Phase 3 Psoriasis Trial, Recruiting NCT07250802 Sponsor: Takeda Condition: Psoriasis
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Phase 3 Psoriasis Trial, Recruiting

NCT07250802
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with chronic plaque psoriasis for at least 6 months before the screening visit.
  • Your psoriasis has been stable — meaning no major flare-ups or changes in how it looks — for at least 6 months before screening.
  • Your psoriasis is considered moderate to severe, based on specific scores measured by a doctor at the screening visit and on Day 1.
  • Your psoriasis covers at least 10% of your total body surface area at the screening visit and on Day 1.
  • You are a suitable candidate for light therapy (phototherapy) or medication taken by mouth or injection (systemic therapy).
  • For one part of the trial (Part A, Group 1): You are male or female, aged 12 up to (but not including) 18 years old.
  • For another part of the trial (Part A, Group 2 and Part B): You are male or female, aged 4 up to (but not including) 12 years old.
  • For Part A, Group 1 only: You weigh at least 40 kilograms (about 88 pounds) at the time of screening.

Who may not be able to join:

  • You have a type of psoriasis other than plaque psoriasis, such as pustular, guttate, or drug-triggered psoriasis (a small amount of inverse psoriasis may be acceptable — confirm with trial site).
  • You need regular medication (other than anti-inflammatory pain relievers like ibuprofen) to treat an immune system condition during the trial.
  • You have another skin condition that, in the doctor's opinion, would affect how trial results are measured.
  • You have a history of active tuberculosis (TB) at any point, currently show signs of TB, or have signs of a latent (inactive) TB infection.
  • You currently have an active herpes virus infection (including cold sores or shingles), or have had a serious herpes infection in the past.
  • You have a history of long-term or repeatedly occurring bacterial infections.
  • You have a history of serious rare infections that typically affect people with weakened immune systems (confirm with trial site).
  • You have any significant health condition, unstable health status, or abnormal test results that a doctor believes could put you at risk or affect the trial results.
  • You have previously taken the study drug (zasocitinib, also known as TAK-279 or NDI-034858) or any similar type of drug, or participated in a trial involving this type of drug — unless it has been confirmed in writing that you did not receive the active drug.
  • Your vaccinations are not up to date according to the recommended immunization schedule for children in your country.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Takeda

Phone: +1-877-825-3327

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
4 December 2025
Est. completion
24 January 2033

Where this trial is recruiting

🇨🇳 China 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Part A: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater than or Equal to (>=) 2-Point Decrease From Baseline at Week 16; Part A: Percentage of Participants Achieving >= 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16; Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib; Part B: Time to Maximum Concentration (Tmax) of Zasocitinib; Part B: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-La...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov