A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period
Study Purpose
The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
1. Plaque psoriasis for at least 6 months. 2. Moderate to severe disease. 3. Candidate for phototherapy or systemic therapy.Exclusion Criteria:
1. Other forms of psoriasis. 2. History of recent infection. 3. Prior exposure to TAK-279 or active comparator. Other protocol defined inclusion/exclusion criteria apply.Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06108544 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Takeda |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Study Director |
| Principal Investigator Affiliation | Takeda |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Canada, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plaque Psoriasis |
| Study Website: | View Trial Website |
The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis. The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):
- - TAK-279.
- - Apremilast.
- - Placebo.
Arms
Experimental: TAK-279
Placebo Comparator: Placebo
Active Comparator: Apremilast
Interventions
Drug: - TAK-279
Specified drug on specified days.
Drug: - Placebo
Specified drug on specified days.
Drug: - Apremilast
Specified drug on specified days.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Status
Recruiting
Address
Cahaba Dermatology Skin Health Center
Hoover, Alabama, 35244-2111
Status
Recruiting
Address
Medical Dermatology Specialists
Phoenix, Arizona, 85006-2722
Status
Not yet recruiting
Address
Noble Clinical Research
Tucson, Arizona, 85704-7892
Status
Recruiting
Address
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916-6103
Status
Recruiting
Address
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913-6475
Status
Recruiting
Address
Zenith Research, Inc.
Beverly Hills, California, 90211-1705
Status
Recruiting
Address
UNISON Clinical Trials (Shahram Jacobs md inc.)
Encino, California, 91436-2428
Status
Recruiting
Address
First OC Dermatology Research Inc.
Fountain Valley, California, 92708-3701
Status
Recruiting
Address
Long Beach Research Institute, LLC
Long Beach, California, 90805-4587
Status
Recruiting
Address
Metropolis Dermatology Downtown LA - Probity - PPDS
Los Angeles, California, 90017-5310
Status
Recruiting
Address
Northridge Clinical Trials
Northridge, California, 91325-4122
Status
Recruiting
Address
Therapeutics Clinical Research
San Diego, California, 92123-1523
Status
Not yet recruiting
Address
University Clinical Trials
San Diego, California, 92123
Status
Recruiting
Address
Dermatology Institute and Skin Care Center
Santa Monica, California, 90404-2216
Status
Recruiting
Address
Revival Research Corporation - Florida - ClinEdge - PPDS
Doral, Florida, 33122-1902
Status
Recruiting
Address
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014-5602
Status
Recruiting
Address
Florida Academic Centers Research
Miami, Florida, 33136-1003
Status
Recruiting
Address
FXM Research Miramar
Miramar, Florida, 33027-4714
Status
Recruiting
Address
Lenus Research & Medical Group
Sweetwater, Florida, 33172-2741
Status
Recruiting
Address
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, 33607-6429
Status
Not yet recruiting
Address
Olympian Clinical Research - 6331 Memorial Hwy
Tampa, Florida, 33615
Status
Not yet recruiting
Address
Divine Dermatology and Aesthetics, LLC
Atlanta, Georgia, 30315-2042
Status
Not yet recruiting
Address
Advanced Medical Research, PC
Atlanta, Georgia, 30342-1418
Status
Not yet recruiting
Address
Skin Care Physicians of Georgia
Macon, Georgia, 31217-3861
Status
Recruiting
Address
NorthShore Medical Group Dermatology - Skokie
Skokie, Illinois, 60077-1049
Status
Recruiting
Address
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana, 47129-2201
Status
Recruiting
Address
Skin Sciences, PLLC
Louisville, Kentucky, 40217-1444
Status
Recruiting
Address
Dermatology Specialists Research - 3810 Springhurst Blvd
Louisville, Kentucky, 40241-6162
Status
Not yet recruiting
Address
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605-1213
Status
Recruiting
Address
Lawrence J Green, MD LLC
Rockville, Maryland, 20850-6363
Status
Not yet recruiting
Address
Allcutis Research LLC
Beverly, Massachusetts, 01915
Status
Recruiting
Address
Beacon Clinical Research LLC
Brockton, Massachusetts, 02301
Status
Not yet recruiting
Address
David Fivenson MD Dermatology PLLC
Ann Arbor, Michigan, 48103-9746
Status
Recruiting
