A Phase 3 interventional study of Zasocitinib in Palmoplantar Psoriasis, sponsored by Takeda. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Takeda · Phase 3, Interventional, and Treatment
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant Willingness:
The participant has provided and any required privacy authorization before the initiation of any trial procedures.
Disease Characteristics:
At screening and Day 1 (Baseline), the participant meets all of the following criteria:
Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.
Age and Reproductive Status:
Exclusion criteria:
Target Disease-Related Exclusions:
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 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:
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 virus (HCV), evidence of Virus (HBV) or -positive status.
Noninfectious Disorders Exclusions:
Participant has any medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ 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:
Allergies and Adverse Drug Reactions Exclusions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Zasocitinib
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.
Drug: 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.
Drug: Zasocitinib
Zasocitinib oral tablet.
Also known as: TAK-279, NDI-034858
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
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."
Time frame: At Week 16
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
The PPASI is an assessment tool based on the Psoriasis Area and Severity Index (PASI) that assesses induration (thickness), desquamation (scaling), erythema (redness) and surface area affected. Each symptom is evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for both palms and soles, gives a PPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). Higher score indicates more severe disease. PPASI-75, 90 and 100 are defined as participants achieving \>= 75%, \>=90% and 100% improvement from baseline.
Time frame: 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
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.
Time frame: At Week 16
Part 1: Percentage of Participants Achieving an sPGA 0 at Week 16
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.
Time frame: At Week 16
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
The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'. Higher score indicates greater disease severity.
Time frame: At Week 16
Part 1: Percentage of Participants who Achieve a Score of 0 or 1 in Itch NRS at Week 16
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.
Time frame: At Week 16
Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Baseline to Week 52
The PPASI is an assessment tool based on the PASI that assesses induration (thickness), desquamation (scaling), erythema (redness) and surface area affected. Each symptom is evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for both palms and soles, gives a PPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). PPASI-75, 90 and 100 are defined as participants achieving \>=75%, \>=90% and 100% improvement from baseline.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Week 16 to Week 52
The PPASI is an assessment tool based on the Psoriasis Area and Severity Index (PASI) that assesses induration (thickness), desquamation (scaling), erythema (redness) and surface area affected. Each symptom is evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for both palms and soles, gives a PPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).
Time frame: 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
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.
Time frame: 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
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving sPGA of 0 From Baseline to Week 52
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving sPGA of 0 From Week 16 to Week 52
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving ppIGA 0 From Baseline to Week 52
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."
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving ppIGA 0 From Week 16 to Week 52
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."
Time frame: 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
The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.
Time frame: 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
The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.
Time frame: 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
The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.
Time frame: 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
The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants who Achieve an Itch NRS of 0 at Week 52
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.
Time frame: At Week 52
Part 2: Change in Itch NRS From Baseline to Week 52
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.
Time frame: Baseline up to Week 52
Part 2: Change in Itch NRS From Week 16 to Week 52
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants With a Change in the Psoriasis Symptom Scale (PSS) From Baseline to Week 52
The PSS is a participant-reported outcome instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are pain, redness, itching and stinging. Participants rate severity of each symptom using a 5-point scale ranging from 0 (none) to 4 (very severe). Higher score indicates greater disease severity.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants With a Change in the PSS From Week 16 to Week 52
The PSS is a participant-reported outcome instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are pain, redness, itching and stinging. Participants rate severity of each symptom using a 5-point scale ranging from 0 (none) to 4 (very severe). Higher score indicates greater disease severity.
Time frame: Week 16 up to Week 52
Part 2: Change in Palmoplantar Quality of Life Instrument (PPQLI) From Baseline to Week 52
The ppQLI assesses impact on participant quality of life due to palmoplantar psoriasis. Seventeen items evaluate hand functionality, disease symptoms (pain, burning and itch) and social impact due to psoriasis. Fifteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicates more severe disease.
Time frame: Baseline up to Week 52
Part 2: Change in PPQLI From Week 16 to Week 52
The ppQLI assesses impact on participant quality of life due to palmoplantar psoriasis. Seventeen items evaluate hand functionality, disease symptoms (pain, burning and itch) and social impact due to psoriasis. Fifteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicates more severe disease.
Time frame: Week 16 up to Week 52
Part 2: Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 52
The DLQI is a 10-item validated questionnaire completed by participants which is used to assess the impact of skin disease on the participant's quality of life (QoL). The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: Baseline up to Week 52
Part 2: Change in DLQI From Week 16 to Week 52
The DLQI is a 10-item validated questionnaire completed by participants which is used to assess the impact of skin disease on the participant's quality of life (QoL). The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 52
The DLQI is a 10-item validated questionnaire completed by participants which is used to assess the impact of skin disease on the participant's quality of life (QoL). The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: 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)
TEAE: Any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to trial intervention or medicinal product. SAE: Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a suspected transmission of any infectious agent via an authorized medicinal product. An AESI (serious or nonserious) is one of scientific and medical concern specific to the compound or program and includes Infections that are severe or serious or opportunistic, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Time frame: 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
Vital signs will include body temperature, sitting blood pressure (systolic and diastolic) and pulse. Any clinically significant changes in vital signs will be determined at the investigator's discretion.
Time frame: 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
Clinical laboratory parameters will include hematology, serum chemistry, and urinalysis. Any clinically significant changes from baseline in laboratory values will be determined at the investigator's discretion.
Time frame: From Baseline up to follow up (up to 108 weeks)
Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Values
12-lead ECG will be evaluated. Any clinically significant changes from baseline in ECG values will be determined at the investigator's discretion.
Time frame: From Baseline up to follow up (up to 108 weeks)
No study locations are listed for this record.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
Start moved twice since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, last on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zasocitinib