Your session is about to expire
← Back to Search
Other
TAK-279 for Plaque Psoriasis
Verified Trial
Phase 3
Waitlist Available
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
Pivotal Trial
Summary
This trial is testing a new drug called TAK-279 to see if it can help people with moderate to severe plaque psoriasis. The study will compare TAK-279 to an existing treatment called apremilast, which is approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis. The goal is to find out if TAK-279 can better reduce the skin problems associated with this condition.
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.
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.
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 belowTimeline
Screening ~ 14 days1 visit
Treatment ~ 60 weeks15 visits
Follow Up ~ 4 weeks1 visit
Screening ~ 14 days
Treatment ~ 60 weeks
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
+45 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~390
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for plaque psoriasis include TNF-alpha inhibitors, IL-12/23 inhibitors, and small molecule inhibitors like tofacitinib. TNF-alpha inhibitors work by blocking the tumor necrosis factor-alpha, a cytokine involved in systemic inflammation, thereby reducing inflammation and plaque formation.
IL-12/23 inhibitors target interleukins 12 and 23, which are key cytokines in the inflammatory pathway of psoriasis, helping to reduce the immune response that leads to plaque formation. Small molecule inhibitors like tofacitinib target the Jak/Stat signaling pathway, which is involved in the immune response and inflammation.
These treatments are crucial for patients with plaque psoriasis as they help manage the chronic inflammation and reduce the severity of skin lesions, improving quality of life.
Epidermal mTORC1 Signaling Contributes to the Pathogenesis of Psoriasis and Could Serve as a Therapeutic Target.Potential antipsoriatic effect of chondroitin sulfate through inhibition of NF-κB and STAT3 in human keratinocytes.
Epidermal mTORC1 Signaling Contributes to the Pathogenesis of Psoriasis and Could Serve as a Therapeutic Target.Potential antipsoriatic effect of chondroitin sulfate through inhibition of NF-κB and STAT3 in human keratinocytes.
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
1,240 Previous Clinical Trials
4,148,363 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
501,404 Total Patients Enrolled