Immunological and functional characteristics of T memory-like cells in psoriasis under treatment with deucravacitinib.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Charite Universitaetsmedizin Berlin KöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

completed 5 May 2025

Decision date (initial)

2024-09-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-510759-37-00

WHO UTN

U1111-1308-8555

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

This is an exploratory study analyzing the effects of TYK-2 inhibition (TYK-2i) on TRM-like cells.

Secondary objectives 1

1. To assess the relationship between the reduction in inflammatory and infiltrating cells and cytokines following TYK-2 inhibition with Sotyktu® and the potential impact on TRM-like cell dynamics.

Conditions and MedDRA coding

Plaque Psoriasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patients must be planned to be initiated on Sotyktu® in routine clinical care
2. Patients with psoriasis less than 5 years since onset
3. Subjects must be willing to participate in the study
4. able to understand the patient information
5. and sign the informed consent form
6. all sexes
7. Age ≥18 years
8. The patient has moderate to severe psoriasis as defined by the German S3 guideline, characterized by: a. Body-surface area (BSA) of 10% or more and Dermatological Life Quality Index (DLQI) score of 10 or higher, OR b. Psoriasis Area and Severity Index (PASI) score of 10 or higher and Dermatological Life Quality Index (DLQI) score of 10 or higher, OR c. Meeting any of the following upgrade criteria according to the German S3 guidelines for systemic treatment: i. Severe disease in visual areas, ii. Severe disease of the scalp, iii. Genital psoriasis, iv. Palmoplantar psoriasis, v. Onycholysis or onychodystrophy of at least 2 fingernails, vi. Experience pruritus and associated itching, vii. Therapy-resistant plaques.

Exclusion criteria 20

1. Participation in any other clinical trial or treatment with investigational medicinal products (IMPs) or previous therapies with known or potential overlapping toxicities with the IMP and its relevant metabolites, within a period equivalent to five times the half-life of the IMP or its relevant metabolites (whichever is longer) prior to screening.
2. Pustular Psoriasis
3. History of lymphoproliferative disorders.
4. Leukopenia a. absolute WBC count < 3000/mm3 b. Lymphopenia (ALC < 500/mm3) c. Neutropenia (ANC < 1000/mm3) d. Thrombocytopenia (platelet count < 100,000/mm3)
5. Patients who are considered potentially unreliable or may not consistently attend scheduled study visits.
6. Inability or unwillingness to undergo repeated venepuncture (e.g., because of poor tolerability or lack of access to veins).
7. Patients with prior exposure to deucravacitinib or other JAK-inhibitor.
8. Patients with prior exposure to more than one biologic.
9. Pregnant or breastfeeding women
10. Patients with prior exposure to systemic treatments targeting IL-23 or IL-12.
11. Patients receiving biologics (IL-17) within 3 months of first administration of Sotyktu® at V1 (baseline).
12. Patients receiving biologics (TNF-α) within 1 months of first administration of Sotyktu® at V1 (baseline).
13. Patients receiving any systemic immunosuppressants (eg, MTX, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) or anakinra within 4 weeks of the first administration of Sotyktu® at V1 (baseline).
14. Patients receiving phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of Sotyktu® after V1 (baseline).Patients receiving topical medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, pimecrolimus, apremilast and tacrolimus) within 1 week of the first administration of Sotyktu® at V1 (baseline).
15. History of allergy to any component of Sotyktu ®
16. Subjects deprived of freedrom i.e., detainment or commitment to psychiatric ward, prison or state institution by law court or legal authority
17. Permanent severe diseases, especially those affecting the immune system other than psoriasis, such as: a. Systemic lupus erythematodes, b. autoimmune blistering diseases (AIBD), c. myasthenia gravis, d. multiple sclerosis, e. seropositive rheumatoid arthritis, f. Crohn´s disease, g. ulcerative colitis
18. Female subjects of childbearing potential who are not using a highly effective method of contraception as recommended by the “CTCG Recommendations related to contraception and pregnancy testing in clinical trials, Version 1.2."
19. Subjects who are unwilling or unable to comply with the pregnancy testing requirements during the study period
20. Contraindications to Deucravacitinib: a. Known hypersensitivity to Deucravacitinib or any of its excipients, b. Active tuberculosis, untreated latent tuberculosis, or serious chronic infections, c. Active or chronic hepatitis B or C, or HIV infection, d. Severe hepatic impairment, e. Severe renal impairment (glomerular filtration rate <30 mL/min), f. History of malignancies, including lymphoproliferative disorders, except successfully treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, g. Use of live vaccines within 4 weeks prior to baseline or planned during the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. This is an explorative study which aims to analyze the impact of TYK-2i on TRM-like cells. To specifically evaluate the impact of TYK-2 inhibition with deucravacitinib on TRM-like CD4+-IL17A producing T cells, both quantitatively and in terms of functional activity, after 24 weeks of treatment.

Secondary endpoints 1

1. To assess the correlation between the reduction in inflammatory infiltrating cells and cytokines (specifically IL-17/IL-22/IL-23) following TYK-2 inhibition with deucravacitinib and the potential impact on TRM-like cell dynamics. This

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Charite Universitaetsmedizin Berlin KöR

Sponsor organisation

Charite Universitaetsmedizin Berlin KöR

Address

Chariteplatz 1, Mitte Mitte

City

Berlin

Postcode

10117

Country

Germany

Scientific contact point

Organisation

Charite Universitaetsmedizin Berlin KöR

Contact name

Dr. Franz J. Hilke

Public contact point

Organisation

Charite Universitaetsmedizin Berlin KöR

Contact name

Dr. Franz J. Hilke

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications