Psoriasis
Conditions
Keywords
Drug-induced Psoriasis, anti-TNF treatment, Psoriasis, Tumor necrosis factor inhibitors, Paradoxical Psoriasis
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.
Interventions
DRUGDeucravacitinib
Daily drug intake for 4 weeks.
Sponsors
Centre Hospitalier Universitaire Vaudois
Prof Curdin Conrad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Lab personnel
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paradoxical Psoriasis Investigator Global Assessment | At Week 4 | Percentage of patients attaining PxP IGA 0/1 and at least a reduction of 2 points from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paradoxical Psoriasis Body Surface Area | At Week 4 | Change of Paradoxical Psoriasis Body Surface Area ( PxP-BSA ) measured in percentage of the total Body Surface area. 100% would be the total Body Surface area. |
| Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index | at 4 Weeks | Change of Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index (PxP PPPASI) Score in patients presenting paradoxical psoriasis of the hands of feet. Where 72 is the worst possible calculated score, and 0 is the best score. |
| Psoriasis Area and Severity Index (PASI) | At Week 4 and at Week 16 | Change of Psoriasis Area and Severity Index (PASI) in patients with pre-existing disease of Psoriasis. The PASI is calculated following the official PASI Score calculation. 72 is the worst score, 0 means clear skin. |
| American College of Rheumatology (ACR) Score | At Week 4 and Week 16 | Percentage of patients with underlying disease of psoriasic arthritis, having an American College of Rheumatology (ACR) Score of 20%, 50% or 70% reduction in comparison with the Baseline assessment. To achive a 70% ACR, an improvement of 70% in the number of painful joints, and in the number of swollen joints must be reached, additionally an improvement of 70% in 3 out of 5 criteria need to be reached: Health Assessment Questionnaire, assessing patients disability (0 best score, 3 worst score), Patient overall disease assessement (0 no disease activity, 10 worst disease activity), Visual Analogue Scale assessing patients pain (0 no pain, 10 worst pain), C-reactive protein Blood-Test (CRP); Investigator General Disease Activity Assessment (0 no disease activity, 10 worst disease activity) For ACR 50%, the same calculation is made with 50% improvement, ACR 20%, same calculation with 20% improvement |
| Paradoxical Psoriasis Scalp Investigator General Assessment | At Week 4 | Change of Paradoxical Psoriasis Scalp Investigator General Assessment (PxP-scalp IGA) if paradoxical Psoriasis is affecting the Scalp. It's a 4-point Scale with 4 being the worst score (severe Scalp Psoriasis) and 0 is the best score with clear scalp. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nanostring | At Week 4 | Normalization of inflammatory gene signature |
Countries
Switzerland
Outcome results
None listed