ACTIVE_NOT_RECRUITING

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

Conditions

Plaque Psoriasis Latitude Psoriasis 3 Latitude Research Program Latitude PsO OLE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.

Official Title

A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

Quick Facts

Study Start:2024-09-04

Study Completion:2026-05-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06550076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator. * Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures. * Participant is aged 18 years or older at the time of consent. * 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 a sPGA score \>=3 at screening and Day 1. * Participant has plaque psoriasis covering \>=10% of his or her total BSA at screening and Day 1. * Participant must be a candidate for phototherapy or systemic therapy. * Participant has evidence of non-plaque 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 (e.g., inflammatory bowel disease). * Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., 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 study results. These include but are not limited to: 1. 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. 2. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study. 3. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments. 4. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria. 5. 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. 6. 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 1. 7. 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, non-acute cardiac hospitalization (e.g., 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 aortocoronary 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. 8. 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 study, in the opinion of the investigator. 9. Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator. 10. Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator. 11. Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening. 12. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1. * Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer: 1. Antibodies to interleukin (IL) -12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1. 2. Tumor necrosis factor inhibitor(s) (e.g., etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1. 3. Agents that modulate integrin pathways to impact lymphocyte trafficking (e.g., natalizumab) or agents that modulate B cells or T cells (e.g., alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1. 4. Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1. * Participant has any previous exposure to TAK-279 (also known as NDI-034858) or other TYK2 inhibitors, including deucravacitinib, or participant participated in any study that included a TYK2 inhibitor (e.g., deucravacitinib, VTX958, GLPG3667, etc.), unless the participant has documentation of post-trial unblinding that confirms the partcipant did not receive a TYK2 inhibitor. * Participant has a known or suspected allergy to TAK-279 or any of its components. * Participant has completed the parent study or Part A but was permanently discontinued from treatment. * Participant had evidence of significant noncompliance with study visits or study drug in the parent study or Part A, as defined in the parent study protocol or in the opinion of the investigator. * Participant has met criteria for termination from the parent study or Part A, regardless of whether or not the participant was terminated from the parent study or Part A. * Participant has developed evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis) since enrollment in the parent study or Part A. * Participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments. * Participant has received a prohibited psoriasis treatment during the parent study or Part A, whether or not that treatment was documented as a concomitant medication and is expected to continue that treatment.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
* Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures.
* Participant is aged 18 years or older at the time of consent.
* 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 a sPGA score \>=3 at screening and Day 1.
* Participant has plaque psoriasis covering \>=10% of his or her total BSA at screening and Day 1.
* Participant must be a candidate for phototherapy or systemic therapy.
* Participant has evidence of non-plaque 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 (e.g., inflammatory bowel disease).
* Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., 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 study results. These include but are not limited to:
1. 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.
2. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study.
3. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
4. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
5. 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.
6. 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 1.
7. 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, non-acute cardiac hospitalization (e.g., 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 aortocoronary 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.
8. 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 study, in the opinion of the investigator.
9. Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
10. Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator.
11. Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening.
12. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
* Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer:
1. Antibodies to interleukin (IL) -12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1.
2. Tumor necrosis factor inhibitor(s) (e.g., etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1.
3. Agents that modulate integrin pathways to impact lymphocyte trafficking (e.g., natalizumab) or agents that modulate B cells or T cells (e.g., alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1.
4. Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1.
* Participant has any previous exposure to TAK-279 (also known as NDI-034858) or other TYK2 inhibitors, including deucravacitinib, or participant participated in any study that included a TYK2 inhibitor (e.g., deucravacitinib, VTX958, GLPG3667, etc.), unless the participant has documentation of post-trial unblinding that confirms the partcipant did not receive a TYK2 inhibitor.
* Participant has a known or suspected allergy to TAK-279 or any of its components.
* Participant has completed the parent study or Part A but was permanently discontinued from treatment.
* Participant had evidence of significant noncompliance with study visits or study drug in the parent study or Part A, as defined in the parent study protocol or in the opinion of the investigator.
* Participant has met criteria for termination from the parent study or Part A, regardless of whether or not the participant was terminated from the parent study or Part A.
* Participant has developed evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis) since enrollment in the parent study or Part A.
* Participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments.
* Participant has received a prohibited psoriasis treatment during the parent study or Part A, whether or not that treatment was documented as a concomitant medication and is expected to continue that treatment.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Study Director

STUDY_DIRECTOR

Takeda

Study Locations (Sites)

Total Dermatology

Birmingham, Alabama, 35205

United States

University of Alabama Hospital - Whitaker Clinic -

Birmingham, Alabama, 35233-2110

United States

Cahaba Dermatology Skin Health Center

Hoover, Alabama, 35244-2111

United States

Medical Dermatology Specialists

Phoenix, Arizona, 85006

United States

Saguaro Dermatology Associates, LLC - Probity - PPDS

Phoenix, Arizona, 85008-3884

United States

Noble Clinical Research

Tucson, Arizona, 85704

United States

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916-6103

United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913-6475

United States

Zenith Research, Inc.

Beverly Hills, California, 90212

United States

First OC Dermatology Research Inc.

