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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
Plaque psoriasis for at least 6 months
Moderate to severe disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 24, 40 and 52
Awards & highlights

Study Summary

This trial will compare how well TAK-279, apremilast, and placebo reduce skin plaques in people with plaque psoriasis. Participants will be in the study for up to 56 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 or the active comparator.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 inactive substance (placebo) and an approved drug called Apremilast. Participants will randomly receive one of these treatments over a period of up to 56 weeks.See study design
What are the potential side effects?
Possible side effects may include reactions similar to those seen with other medications for psoriasis such as stomach issues, headaches, potential liver changes, and increased risk of infection. The exact side effects of TAK-279 are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had plaque psoriasis for at least 6 months.
Select...
My condition is moderate to severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 24, 40 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24, 40 and 52 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 (PASI-75 Response) 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
+44 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

Who is running the clinical trial?

TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,344 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
488,672 Total Patients Enrolled

Frequently Asked Questions

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

Is TAK-279 a safe option for individuals to consider?

"The safety of TAK-279 has been established in numerous studies, thus giving it a score of 3. This is due to the fact that this treatment is currently being tested at Phase 3 trials which involve evidence supporting efficacy and multiple rounds demonstrating its security."

Answered by AI

Are there any remaining vacancies for participants in this medical trial?

"This experiment, which was initially posted on November 6th 2023 and recently revised on November 21st of the same year, is still in need of participants. Clinicaltrials.gov confirms this information."

Answered by AI

What is the maximum amount of patients being accepted for this trial?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is presently recruiting patients, with the study having been posted on November 6th 2023 and last updated on November 21st of the same year. 600 subjects are required from one medical site to complete it."

Answered by AI

Who else is applying?

What site did they apply to?
First OC Dermatology Research Inc
What portion of applicants met pre-screening criteria?
Met criteria
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 52 Weeks of Treatment
2023. "A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088043.
All > Psoriasis > Plaque Psoriasis
~400 spots leftby Aug 2025
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