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NCT06108544
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period
Phase 3 trial testing TAK-279 in Plaque Psoriasis in 1,108 participants. Completed in 7 November 2025.
6 December 2024
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1,108 |
| Start date | 6 November 2023 |
| Primary completion | 6 December 2024 |
| Estimated completion | 7 November 2025 |
| Sites | 217 locations across France, Greece, United Kingdom, Germany, Hungary, Israel, Poland, Argentina |
Drugs / interventions tested
- TAK-279 — full drug profile →
- Placebo
- Apremilast (APREMILAST) — full drug profile →
Conditions studied
- Plaque Psoriasis — all drugs for Plaque Psoriasis →
Sponsor
Takeda — full company profile →
Who can join
18 and older, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
New and Emerging Oral/Topical Small-Molecule Treatments for Psoriasis.
Carmona-Rocha E, Rusiñol L, Puig L. · · 2024 · cited 28× · PMID 38399292 · DOI 10.3390/pharmaceutics16020239 -
Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial.
Armstrong AW, Gooderham M, Lynde C, Maari C, et al · · 2024 · cited 21× · PMID 39167366 · DOI 10.1001/jamadermatol.2024.2701 -
Emerging Oral Therapies for the Treatment of Psoriasis: A Review of Pipeline Agents.
Drakos A, Torres T, Vender R. · · 2024 · cited 21× · PMID 38258121 · DOI 10.3390/pharmaceutics16010111 -
Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial.
Elbuluk N, Armstrong AW, Vender R, Bhutani T, et al · · 2026 · PMID 42143206 · DOI 10.1007/s13555-026-01738-6 -
Probing Allosteric Kinase Modulators as Next Game-Changers in Fighting Neurodegeneration.
Roggiolani E, Rosini M, Minarini A, Basagni F. · · 2026 · PMID 42041106 · DOI 10.1021/acs.jmedchem.5c03783
Verify or expand the search:
- PubMed search for NCT06108544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TAK-279
Trials testing the same drug.
- NCT06550076 — A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis · Phase 3 · active not recruiting
- NCT06111547 — A Study of TAK-279 in Healthy Chinese Adults · Phase 1 · completed
- NCT06258265 — A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements · Phase 1 · completed
- NCT06254950 — A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to · Phase 2 · recruiting
- NCT06290050 — A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults · Phase 1 · completed
Other recruiting trials for Plaque Psoriasis
Currently open trials in the same condition.
- NCT07357831 — A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psor · Phase 3 · recruiting
- NCT07250802 — A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis · Phase 3 · recruiting
- NCT06979453 — A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants Wit · Phase 3 · recruiting
- NCT07234591 — A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis · NA · recruiting
- NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting
Other Takeda trials
Trials by the same sponsor.
- NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
- NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
- NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
- NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
- NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06108544 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 20 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06108544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing