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Clinical Trials/2023-503776-25-00
2023-503776-25-00
Active, not recruiting
Phase 4

AN INVESTIGATOR-INITIATED, PHASE 4, OPEN-LABEL, SINGLE-ARM, SINGLE-CENTER STUDY INVESTIGATING THE TISSUE-RESIDENT MEMORY T-CELLS AND DISEASE MEMORY IN PSORIASIS SKIN DURING GUSELKUMAB TREATMENT. THE GUSMEM STUDY.

Aarhus University Hospital1 site in 1 country15 target enrollmentStarted: April 28, 2023Last updated:
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Overview

Phase
Phase 4
Status
Active, not recruiting
Sponsor
Aarhus University Hospital
Enrollment
15
Locations
1
Primary Endpoint
Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The main aim of the project is to investigate whether guselkumab treatment can change the quantity of TRMs in the skin as well as change the protein expression in the microenvironment around these cells in psoriasis patients.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •History of plaque psoriasis.
  • •One target lesion of ~4 cm at its longest axis located on the body (except for the scalp, face, or intertriginous areas), scoring at least 1 for each of redness, thickness, and scaliness on the target plaque severity score (TPSS).
  • •Women involved in any sexual intercourse that could lead to pregnancy must agree to use a highly effective contraceptive method from at least 4 weeks before baseline (visit 2). Effective contraceptive methods are: Systemic hormonal contraceptives (oral contraceptive, transdermal patches, vaginal rings, long-acting injectables, or implants), intrauterine devices, vasectomy. This must be used until 12 weeks after EOT. Hormonal contraceptives must be on a stable dose for at least 4 weeks before baseline (visit 2). Women of nonchildbearing potential are as follows: i. Women ≥60 years of age. ii. Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation) iii. Women >40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (FSH ≥40 mIU/mL) or cessation of menses for at least 24 months without FSH levels confirmed. A negative serum pregnancy test at screening and a negative urine pregnancy test at baseline (visit 2) must be presented by women of childbearing potential.

Exclusion Criteria

  • •History or presence of signs or symptom of progressive or uncontrollable infectious, endocrine, neurological, renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, hematological rheumatological, psychiatric or metabolic disturbance and/or abnormal blood test or vital signs other paraclinical information, including disorders of calcium metabolism, that, in the opinion of the investigator, may expose the patient to elevated or unnecessary risk or interfere with the interpretation of results.
  • •A history of malignancies within the past five years (excluding localized nonmelanoma skin cancer).
  • •Known hypersensitivity to any ingredient in the IMP or to components of the container.
  • •Participant has had, or is planning, a major surgery within 8 weeks prior to baseline (except minor minimally invasive procedures).
  • •Participant has a contraindication to skin biopsies.
  • •Participant is currently receiving an investigational product or device or has received one within 4 weeks prior to baseline, that in the opinion of the investigator, might interfere with the results.
  • •Participant has used biologic medication 12 weeks prior to baseline visit (Day 0), or 5 half-lives (whichever is longer).
  • •Use of any systemic treatment for psoriasis (such as methotrexate, immunosuppressive drugs, corticosteroids, azathioprine, or cyclosporine) within 4 weeks prior to baseline and during the study.
  • •Use of any topical medication to treat psoriasis (including salicylic acid, retinoid, calcineurin inhibitors, corticosteroids, vitamin D analogue, or tar) within 2 weeks prior to baseline. Use of moisturizers and emollients are not exclusion criteria.
  • •Participant had psoralen and ultraviolet A or narrowband ultraviolet B treatment within 4 weeks prior to baseline.

Outcomes

Primary Outcomes

Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103.

Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103.

Change in the number of TRMs in the epidermis and dermis between baseline and EOT using IHC. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD103.

Change in the number of TRMs in the epidermis and dermis between baseline and EOT using IHC. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD103.

Secondary Outcomes

  • Change in CD11c+ Dendritic cells over the study duration.
  • Change in CD163+ Macrophages over the study duration.
  • Change in Langerin+/CD207+ Langerhans-cells over the study duration.
  • Change in Myeloperoxidase+ Neutrophils over the study duration.
  • Change in CD4+/FOXP3+ single and double positive cells over the study duration.
  • Change in CD103/RORγt single and double positive cells over the study duration.
  • Change in CD3+, CD4+, CD8+, CD49a+, CD69+, and CD103+ multiple, or single positive cells over the study duration.
  • Change in proliferation assessed using Ki67+ staining over the study duration.
  • Change in epidermal thickness over the study duration.

Investigators

Sponsor
Aarhus University Hospital
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Christian Vestergaard

Scientific

Aarhus University Hospital

Study Sites (1)

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