TYK2 Inhibition in Paradoxical Psoriasis

Psoriasis Clinical Trial

— TYPP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281106
• Other study ID #: IM011-1118
• Secondary ID: KOFAM 2023-01731
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2024
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Franziska Stuber, RN
• Phone: +41 21 3143427
• Email: franziska.stuber[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Deucravacitinib
Daily drug intake for 4 weeks.

Locations

Country	Name	City	State
Switzerland	Centre hospitalier universitaire vaudois (CHUV)	Lausanne	VD

Sponsors (2)

Lead Sponsor	Collaborator
Prof Curdin Conrad	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nanostring	Normalization of inflammatory gene signature	At Week 4
Primary	Paradoxical Psoriasis Investigator Global Assessment	Percentage of patients attaining PxP IGA 0/1 and at least a reduction of 2 points from baseline	At Week 4
Secondary	Paradoxical Psoriasis Body Surface Area	Change of Paradoxical Psoriasis Body Surface Area ( PxP-BSA )	At Week 4
Secondary	Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index	Change of Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index (PxP PPPASI) Score in patients presenting paradoxical psoriasis of the hands of feet	at 4 Weeks
Secondary	Paradoxical Psoriasis Scalp Investigator General Assessment	Change of Paradoxical Psoriasis Scalp Investigator General Assessment (PxP-scalp IGA) if paradoxical Psoriasis is affecting the Scalp	At Week 4
Secondary	Psoriasis Area and Severity Index (PASI)	Change of Psoriasis Area and Severity Index (PASI) in patients with pre-existing disease of Psoriasis	At Week 4 and at Week 16
Secondary	American College of Rheumatology (ACR) Score	Percentage of patients with underlying disease of psoriasic arthritis, having an American College of Rheumatology (ACR) Score of 20%, 50% or 70% reduction in comparion with the Baseline assessment.	At Week 4 and Week 16