TYK2 Inhibition in Paradoxical Psoriasis (TYPP)

Prof Curdin Conrad

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Psoriasis

Treatments: Drug: Deucravacitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06281106

KOFAM 2023-01731 (Other Identifier)

IM011-1118

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups, including a placebo group

'Deucravacitinib'

Active Comparator group

Description:

Deucravacitinib 6mg oral intake once daily for 4 weeks

Treatment:

Drug: Deucravacitinib

'Placebo'

Placebo Comparator group

Description:

Matching Placebo oral intake once daily for 4 weeks

Treatment:

Drug: Deucravacitinib