TYK2 Inhibition in Paradoxical Psoriasis (TYPP)

March 27, 2025 updated by: Prof Curdin Conrad

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Paradoxical Psoriasis Investigator Global Assessment
Time Frame: At Week 4
Percentage of patients attaining PxP IGA 0/1 and at least a reduction of 2 points from baseline
At Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Paradoxical Psoriasis Body Surface Area
Time Frame: 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.
At Week 4
Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index
Time Frame: 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.
at 4 Weeks
Paradoxical Psoriasis Scalp Investigator General Assessment
Time Frame: 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.
At Week 4
Psoriasis Area and Severity Index (PASI)
Time Frame: 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.
At Week 4 and at Week 16
American College of Rheumatology (ACR) Score
Time Frame: 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
At Week 4 and Week 16

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nanostring
Time Frame: At Week 4
Normalization of inflammatory gene signature
At Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof Curdin Conrad

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier Universitaire Vaudois

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Curdin Conrad, Professor, CHUV Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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