Address
University of Michigan Hospital - 1500 E Medical Center Dr
Ann Arbor, Michigan, 48109-5360
Status
Recruiting
Address
Oakland Hills Dermatology - 3400 Auburn Rd
Auburn Hills, Michigan, 48326-3396
Status
Recruiting
Address
Minnesota Clinical Study Center
Fridley, Minnesota, 55432-3134
Status
Recruiting
Address
Skin Specialists PC
Omaha, Nebraska, 68144
Status
Not yet recruiting
Address
Vivida Dermatology - Flamingo Rd - Probity - PPDS
Las Vegas, Nevada, 89119-5190
Status
Not yet recruiting
Address
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, 03801
Status
Recruiting
Address
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Status
Not yet recruiting
Address
Montefiore Dermatology - BRANY - PPDS
Bronx, New York, 10467-1402
Status
Recruiting
Address
Mount Sinai Doctors -234 E 85th St
New York, New York, 10029-6504
Status
Recruiting
Address
Sadick Research Group
New York, New York, 10075-0385
Status
Recruiting
Address
Derm Research Center of NY
Stony Brook, New York, 11790
Status
Recruiting
Address
The Skin Surgery Center for Clinical Research - Objective Health - PPDS
Winston-Salem, North Carolina, 27103-7109
Status
Not yet recruiting
Address
ClinOhio Research Services
Columbus, Ohio, 43213-4445
Status
Recruiting
Address
Wright State Physicians
Fairborn, Ohio, 45324
Status
Recruiting
Address
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124-4005
Status
Recruiting
Address
Oregon Medical Research Center PC
Portland, Oregon, 97239-4501
Status
Not yet recruiting
Address
University of Pittsburgh Medical Center-3601 5th Ave
Pittsburgh, Pennsylvania, 15213-3403
Status
Recruiting
Address
Cumberland Skin Center for Clinical Research - Objective Health - PPDS
Hermitage, Tennessee, 37076-3497
Status
Recruiting
Address
Tennessee Clinical Research Center
Nashville, Tennessee, 37215-2888
Status
Recruiting
Address
Arlington Center for Dermatology
Arlington, Texas, 76011-3800
Status
Recruiting
Address
UT Physicians Dermatology - Bellaire Station
Bellaire, Texas, 77401-3535
Status
Recruiting
Address
Modern Research Associates
Dallas, Texas, 75231-6077
Status
Recruiting
Address
North Texas Center for Clinical Research
Frisco, Texas, 75034
Status
Recruiting
Address
Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS
Pflugerville, Texas, 78660-6148
Status
Recruiting
Address
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218-3128
Status
Recruiting
Address
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229-3409
Status
Recruiting
Address
Houston Center for Clinical Research, LLC
Sugar Land, Texas, 77479-1001
Status
Recruiting
Address
Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
Webster, Texas, 77598-4927
Status
Recruiting
Address
Virginia Clinical Research - 6160 Kempsville Cir
Norfolk, Virginia, 23507
International Sites
Status
Not yet recruiting
Address
CARe Clinic
Red Deer, Alberta, T4N 7C3
Status
Recruiting
Address
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba, R3E 0V9
Status
Recruiting
Address
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
Hamilton, Ontario, L8L 3C3
Status
Not yet recruiting
Address
Dermatrials Research
Hamilton, Ontario, L8N 1Y2
Status
Not yet recruiting
Address
DermEffects - Probity - PPDS
London, Ontario, N6H 5L5
Status
Recruiting
Address
Lynderm Research Inc - Probity - PPDS
Markham, Ontario, L3P 1X3
Status
Recruiting
Address
DermEdge Research - Probity - PPDS
Mississauga, Ontario, L5H 1G9
Status
Recruiting
Address
The Centre for Clinical Trials Inc. - Probity - PPDS
Oakville, Ontario, L6J 7W5
Status
Recruiting
Address
SKiN Centre for Dermatology - Peterborough - Probity - PPDS
Peterborough, Ontario, K9J 1Z2
Status
Not yet recruiting
Address
Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
Richmond Hill, Ontario, L4B 1M5
Status
Recruiting
Address
Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
Richmond Hill, Ontario, L4C 9M7
Status
Recruiting
Address
Canadian Dermatology Centre - Probity - PPDS
Toronto, Ontario, M3B 0A7
Status
Recruiting
Address
Toronto Research Centre - Probity - PPDS
Toronto, Ontario, M3H 5Y8
Status
Recruiting
Address
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario, N2J 1C4
Status
Recruiting
Address
XLR8 Medical Research - Probity - PPDS
Windsor, Ontario, N8X 3V6
Status
Recruiting
Address
Siena Medical Research
Westmount, Quebec, H3Z 2S6
Status
Not yet recruiting
Address
Skinsense Medical Research - Probity - PPDS
Saskatoon, Saskatchewan, S7K 0H6
