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TYK2 Inhibition in Paradoxical Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06281106
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Prof Curdin Conrad
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Curdin Conrad, Professor
Principal Investigator Affiliation CHUV centre hospitalier universitaire vaudois
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Arms & Interventions

Arms

Active Comparator: 'Deucravacitinib'

Deucravacitinib 6mg oral intake once daily for 4 weeks

Placebo Comparator: 'Placebo'

Matching Placebo oral intake once daily for 4 weeks

Interventions

Drug: - Deucravacitinib

Daily drug intake for 4 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Lausanne, VD, Switzerland

Status

Address

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, VD, 1011

Site Contact

Franziska Stuber, RN

franziska.stuber@chuv.ch

+41 21 3143427

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