A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
概览
- 阶段
- 3 期
- 干预措施
- Active Comparator
- 疾病 / 适应症
- 未指定
- 发起方
- Takeda
- 入组人数
- 1088
- 试验地点
- 366
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
- 状态
- 招募中
- 最后更新
- 26天前
概览
简要总结
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.
The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
研究者
入排标准
入选标准
- •The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age.
- •Disease Characteristics:
- •The participant has a diagnosis of PsA.
- •The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
- •The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
- •The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
- •The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
- •Medications for PsA:
- •The participant has had at least one of the following:
- •Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR
排除标准
- •PsA and PsO:
- •The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
- •The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
研究组 & 干预措施
Active Comparator Dose C
Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
干预措施: Active Comparator
Placebo + Zasoctinib
Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
干预措施: Placebo
Zasocitinib Dose A
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
干预措施: Zasocitinib
Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
干预措施: Zasocitinib
Placebo + Zasoctinib
Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
干预措施: Zasocitinib
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
时间窗: At Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
次要结局
- Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(At Week 16)
- Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo(At Week 16)
- Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo(At Week 16)
- Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(At Week 16)
- Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A compared to Active Comparator(Baseline, at Week 16)
- Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 4 and 8 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 4 and 8)
- Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving a Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesis Index = 0 through Week 16 for Zasocitinib Dose A and B Compared to Placebo(Baseline up to Week 16)
- Percentage of Participants Achieving ACR20 Response at Week 8 for Zasocitinib Dose A and B Compared to Placebo(At Week 8)
- Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo(Baseline, at Week 16)
- Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo(Baseline, at Week 16)
- Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(At Week 16)
- Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(At Week 16)
- Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(Baseline, at Week 16)
- Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(Baseline, at Week 16)
- Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(Baseline, at Week 16)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator(At Week 16)