TYK2 Inhibition in Paradoxical Psoriasis

NCT06281106 | Terminated Phase 2

• 2 other identifiers: IM011-1118KOFAM 2023-01731
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Drug-induced Psoriasis; anti-TNF treatment; Psoriasis; Tumor necrosis factor inhibitors; Paradoxical Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Paradoxical Psoriasis Body Surface Area

  At Week 4

• Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index

  at 4 Weeks

• Paradoxical Psoriasis Scalp Investigator General Assessment

  At Week 4

• Psoriasis Area and Severity Index (PASI)

  At Week 4 and at Week 16

• American College of Rheumatology (ACR) Score

  At Week 4 and Week 16

Other Outcomes (1)

• Nanostring

  At Week 4

Study Arms (2)

'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

Deucravacitinib DRUG

Daily drug intake for 4 weeks.

'Deucravacitinib'; 'Placebo'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof Curdin Conrad: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Curdin Conrad, Professor

  CHUV centre hospitalier universitaire vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Lab personnel
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: June 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)