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TAK-279 for Plaque Psoriasis

Verified Trial
Phase 3
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You have been diagnosed with Plaque Psoriasis
Plaque psoriasis for at least 6 months
Timeline
Screening 14 days
Treatment 60 weeks
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial tests a new drug to see if it reduces psoriasis skin plaques, compared to an approved drug and placebo. Participants will be monitored for up to 69 weeks.

Who is the study for?
This trial is for people who have had plaque psoriasis for at least 6 months and it's moderate to severe. They should be candidates for light therapy or systemic treatment but can't join if they've had other types of psoriasis, recent infections, or previous exposure to TAK-279.Check my eligibility
What is being tested?
The study tests how well a new medication, TAK-279, works in reducing skin plaques compared to an existing drug called Apremilast and a placebo. Participants will randomly receive one of these treatments over the course of up to 69 weeks.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications like TAK-279 and Apremilast may include digestive issues, headaches, potential risk of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 14 days
Treatment ~ 60 weeks
Follow Up ~4 weeks
This trial's timeline: 14 days for screening, 60 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo
Secondary outcome measures
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo
+48 more

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309
30%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
viral gastroenteritis
5%
right flank pain
5%
abscess right hand
5%
cyst left inner thigh
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: TAK-279Experimental Treatment1 Intervention
Group II: ApremilastActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-279
2023
Completed Phase 1
~180

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,203 Previous Clinical Trials
4,176,944 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
488,272 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants signed up to partake in this experiment?

"Affirmative. According to information from clinicaltrials.gov, this study is currently recruiting patients and was first posted on November 6th 2023 with its most recent update occurring on the 21st of November. The research requires 1000 participants at a single site to complete the trial."

Answered by AI

Are new participants currently being accepted for this investigation?

"Indeed, the information posted on clinicaltrials.gov attests to this trial's active recruitment status. It was initially added on November 6th 2023 and has since been amended once more as of November 21st 2023. The researchers aim to recruit 1000 volunteers from a single medical facility."

Answered by AI

Has the FDA sanctioned TAK-279 for therapeutic implementation?

"Our team at Power deems the safety of TAK-279 to be a 3, as clinical trials have demonstrated both efficacy and numerous rounds of data supporting its safety."

Answered by AI

Who else is applying?

What site did they apply to?
Schweiger Dermatology Group
Divine Dermatology & Aesthetics
Noble Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I want to get better. And to see what other meds might help me. My itching is horrible I stretch all day all night nothing helps it.
PatientReceived 2+ prior treatments
I am not sure if I have this illness, I would love to know if I do , I am Diabetic,high pretension,Colesterol !!!
PatientReceived no prior treatments
I am on cosentyx and bethamadizone and calcipotriene creams but still haven't been in remission I over a year I'm just wondering what else I can do to get my skin clear.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Noble Clinical Research: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108544.
All > Psoriasis > Plaque Psoriasis
~667 spots leftby Jul 2025
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