The Priority Review

Clinical trials

TAK-279 in two psoriasis types: PASI 75 reached by 37.5 percent with GPP, 80.0 percent with EP at Week 16

In Takeda's open-label Phase 3 study of 18 adults, 37.5 percent with generalized pustular psoriasis and 80.0 percent with erythrodermic psoriasis reached a 75 percent PASI improvement at Week 16. The registry record lists Week 16 results; the Week 52 secondary outcomes are not yet posted.

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In Takeda's open-label Phase 3 study of TAK-279, 37.5 percent of 8 adults with generalized pustular psoriasis and 80.0 percent of 10 adults with erythrodermic psoriasis reached at least a 75 percent improvement in Psoriasis Area and Severity Index score at Week 16, the study record shows. The study enrolled 18 participants across the two psoriasis types, and the record now lists Week 16 results for both.

Week 16 results by psoriasis type
Psoriasis type75 percent PASI improvementStatic Physician's Global AssessmentCompleted the study
Generalized pustular psoriasis (8 participants)37.5 percent (8 analyzed)33.3 percent (6 analyzed)4 of 8
Erythrodermic psoriasis (10 participants)80.0 percent (10 analyzed)80.0 percent (10 analyzed)9 of 10

From the trial registry record NCT06323356, results first submitted October 14, 2026.

Why it matters

The record's brief summary says the main aim is to check whether TAK-279 improves symptoms of generalized pustular psoriasis or erythrodermic psoriasis, and to record side effects. All participants were assigned to TAK-279, so the record holds no comparison arm. The record lists the study as non-randomized with no masking.

Week 16 results

Results were first submitted on October 14, 2026. The record lists two primary outcomes at Week 16, each in percent of participants.

  • Static Physician's Global Assessment of Clear (0) or Almost Clear (1) with a decrease of at least 2 points from baseline: 33.3 percent with generalized pustular psoriasis (6 participants analyzed) and 80.0 percent with erythrodermic psoriasis (10 analyzed).
  • At least 75 percent improvement from baseline in Psoriasis Area and Severity Index score: 37.5 percent with generalized pustular psoriasis (8 analyzed) and 80.0 percent with erythrodermic psoriasis (10 analyzed).

The record says that, as planned in the statistical analysis plan, participants with a static Physician's Global Assessment score of 0 or 1 at baseline were excluded from the first analysis. That is why 6 rather than 8 participants with generalized pustular psoriasis were analyzed there.

Trial size and participants

The study began on March 19, 2024, and the primary completion date was October 17, 2025. Each participant took TAK-279, 30 mg, as a tablet by mouth once daily from Day 1 up to Week 52. The record says participants stay in the study for up to 61 weeks, including 52 weeks of treatment.

Of the 18 participants, 8 had generalized pustular psoriasis and 10 had erythrodermic psoriasis. The record lists 13 aged between 18 and 65 years and 5 aged 65 years or older, with 5 women and 13 men. It did not collect race or ethnicity from any participant.

Participant flow

In the participant flow, 4 of 8 participants with generalized pustular psoriasis completed the study, against 9 of 10 with erythrodermic psoriasis. Two participants with generalized pustular psoriasis left for an adverse event and 2 for lack of efficacy. One participant with erythrodermic psoriasis left for an adverse event.

Safety measures

The record bases its safety summary on data available as of the primary completion date, October 17, 2025. It reports 0 deaths in either group. Adverse events classed as serious affected 2 of 8 participants with generalized pustular psoriasis and 1 of 10 with erythrodermic psoriasis. Other adverse events at the 5 percent reporting threshold affected 8 of 8 and 9 of 10.

Eosinophil count increased in 3 of 8 participants with generalized pustular psoriasis and in none with erythrodermic psoriasis. Nasopharyngitis affected 2 of 8 and 3 of 10.

What remains uncertain

  • The static Physician's Global Assessment outcomes at Week 52 and at both Weeks 16 and 52 are marked as disclosed at final posting, with an anticipated posting date of July 2027, the record shows.

Sources