
- •Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
- •Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day
- •Prohibited Psoriasis Treatments Exclusions:
- •For the below prohibited psoriasis treatments, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition:
- •Participant has received any of the following biologics or biosimilar versions within the time frame indicated:
- •Antibodies to interleukin (IL)-12/-23, IL-17, or IL-23 (for example, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day
- •Tumor Necrosis Factor (TNF) inhibitor(s) (for example, etanercept, adalimumab, infliximab, or certolizumab) within 2 months prior to Day
- •Agents that modulate integrin pathways to impact lymphocyte trafficking (for example, natalizumab) or agents that modulate B cells or T cells (for example, alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day
- •Rituximab or other immune cell-depleting therapy within 6 months prior to Day
- •Participant has used medicated shampoo and/or body wash, including formulations containing but not limited to salicylic acid, corticosteroids, coal tar, vitamin D3 analogues, or other compounds used for the management of psoriasis within 2 weeks prior to Day
- •Participant has used any topical medication that could affect psoriasis presentation (including but not limited to corticosteroids, salicylic acid, urea, alpha- or beta-hydroxy acids, anthralin, retinoids, vitamin D analogues [such as calcipotriol], methoxsalen, trimethylpsoralen, calcineurin inhibitors [for example, tacrolimus], tapinarof, roflumilast, Janus kinase (JAK) inhibitors, or tar) within 2 weeks prior to Day
- •Participant has used any systemic nonbiologic treatment that could affect psoriasis presentation (including oral, intravenous, intramuscular, intra-articular, intrathecal, or intralesional corticosteroids; oral retinoids; immunosuppressive/immunomodulating medication; methotrexate; azathioprine; 6-thioguanidine; mercaptopurine; mycophenolate mofetil; hydroxyurea; cyclosporine; 1,25-dihydroxyvitamin D3 analogues; psoralens; sulfasalazine; fumaric acid derivatives; JAK inhibitors; apremilast) within 4 weeks prior to Day 1, or 5 half-lives, whichever is longer. Note: Intranasal corticosteroids, inhaled corticosteroids, and eye and ear drops containing corticosteroids are permitted.
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研究组 & 干预措施
Deucravacitinib or Placebo
Active Comparator
Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.
干预措施: Placebo to match deucravacitinib (Drug)
Zasocitinib or Placebo
Experimental
Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.
干预措施: Zasocitinib (Drug)
Zasocitinib or Placebo
Experimental
Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.
干预措施: Placebo to match zasocitinib (Drug)
Deucravacitinib or Placebo
Active Comparator
Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16
时间窗: At Week 16
PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (less than or equal to \[\<=\] 3 representing mild disease, greater than or equal to \[\>=3\] to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100 percentage (%) improvement in PASI score relative to baseline PASI score will be reported.
次要结局
- Percentage of Participants Achieving PASI-90 at Weeks 4, 8, 12, and 16(At Weeks 4, 8, 12, and 16)
- Percentage of Participants Achieving PASI <=2 Response at Weeks 4, 8, 12, and 16(At Weeks 4, 8, 12, and 16)
- Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear (0) at Weeks 4, 8, 12, and 16(At Weeks 4, 8, 12, and 16)
- Percentage of Participants Achieving PASI-100 at Weeks 4, 8, and 12(At Weeks 4, 8, and 12)
- Percentage of Participants Achieving PASI-75 at Weeks 4, 8, 12, and 16(At Weeks 4, 8, 12, and 16)
- Percentage of Participants Achieving sPGA of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, and 16(At Weeks 4, 8, 12, and 16)
- Change From Baseline in PASI Score at Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Percent Change From Baseline in PASI score at Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
研究者
研究点 (226)
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