Evaluating TAK-279 for treating severe psoriasis

A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Adult Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

This study tests whether a new treatment called TAK-279 can help people with severe psoriasis feel better over 61 weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 20 sites (Nagoya, Aichi and 19 other locations)
• Trial ID: NCT06323356 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of TAK-279 in improving symptoms of Generalized Pustular Psoriasis (GPP) and Erythrodermic Psoriasis (EP). Participants diagnosed with these conditions will receive TAK-279 treatment over a period of up to 61 weeks, including 52 weeks of active treatment. Regular clinic visits will be required to monitor symptoms and side effects throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Generalized Pustular Psoriasis or Erythrodermic Psoriasis who are candidates for phototherapy or systemic therapy.

Not a fit: Patients with other forms of psoriasis or those with a history of recent infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate the symptoms of severe psoriasis for affected patients.

How similar studies have performed: While this approach is focused on a specific treatment, similar studies targeting severe psoriasis have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. A diagnosis of GPP or EP prior to the screening visit.
2. Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

1. Other forms of psoriasis.
2. History of recent infection.
3. Any prior exposure to TAK-279, or participation in any study that included a TYK2 inhibitor.

Other protocol defined inclusion/exclusion criteria apply.

Where this trial is running

Nagoya, Aichi and 19 other locations

• Nagoya City University Hospital — Nagoya, Aichi, Japan (Recruiting)
• Fujita Health University Hospital — Toyoake, Aichi, Japan (Recruiting)
• Kimitsu Chuo Hospital — Kisarazu, Chiba, Japan (Recruiting)
• Juntendo University Urayasu Hospital — Urayasu, Chiba, Japan (Recruiting)
• Hospital of the University of Occupational and Environmental Health, Japan — Kitakyushu, Fukuoka, Japan (Recruiting)
• Isesaki Municipal Hospital — Isesaki, Gunma, Japan (Recruiting)
• Kobe University Hospital — Kobe, Hyogo, Japan (Recruiting)
• Tokai University Hospital — Isehara, Kanagawa, Japan (Recruiting)
• Mie University Hospital — Tsu, Mie, Japan (Recruiting)
• Kansai Medical University Hospital — Hirakata, Osaka, Japan (Recruiting)
• Saitama Medical University Hospital — Iruma, Saitama, Japan (Recruiting)
• St.Luke's International Hospital — Chuo City, Tokyo, Japan (Recruiting)
• Teikyo University Hospital — Itabashi-ku, Tokyo, Japan (Recruiting)
• The Jikei University Hospital — Minato-ku, Tokyo, Japan (Recruiting)
• Tokyo Medical University Hospital — Shinjuku-ku, Tokyo, Japan (Recruiting)
• Fukuoka University Hospital — Fukuoka, Japan (Recruiting)
• University Hospital, Kyoto Prefectural University of Medicine — Kyoto, Japan (Recruiting)
• Okayama University Hospital — Okayama, Japan (Recruiting)
• Nippon Life Hospital — Osaka, Japan (Recruiting)
• Osaka Metropolitan University Hospital — Osaka, Japan (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Generalized Pustular Psoriasis; Erythrodermic Psoriasis