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Investigation of tissue-resident memory T-cells and disease MEMory in psoriasis during GUSelkumab treatment. The GUSMEM study.
EU CTIS ID: 2023-503776-25-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Age <18.
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Age <18.
- 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.
- Female participant who is breastfeeding, pregnant, or who is planning pregnancy during the study period.
- Participant has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
- History of keloid formation or hypertrophic scarring in suture sites or scars.
- Known inability or unavailability of a participant to complete required study visits during study participation including any condition associated with poor compliance as judged by the investigator.
- History of intravenous drug use.
- A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the participant’s medical history, which, in the opinion of the investigator, may obstruct compliance.
- Participant protected by the law (adult under guardianship or hospitalized in a public or private institution for a reason other than study, or incarcerated).
- Mental or linguistic incapacity to sign the consent form.
- History of concomitant skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments and the acquisition of biopsies.
- Infectious skin lesions on treated areas (e.g., herpes, varicella, fungal, bacterial, and parasitic skin infections, skin manifestations in relation to tuberculosis).
- Treated skin must not be affected by perioral dermatitis, striae atrophicae, atrophic skin, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.
- Active or latent tuberculosis requiring treatment.
- History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject’s verbal report.
- No history of varicella zoster infection and negative varicella antibody test (until varicella vaccination is completed), positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening.
- Other psoriasis subtype that according to investigator may influence any assessments (erythrodermic, guttate, pustular, inverse, drug-induced).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.