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PsoriasisPhase 2/3TYPPNCT06281106

TYK2 Inhibition in Paradoxical Psoriasis

A Phase 2/3 study testing Deucravacitinib in people with Psoriasis, run by Prof Curdin Conrad at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Deucravacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteSwitzerland
Study dates
20 Jun 2024to 20 Mar 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre hospitalier universitaire vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Psoriasis
Being tested
Deucravacitinib
Keywords
Drug-induced Psoriasis, anti-TNF treatment, Psoriasis, Tumor necrosis factor inhibitors, Paradoxical Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeucravacitinibDrug

    Daily drug intake for 4 weeks.

Study groups in NCT06281106
Study groupRoleWhat they receive
'Deucravacitinib'Active comparatorDeucravacitinib 6mg oral intake once daily for 4 weeks
Receives: Drug: Deucravacitinib
'Placebo'Placebo comparatorMatching Placebo oral intake once daily for 4 weeks
Receives: Drug: Deucravacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paradoxical Psoriasis Investigator Global Assessment

    Percentage of patients attaining PxP IGA 0/1 and at least a reduction of 2 points from baseline

    Measured: At Week 4

Secondary outcomes (5)

  1. 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.

    Measured: At Week 4

  2. Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index

    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.

    Measured: at 4 Weeks

  3. Paradoxical Psoriasis Scalp Investigator General Assessment

    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.

    Measured: At Week 4

  4. Psoriasis Area and Severity Index (PASI)

    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.

    Measured: At Week 4 and at Week 16

  5. American College of Rheumatology (ACR) Score

    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

    Measured: At Week 4 and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start20 Jun 2024
  3. Primary completion20 Mar 2025
  4. Study completion20 Mar 2025

Why it stopped: External research funds were canceled, so study could unforunately not be continued

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06281106
Sponsor's protocol ID
IM011-1118
Other IDs
KOFAM 2023-01731
Acronym
TYPP
Status last verified
Mar 2025
First submitted
20 Feb 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Deucravacitinib in people with Psoriasis, run by Prof Curdin Conrad at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: External research funds were canceled, so study could unforunately not be continued). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paradoxical Psoriasis Investigator Global Assessment (time frame: At Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06281106.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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