TYK2 Inhibition in Paradoxical Psoriasis | NCT06281106

Studies
TYK2 Inhibition in Paradoxical Psoriasis

NCT06281106

Sponsor

Prof Curdin Conrad

Status

Terminated

Last Update Posted

Apr 2, 2025Actual

Enrollment

2Actual

Phase

Phase 2Phase 3

Conditions

Psoriasis

Interventions

Deucravacitinib

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KOFAM 2023-01731	Other Identifier	CER-VD

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

External research funds were canceled, so study could unforunately not be continued

Expanded Access Info

Start Date

Jun 20, 2024Actual

Primary Completion Date

Mar 20, 2025Actual

Completion Date

Mar 20, 2025Actual

First Submitted Date

Feb 20, 2024

First Submission Date that Met QC Criteria

Feb 20, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 2, 2025Actual

Name	Class
Centre Hospitalier Universitaire Vaudois	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
'Deucravacitinib'	Active Comparator	Deucravacitinib 6mg oral intake once daily for 4 weeks	Drug: Deucravacitinib
'Placebo'	Placebo Comparator	Matching Placebo oral intake once daily for 4 weeks	Drug: Deucravacitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deucravacitinib	Drug	Daily drug intake for 4 weeks.	'Deucravacitinib' 'Placebo'

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Paradoxical Psoriasis Body Surface Area	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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with Investigator Global Assessment ≥ 2 and Body Surface Area ≥ 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;
Male subjects with a mechanical contraceptive method;
be in good health
be willing to have skin biopsies taken

Exclusion Criteria:

Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs to be respected
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;
A positive serology test for hepatitis B, hepatitis C, HIV;
History of lymphoproliferative disease or of malignancy within the past 5 years.
Chronic recurring bacterial infections or active tuberculosis;
Positive pregnancy test at Screening and at the Baseline visit;
Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
History of clinically significant alcohol or drug abuse in the last 12 months
Known hypersensitivity to Deucravacitinib or any of its excipients
Current severe progressive or uncontrolled disease
Live vaccine within 12 weeks before Baseline Visit.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Curdin Conrad, Professor	CHUV centre hospitalier universitaire vaudois	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier universitaire vaudois (CHUV)		Lausanne	Canton of Vaud	1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D011565	Psoriasis

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C000628674	deucravacitinib

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