TYK2 Inhibition in Paradoxical Psoriasis

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

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NCT-Nummer:
NCT06281106

Studienbeginn:
April 2024

Letztes Update:
28.02.2024

Wirkstoff:
Deucravacitinib

Indikation (Clinical Trials):
Psoriasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Prof Curdin Conrad

Collaborator:
Centre Hospitalier Universitaire Vaudois

Studienleiter

Curdin Conrad, Professor
Principal Investigator
CHUV centre hospitalier universitaire vaudois

Kontakt

Franziska Stuber, RN
Kontakt:
Phone: +41 21 3143427
E-Mail: franziska.stuber@chuv.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Centre hospitalier universitaire vaudois (CHUV)
1011 Lausanne
Switzerland» Google-Maps
Ansprechpartner:
Franziska Stuber, RN
Phone: +41 21 3143427
E-Mail: franziska.stuber@chuv.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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

Secondary outcome:

1. Paradoxical Psoriasis Body Surface Area (Time Frame - At Week 4):
Change of Paradoxical Psoriasis Body Surface Area ( PxP-BSA )

2. 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

3. 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

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

5. 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 comparion with the Baseline assessment.

Studien-Arme

Active Comparator: 'Deucravacitinib'
Deucravacitinib 6mg oral intake once daily for 4 weeks
Placebo Comparator: 'Placebo'
Matching Placebo oral intake once daily for 4 weeks

Geprüfte Regime

Deucravacitinib:
Daily drug intake for 4 weeks.

Quelle: ClinicalTrials.gov

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