A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

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 56 weeks.

Recruitment Criteria

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
More Inclusion & Exclusion Criteria

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.

NCT06088043
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, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Additional Details

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 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279. 2. Placebo. 3. Apremilast. This multi-center trial will be conducted worldwide. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 52 weeks (1 year). There will be a safety follow-up visit 4 weeks after their last day of treatment.

Arms & Interventions

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.

Phoenix, Arizona

Status

Not yet recruiting

Address

Saguaro Dermatology Associates, LLC - Probity - PPDS

Phoenix, Arizona, 85008-3884

Site Contact

Site Contact

dhamann@saguaroderm.com

480-562-3610

First OC Dermatology - Fountain Valley, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology - Fountain Valley

Fountain Valley, California, 92708-3701

Center for Dermatology Clinical Research, Fremont, California

Status

Recruiting

Address

Center for Dermatology Clinical Research

Fremont, California, 94538-1614

Site Contact

Site Contact

sdhaw@yahoo.com

510-797-0140

Driven Research LLC, Coral Gables, Florida

Status

Recruiting

Address

Driven Research LLC

Coral Gables, Florida, 33134-3901

Fort Lauderdale, Florida

Status

Recruiting

Address

FXM Clinical Research Ft. Lauderdale, LLC

Fort Lauderdale, Florida, 33308-5211

Site Contact

Site Contact

igor.chaplik@fxmresearch.com

954-368-4406

Direct Helpers Research Center, Hialeah, Florida

Status

Recruiting

Address

Direct Helpers Research Center

Hialeah, Florida, 33012-3618

Site Contact

Site Contact

Don@dhrtrials.com

305-324-2110

FXM Clinical Research Miami, LLC, Miami, Florida

Status

Recruiting

Address

FXM Clinical Research Miami, LLC

Miami, Florida, 33175-3582

Site Contact

Site Contact

hector.wiltz@fxmresearch.com

305-220-5222

Renstar Medical Research -21 NE 1st Ave, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research -21 NE 1st Ave

Ocala, Florida, 34470-6657

Site Contact

Site Contact

ashley.cauthen@renstar.net

352-629-5800

Marietta, Georgia

Status

Recruiting

Address

Marietta Dermatology & The Skin Cancer Center - Marietta

Marietta, Georgia, 30060-7902

Site Contact

Site Contact

mknautz@mariettaderm.com

770-421-2037

Georgia Skin and Cancer Clinic, Savannah, Georgia

Status

Not yet recruiting

Address

Georgia Skin and Cancer Clinic

Savannah, Georgia, 31419-1768

Site Contact

Site Contact

ssmith@georgiaskinandcancer.com

919-830-4841

Leavitt Clinical Research, Idaho Falls, Idaho

Status

Recruiting

Address

Leavitt Clinical Research

Idaho Falls, Idaho, 83404-8322

Arlington Dermatology, Rolling Meadows, Illinois

Status

Recruiting

Address

Arlington Dermatology

Rolling Meadows, Illinois, 60008-3811

Site Contact

Site Contact

bukhalom@hotmail.com

847-392-5440

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, 46256-4697

Site Contact

Site Contact

kdawes@ecommunity.com

317-516-5030

Kindred Hair & Skin Center - CAR, Columbia, Maryland

Status

Not yet recruiting

Address

Kindred Hair & Skin Center - CAR

Columbia, Maryland, 21046-1246

Troy, Michigan

Status

Recruiting

Address

Revival Research Corporation - Michigan - ClinEdge - PPDS

Troy, Michigan, 48084-3536

Site Contact

Site Contact

amoiin@rev-research.com

248-564-1485

Grekin Skin Institute, Warren, Michigan

Status

Recruiting

Address

Grekin Skin Institute

Warren, Michigan, 48088-3671

Site Contact

Site Contact

sg222@aol.com

586-759-5525

Henderson Clinical Trials, Henderson, Nevada

Status

Recruiting

Address

Henderson Clinical Trials

Henderson, Nevada, 89052-5016

Site Contact

Site Contact

vsayal@hendersontrials.com

725-218-3236

ALLCUTIS Research, LLC., Portsmouth, New Hampshire

Status

Recruiting

Address

ALLCUTIS Research, LLC.

Portsmouth, New Hampshire, 03801

Site Contact

Site Contact

ajarell@activmedresearch.com

603-319-8863

New York, New York

Status

Not yet recruiting

Address

Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS

New York, New York, 10003-3314

Site Contact

Site Contact

ghan2@northwell.edu

212-844-8800

Accellacare of Cary, Cary, North Carolina

Status

Recruiting

Address

Accellacare of Cary

Cary, North Carolina, 27518-7414

Site Contact

Site Contact

cathyhren@gmail.com

919-342-3447

Bexley, Ohio

Status

Recruiting

Address

Bexley Dermatology Research - Probity - PPDS

Bexley, Ohio, 43209

Site Contact

Site Contact

matt.zirwas@gmail.com

614-293-4464

Charleston, South Carolina

Status

Not yet recruiting

Address

Clinical Research Center of the Carolinas, LLC

Charleston, South Carolina, 29407-5347

Site Contact

Site Contact

skindoc@dermandlaser.com

843-556-8886

Murfreesboro, Tennessee

Status

Recruiting

Address

International Clinical Research-Tennessee LLC

Murfreesboro, Tennessee, 37130-2450

Site Contact

Site Contact

cfeser@icresearch.net

615-410-3460

Bellaire Dermatology Associates, Bellaire, Texas

Status

Recruiting

Address

Bellaire Dermatology Associates

Bellaire, Texas, 77401-3505

Site Contact

Site Contact

cteller@bellairedermatology.com

713-661-4383

San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research PA - San Antonio

San Antonio, Texas, 78213-2250

Site Contact

Site Contact

drlee@progclin.com

210-614-5557

International Sites

Surrey, British Columbia, Canada

Status

Not yet recruiting

Address

Enverus Medical Research - Probity - PPDS

Surrey, British Columbia, V3R 6A7

Site Contact

Site Contact

lalbrecht@enverusmedical.com

(604) 495-8278

CCA Medical Research - Probity - PPDS, Ajax, Ontario, Canada

Status

Recruiting

Address

CCA Medical Research - Probity - PPDS

Ajax, Ontario, L1S 7K8

Site Contact

Site Contact

dnadam@ccamedicalresearch.com

(905) 427-3996

Barrie, Ontario, Canada

Status

Not yet recruiting

Address

SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS

Barrie, Ontario, L4M 7G1

Site Contact

Site Contact

derm@simcoderm.com

(705) 503-6333

Etobicoke, Ontario, Canada

Status

Not yet recruiting

Address

Kingsway Clinical Research - Probity - PPDS

Etobicoke, Ontario, M8X 1Y9

Site Contact

Site Contact

epoulos@yahoo.com

(416) 231-0100

Guelph, Ontario, Canada

Status

Recruiting

Address

Guelph Dermatology Research - Probity - PPDS

Guelph, Ontario, N1H 1B1

Site Contact

Site Contact

guelphdermrxd@gmail.com

(519) 836-7345

Mediprobe Research Inc, London, Ontario, Canada

Status

Not yet recruiting

Address

Mediprobe Research Inc

London, Ontario, N5X 2P1

Site Contact

Site Contact

agupta@mediproberesearch.com

(888) 888-8888

North Bay, Ontario, Canada

Status

Recruiting

Address

North Bay Dermatology Center - Probity - PPDS

North Bay, Ontario, P1B 3Z7

Site Contact

Site Contact

lesrosoph@gmail.com

(705) 476-4539

North York, Ontario, Canada

Status

Not yet recruiting

Address

North York Research Inc. - Probity - PPDS

North York, Ontario, M2M 4J5

Site Contact

Site Contact

niakosari@bnderm.com

(416) 222-7546

Research Toronto - Probity - PPDS, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Research Toronto - Probity - PPDS

Toronto, Ontario, M4W 2N4

Site Contact

Site Contact

sh@dermonbloor.com

(416) 962-0123

Warszawa, Mazowieckie, Poland

Status

Not yet recruiting

Address

Klinika Ambroziak Dermatologia - ul. Kosiarzy 9A

Warszawa, Mazowieckie, 02-008

Site Contact

Site Contact

principal@klinikaambroziak.pl

+48608307575

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.