Clinical trial · Interventional
TYK2 Inhibition in Paradoxical Psoriasis
Tyrosine Kinase 2 (TYK2) Inhibition in Paradoxical Psoriasis A Randomized, Double-blind, Placebo-controlled Multi-center Study Evaluating the Effect of Deucravacitinib on Severity of Psoriasis in Patients With Paradoxical Psoriasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): External research funds were canceled, so study could unforunately not be continued
Summary
Brief summary (as posted)
Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists. This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deucravacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 'Deucravacitinib'
- description
- Deucravacitinib 6mg oral intake once daily for 4 weeks
- interventionNames
- Drug: Deucravacitinib
- type
- PLACEBO_COMPARATOR
- label
- 'Placebo'
- description
- Matching Placebo oral intake once daily for 4 weeks
- interventionNames
- Drug: Deucravacitinib
Primary outcomes (1)
- measure
- Paradoxical Psoriasis Investigator Global Assessment
- timeFrame
- At Week 4
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with Investigator Global Assessment ≥ 2 and Body Surface Area ≥ 2% 2. Females who are of child-bearing potential should be practicing highly-effective contraception methods throughout the study and for 28 days after the last dose of study drug; 3. Male subjects with a mechanical contraceptive method; 4. be in good health 5. be willing to have skin biopsies taken Exclusion Criteria: 1. Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs to be respected 2. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit; 3. A positive serology test for hepatitis B, hepatitis C, HIV; 4. History of lymphoproliferative disease or of malignancy within the past 5 years. 5. Chronic recurring bacterial infections or active tuberculosis; 6. Positive pregnancy test at Screening and at the Baseline visit; 7. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; 8. History of clinically significant alcohol or drug abuse in the last 12 months 9. Known hypersensitivity to Deucravacitinib or any of its excipients 10. Current severe progressive or uncontrolled disease 11. Live vaccine within 12 weeks before Baseline Visit.
References
Publications (0)
Data not yet available