Clinical trial NCT06281106: TYK2 Inhibition in Paradoxical Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Psoriasis
Keywords: Drug-induced Psoriasis
anti-TNF treatment
Psoriasis
Tumor necrosis factor inhibitors
Paradoxical Psoriasis
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2024-02-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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.

Primary outcomes:
measure: Paradoxical Psoriasis Investigator Global Assessment
timeFrame: At Week 4
Secondary outcomes:
measure: Paradoxical Psoriasis Body Surface Area
timeFrame: At Week 4
measure: Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index
timeFrame: at 4 Weeks
measure: Paradoxical Psoriasis Scalp Investigator General Assessment
timeFrame: At Week 4
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: At Week 4 and at Week 16
measure: American College of Rheumatology (ACR) Score
timeFrame: At Week 4 and Week 16
Other outcomes:
measure: Nanostring
timeFrame: At Week 4
Locations:
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
state: VD
Study officials:
affiliation: CHUV centre hospitalier universitaire vaudois
name: Curdin Conrad, Professor
role: PRINCIPAL_INVESTIGATOR
References: