NCT06281106TerminatedPhase 2/3
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 · Last updated 2 Apr 2025
Reason given: External research funds were canceled, so study could unforunately not be continued
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 20 Feb 2024
- Start date
- 20 Jun 2024
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- Prof Curdin Conrad
- Diseases
- Psoriasis
- NCT number
- NCT06281106
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs to be respected
- 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;
- Live vaccine within 12 weeks before Baseline Visit.
Other illness
- A positive serology test for hepatitis B, hepatitis C, HIV;
- History of lymphoproliferative disease or of malignancy within the past 5 years.
- Chronic recurring bacterial infections or active tuberculosis;
- History of clinically significant alcohol or drug abuse in the last 12 months
- Known hypersensitivity to Deucravacitinib or any of its excipients
- Current severe progressive or uncontrolled disease
Other
- Positive pregnancy test at Screening and at the Baseline visit;
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
Who the study is looking for
- Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with Investigator Global Assessment ≥ 2 and Body Surface Area ≥ 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;
- Male subjects with a mechanical contraceptive method;
- be in good health
- be willing to have skin biopsies taken
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.