Actively Recruiting
Deep Phenotyping of Cutaneous Lupus Erythematosus
Led by Centre for Human Drug Research, Netherlands · Updated on 2024-05-13
40
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cutaneous lupus erythematosus (CLE) is an autoimmune disease of which the pathogenesis and pathophysiology are not fully understood. Given the complex and heterogeneous character of the disease, identification, and development of specific biomarkers for diagnosis, disease subtyping, disease severity, and treatment response in CLE is challenging. Therefore, the main objective of the current study is to further characterize CLE by using a deep phenotyping approach. Moreover, the role of TLR7 activation in the pathophysiology of the various clinical subtypes of CLE will be specifically studied. With this approach the investigators aim to characterize objectively measured disease characteristics and detect novel biomarkers for CLE(-subtypes).
CONDITIONS
Official Title
Deep Phenotyping of Cutaneous Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedure
- Male or female aged 18 to 65 years at signing informed consent
- Stable good health based on medical history, physical exam, vital signs, ECG, and lab tests
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 for healthy volunteers, and up to 35.0 kg/m2 for CLE patients
- Fitzpatrick skin type I-III (Caucasian) for healthy volunteers and for CDLE patients in part B
- Effective contraception used by subjects and their partners of childbearing potential during the study
- Ability to communicate well in Dutch and willingness to comply with study requirements
- Willingness to avoid applying topical products on target skin lesions 24 hours before each study visit
- For CLE patients: diagnosis of SCLE, CDLE, or LET confirmed by clinicopathological correlation
- At least one CLE skin lesion of at least 3x3 cm suitable for study measurements
- Lesion location outside the face (e.g., neck, chest, back, limbs, scalp, ear)
- Stable use (minimum 8 weeks) of no systemic treatment or hydroxychloroquine
- CLE Disease Area and Severity Index Activity (CLASI-A) score of 3 or higher excluding alopecia or oral ulcers
You will not qualify if you...
- History of immunological abnormalities or immune suppression affecting study objectives
- Current or recurrent clinically significant skin conditions including tattoos for healthy volunteers
- Antibiotic use, surgery, or significant dental intervention within one month before Day 1
- Positive hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at screening
- Participation in another investigational drug study within 3 months prior or more than 4 times a year
- Blood loss or donation over 500mL within three months before screening
- Use of medications interfering with study within 28 days prior to Day 1
- History of alcohol abuse or consuming more than 5 standard drinks per day within 3 months
- Positive urine drug test or history of drug abuse
- Pregnancy, breastfeeding, or intending pregnancy during study
- Any clinically significant medical condition interfering with study conduct
- Previous use of Aldara (imiquimod cream) within 3 months before Day 1 in part B
- Any active, chronic, or uncontrolled condition affecting study conduct
- Skin infections or diseases other than CLE in target areas
- Recent treatments for CLE or other diseases within specified intervals prior to Day 1
- Severe lupus-associated kidney disease
- Presence of antiphospholipid syndrome
- Active or unstable lupus neuropsychiatric disease
- Severe or unstable systemic lupus manifestations
- Diagnosis of systemic lupus erythematosus or signs of systemic involvement (part B only)
- Low complement levels or positive autoantibodies at screening (part B only)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre for Human Drug Research
Leiden, South Holland, Netherlands, 2333CL
Actively Recruiting
Research Team
R
R. Rissmann, RPh, PhD
CONTACT
D
D. T. de Bruin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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