Fountain Valley, California, 92708

United States

Center for Dermatology Clinical Research

Fremont, California, 94538

United States

Long Beach Research Institute

Long Beach, California, 90805

United States

Metropolis Dermatology Downtown LA - Probity - PPDS

Los Angeles, California, 90017-5310

United States

UCLA University of California Los Angeles

Los Angeles, California, 90024

United States

Northridge Clinical Trials

Northridge, California, 91325-4122

United States

UC Davis Dermatology Clinic

Sacramento, California, 95816-3370

United States

TCR Medical Corporation

San Diego, California, 92123-1523

United States

University Clinical Trials

San Diego, California, 92123

United States

Dermatology Institute and Skin Care Center

Santa Monica, California, 90404-2216

United States

UNISON Clinical Trials (Shahram Jacobs md inc.)

Sherman Oaks, California, 91403

United States

Driven Research LLC

Coral Gables, Florida, 33134-3901

United States

Revival Research Corporation - Florida - ClinEdge - PPDS

Doral, Florida, 33122-1902

United States

FXM Clinical Research Ft. Lauderdale, LLC

Fort Lauderdale, Florida, 33308-5211

United States

Direct Helpers Medical Center

Hialeah, Florida, 33012

United States

Florida Academic Centers Research

Miami, Florida, 33136-1003

United States

FXM Clinical Research Miami, LLC

Miami, Florida, 33175-3582

United States

San Marcus Research Clinic Inc

Miami Lakes, Florida, 33014

United States

FXM Research Miramar

Miramar, Florida, 33027-4714

United States

Renstar Medical Research -21 NE 1st Ave

Ocala, Florida, 34470

United States

Lenus Research & Medical Group

Sweetwater, Florida, 33172

United States

Advanced Clinical Research Institute (ACRI) - Florida

Tampa, Florida, 33607-6429

United States

Divine Dermatology and Aesthetics, LLC

Atlanta, Georgia, 30315-2042

United States

Marietta Dermatology & The Skin Cancer Center - Marietta

Marietta, Georgia, 30060-7902

United States

Advanced Medical Research, PC

Sandy Springs, Georgia, 30328

United States

Georgia Skin and Cancer Clinic

Savannah, Georgia, 31419-1768

United States

Leavitt Clinical Research

Idaho Falls, Idaho, 83404-8322

United States

Arlington Dermatology

Rolling Meadows, Illinois, 60008-3811

United States

NorthShore Medical Group Dermatology - Skokie

Skokie, Illinois, 60077-1049

United States

DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location

Clarksville, Indiana, 47129-2201

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

United States

Skin Sciences, PLLC

Louisville, Kentucky, 40217-1444

United States

Dermatology Specialists Research - 3810 Springhurst Blvd

Louisville, Kentucky, 40241-6162

United States

Lawrence J Green, MD LLC

Rockville, Maryland, 20850

United States

University of Michigan Hospital - 1500 E Medical Center Dr

Ann Arbor, Michigan, 48109-5360

United States

Oakland Hills Dermatology - 3400 Auburn Rd

Auburn Hills, Michigan, 48326-3396

United States

Revival Research Corporation - ClinEdge

Troy, Michigan, 48084-3536

United States

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112

United States

Skin Specialists PC

Omaha, Nebraska, 68144

United States

Henderson Clinical Trials

Henderson, Nevada, 89052

United States

Dartmouth Hitchcock Medical Center - Old Etna Rd

Lebanon, New Hampshire, 03766-1937

United States

ALLCUTIS Research, LLC.

Portsmouth, New Hampshire, 03801

United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

United States

Sadick Research Group

New York, New York, 10075-0385

United States

Montefiore AOA - BRANY

The Bronx, New York, 10467

United States

Accellacare of Cary

Cary, North Carolina, 27518

United States

The Skin Surgery Center for Clinical Research - Objective Health - PPDS

Winston-Salem, North Carolina, 27103-7109

United States

Bexley Dermatology Research - Probity - PPDS

Bexley, Ohio, 43209

United States

Wright State Physicians

Fairborn, Ohio, 45324

United States

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124-4005

United States

Oregon Medical Research Center PC

Portland, Oregon, 97201

United States

University of Pittsburgh Medical Center-3601 5th Ave

Pittsburgh, Pennsylvania, 15213-3403

United States

Cumberland Skin Center for Clinical Research - Objective Health - PPDS

Hermitage, Tennessee, 37076-3497

United States

International Clinical Research US LLC

Murfreesboro, Tennessee, 37130-2450

United States

Arlington Research Center

Arlington, Texas, 76011-3800

United States

Bellaire Dermatology Associates

Bellaire, Texas, 77401-3505

United States

UT Physicians Dermatology - Bellaire Station

Bellaire, Texas, 77401

United States

Modern Research Associates

Dallas, Texas, 75231-6077

United States

North Texas Center for Clinical Research

Frisco, Texas, 75034

United States

San Antonio

San Antonio, Texas, 78213-2250

United States

Texas Dermatology and Laser Specialists-San Antonio-7703 Floyd Curl Dr

San Antonio, Texas, 78218-3128

United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229-3409

United States

Houston Center for Clinical Research, LLC

Sugar Land, Texas, 77479-1001

United States

Center For Clinical Studies, LTD. LLP - 451 N Texas Ave

Webster, Texas, 77598-4927

United States

Virginia Clinical Research - 6160 Kempsville Cir

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Takeda

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04

Study Completion Date2026-05-07

Study Record Updates

Study Start Date2024-09-04

Study Completion Date2026-05-07

Terms related to this study

Keywords Provided by Researchers

Latitude Psoriasis 3
Latitude Research Program
Latitude PsO OLE

Additional Relevant MeSH Terms

Plaque Psoriasis