TYK2 Inhibition in Paradoxical Psoriasis (TYPP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Franziska Stuber, RN; Phone Number: +41 21 3143427; Email: franziska.stuber@chuv.ch

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois (Chuv)
      • Contact: Franziska Stuber, RN; Phone Number: +41 21 3143427; Email: franziska.stuber@chuv.ch
      • Principal Investigator: Curdin Conrad, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 'Deucravacitinib'; Deucravacitinib 6mg oral intake once daily for 4 weeks	Drug: Deucravacitinib; Daily drug intake for 4 weeks.
Placebo Comparator: 'Placebo'; Matching Placebo oral intake once daily for 4 weeks	Drug: Deucravacitinib; Daily drug intake for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paradoxical Psoriasis Body Surface Area	Change of Paradoxical Psoriasis Body Surface Area ( PxP-BSA )	At Week 4
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nanostring	Normalization of inflammatory gene signature	At Week 4

Collaborators and Investigators

• Sponsor: Prof Curdin Conrad
• Collaborators: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Curdin Conrad, Professor, CHUV centre hospitalier universitaire vaudois

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; anti-TNF treatment; Tumor necrosis factor inhibitors; Drug-induced Psoriasis; Paradoxical Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: IM011-1118; KOFAM 2023-01731 (Other Identifier: CER-VD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No