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Trial Title:
TYK2 Inhibition in Paradoxical Psoriasis
NCT ID:
NCT06281106
Condition:
Psoriasis
Conditions: Official terms:
Psoriasis
Deucravacitinib
Conditions: Keywords:
Drug-induced Psoriasis
anti-TNF treatment
Psoriasis
Tumor necrosis factor inhibitors
Paradoxical Psoriasis
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
During 4 weeks the patients of the 2 arms receive either Deucravacitinib 6mg 1x/day or an
identically looking placebo.
At Week 4, Patients with underlying disease of Crohn's disease, colitis ulcerosa, uveitis
will stop the study, to avoid that they are too long without efficient treatment for
their underlying disease.
Patients with underlying disease of psoriasis or psoriatic arthritis will have the
possiblity to continue in Part 2, where they all will receive Deucravacitinib 6mg 1x/day,
open label for 3 months
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Lab personnel
Intervention:
Intervention type:
Drug
Intervention name:
Deucravacitinib
Description:
Daily drug intake for 4 weeks.
Arm group label:
'Deucravacitinib'
Arm group label:
'Placebo'
Summary:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre hospitalier universitaire vaudois (CHUV)
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Contact:
Last name:
Franziska Stuber, RN
Phone:
+41 21 3143427
Email:
franziska.stuber@chuv.ch
Investigator:
Last name:
Curdin Conrad, Professor
Email:
Principal Investigator
Start date:
April 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Prof Curdin Conrad
Agency class:
Other
Collaborator:
Agency:
Centre Hospitalier Universitaire Vaudois
Agency class:
Other
Source:
Centre Hospitalier Universitaire Vaudois
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281106
