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NCT04263610: TRANSITION
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
Phase 4 trial testing Dimethyl fumarate (DMF) standard scheme in Plaque Psoriasis in 190 participants. Completed in 16 February 2022.
16 February 2022
Quick facts
| Lead sponsor | Almirall, S.A. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 190 |
| Start date | 4 September 2019 |
| Primary completion | 16 February 2022 |
| Estimated completion | 16 February 2022 |
| Sites | 3 locations across United Kingdom, Germany |
Drugs / interventions tested
- Dimethyl fumarate (DMF) standard scheme — full drug profile →
- Dimethyl fumarate (DMF) simplified scheme — full drug profile →
- Tildrakizumab (TILDRAKIZUMAB) — full drug profile →
Conditions studied
- Plaque Psoriasis — all drugs for Plaque Psoriasis →
Sponsor
Almirall, S.A. — 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 purpose of this study is to assess the efficacy, safety and tolerability of Tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to Dimethyl fumarate (DMF) at Week 16. The study consists of two parts. Part 1 will include the first 16 weeks of the Treatment Period and Part 2 will include the last 24 weeks of the Treatment Period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Therapeutic Development Based on the Immunopathogenic Mechanisms of Psoriasis.
Tseng JC, Chang YC, Huang CM, Hsu LC, et al · · 2021 · cited 27× · PMID 34371756 · DOI 10.3390/pharmaceutics13071064
Verify or expand the search:
- PubMed search for NCT04263610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Almirall, S.A. trials
Trials by the same sponsor.
- NCT07471932 — A Study of LAD106 in Healthy Adult Participants · Phase 1 · recruiting
- NCT07311564 — A Study of LAD603 in Adults With Alopecia Areata · Phase 2 · recruiting
- NCT06135415 — A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis · Phase 3 · completed
- NCT06200597 — A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects · Phase 1 · completed
- NCT05990725 — Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis · Phase 3 · active not 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 NCT04263610 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Almirall, S.A.
- Last refreshed: 27 May 2022
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/NCT04263610.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing