A Phase 3b, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Moderate-to-severe Non-pustular Palmoplantar Psoriasis (PPPsO)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Part 1: Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) 0 or 1 ("Clear" or "Almost Clear") With at least a 2-point Reduction From Baseline at Week 16
研究概览
简要总结
Palmoplantar psoriasis (PPPsO) is a type of psoriasis that affects the palms of hands and soles of the feet. It can cause red, thick, scaly patches, and it is often associated with pain and itching. These symptoms can make daily life hard and can have a bigger effect on quality of life than psoriasis in some other areas of the body.
Treatment can also be difficult because the skin on the palms and soles is thick, so treatments put on the skin (topical treatments) may not work as well.
The main aim of this study is to find out how well zasocitinib works in reducing the skin redness, thickening, scaling, as well as fissures (narrow, elongated tears) on palms and soles of adults. Other aims are to learn if zasocitinib reduces the surface area of psoriasis on the palms and soles in adults with mainly Palmoplantar psoriasis.
The study is conducted in 2 parts with a possibility of continued treatment (long-term extension). In Part 1, participants will receive zasocitinib for 4 months (16 weeks). Participants who finish Part 1 may be able to continue to Part 2 if the study doctor thinks they would benefit. Participants who continue to Part 2, will keep taking zasocitinib until they have been treated for about 1 year (52 weeks). After that, participants may choose to keep taking zasocitinib for another year (52 weeks). Participants will be followed for about 1 month (4 weeks) after the end of treatment.
During the study, participants will visit their study clinic 16 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 Willingness:
- •The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
- •The participant has provided informed consent and any required privacy authorization before the initiation of any trial procedures.
- •Disease Characteristics:
- •The participant has a diagnosis of chronic non-pustular palmoplantar psoriasis for greater than or equal to (>=) 6 months prior to the screening visit.
- •Participant has moderate-to-severe palmoplantar psoriasis, as defined by a ppIGA score >=3 at screening and Day 1 (Baseline).
- •At screening and Day 1 (Baseline), the participant meets all of the following criteria:
- •Moderate-to-severe plaque psoriasis as defined by an sPGA >=3
- •Moderate-to-severe palmoplantar psoriasis, as defined by a PPASI >=8
- •Plaque psoriasis BSA involvement of >=0.25 percent (%) and up to 10%, excluding the palms and soles
- •Participant must be a candidate for phototherapy or systemic therapy.
- •Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.
- •Age and Reproductive Status:
- •Participant is aged 18 years or older at the time of consent.
- •Participant meets the following birth control requirement: An individual with potential for pregnancy who is now surgically sterile; or a participant of nonchildbearing potential with laboratory confirmation of postmenopausal status; or, if sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the time of signing of the informed consent throughout the duration of the trial and for at least 10 days after the last study dose of trial intervention. The use of effective contraception will be required for assigned male sex at birth participants.
排除标准
- •Target Disease-Related Exclusions:
- •Participant has evidence of nonplaque PsO (pustular PsO, palmoplantar pustulosis, acrodermatitis continua of Hallopeau, erythrodermic, or guttate PsO) or presence of pustules.
- •Participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- •Prohibited Psoriasis Treatments Exclusions:
- •For the below prohibited psoriasis treatments, the washout period prior to Day 1 must be 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/
- •Antibodies to IL-
- •There will be an allowance for up to 10 percent (%) of participants with previous IL-23 exposure to enroll. A washout period of 6 months prior to day 1 is required.
- •Previous exposure to Janus Kinase (JAK) inhibitors.
- •Previous exposure to Tyrosine Kinase 2 (TYK2) inhibitors.
- •Recent/Concurrent Infections Disease Exclusions:
- •History of active tuberculosis (TB), signs or symptoms of active TB. Evidence of latent TB infection, active Herpes infection at screening, history of serious herpetic infection or recurrent herpes zoster, evidence of Hepatitis C virus (HCV), evidence of Hepatitis B Virus (HBV) or HIV-positive status.
- •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/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 significant/uncontrolled psychiatric illness, in the opinion of the investigator.
- •Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts.
- •Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1
- •Allergies and Adverse Drug Reactions Exclusions:
- •Participant has history of significant drug allergy (such as anaphylaxis).
- •Participant has a known or suspected allergy to zasocitinib or any of their components.
研究组 & 干预措施
Part 1: Zasocitinib 30 mg
Participants will receive zasocitinib 30 milligrams (mg), orally, once daily (QD) from Day 1 through Week 16. Participants who complete 16 weeks treatment will be eligible to continue into Part 2 and those who do not enter Part 2, will enter a 4-week safety follow-up period.
干预措施: Zasocitinib (Drug)
Part 2: Zasocitinib 30 mg
Eligible participants who continue from Part 1 to Part 2 (if determined by principal investigator [PI]) will receive zasocitinib 30 mg, orally, QD from Week 16 through Week 52, followed by a 4-week safety follow-up period.
干预措施: Zasocitinib (Drug)
Optional Long-Term Extension (LTE): Zasocitinib
Participants who are receiving zasocitinib and complete Week 52, will have the option to continue to receive uninterrupted zasocitinib therapy for up to an additional 52 weeks or until it becomes commercially available, whichever comes first.
干预措施: Zasocitinib (Drug)
结局指标
主要结局
Part 1: Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) 0 or 1 ("Clear" or "Almost Clear") With at least a 2-point Reduction From Baseline at Week 16
时间窗: At Week 16
The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), scaling and fissures of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."
次要结局
- Part 1: Percentage of Participants Achieving >=75%, >=90% and 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI-75, PPASI-90 and PPASI-100) at Week 16(At Week 16)
- Part 1: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) 0 or 1 ("Clear" or "Almost Clear") With at Least a 2-point Reduction From Baseline at Week 16(At Week 16)
- Part 1: Percentage of Participants Achieving an sPGA 0 at Week 16(At Week 16)
- Part 2: Percentage of Participants Achieving ppIGA 0 From Baseline to Week 52(Baseline up to Week 52)
- Part 1: Percentage of Participants With at Least a 3-point Reduction From Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16, Among Participants With a Baseline Skin Pain-NRS >=3(At Week 16)
- Part 1: Percentage of Participants who Achieve a Score of 0 or 1 in Itch NRS at Week 16(At Week 16)
- Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Percentage of Participants Achieving sPGA 0 or 1 ("Clear" or "Almost Clear") From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Percentage of Participants Achieving sPGA 0 or 1 ("Clear" or "Almost Clear") From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Percentage of Participants Achieving sPGA of 0 From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Percentage of Participants Achieving sPGA of 0 From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Percentage of Participants Achieving ppIGA 0 From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Percentage of Participants With at Least a 3-point Reduction in Skin Pain-NRS From Baseline to Week 52, Among Participants With a Baseline Skin Pain-NRS >=3(Baseline up to Week 52)
- Part 2: Percentage of Participants With at Least a 3-point Reduction in Skin Pain-NRS From Week 16 to Week 52, Among Participants With a Baseline Skin Pain-NRS >=3(Week 16 up to Week 52)
- Part 2: Percentage of Participants With at Least a 4-point Reduction in Skin Pain-NRS From Baseline to Week 52, Among Participants With a Baseline Skin Pain-NRS >=4(Baseline up to Week 52)
- Part 2: Percentage of Participants With at Least a 4-point Reduction in Skin Pain-NRS From Week 16 to Week 52, Among Participants With a Baseline Skin Pain-NRS >=4(Week 16 up to Week 52)
- Part 2: Percentage of Participants who Achieve an Itch NRS of 0 at Week 52(At Week 52)
- Part 2: Change in Itch NRS From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Change in Itch NRS From Week 16 to Week 52(Week 16 up to Week 52)
- Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Values(From Baseline up to follow up (up to 108 weeks))
- Part 2: Percentage of Participants With a Change in the Psoriasis Symptom Scale (PSS) From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Percentage of Participants With a Change in the PSS From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Change in Palmoplantar Quality of Life Instrument (PPQLI) From Baseline to Week 52(Baseline up to Week 52)
- Part 2: Change in PPQLI From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Change in DLQI From Week 16 to Week 52(Week 16 up to Week 52)
- Part 2: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 52(At Week 52)
- Parts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs) and Serious Adverse Events (SAEs)(From screening up to follow up (up to 108 weeks))
- Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Values(From screening up to follow up (up to 108 weeks))
- Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values(From Baseline up to follow up (up to 108 weeks))