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New treatment option for Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
Official title A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
ClinicalTrials.gov ID: NCT06625671
What this study is testing
What is DB-2304?
DB-2304 is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle) or cutaneous lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- (Part A):
- Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent...
- Healthy male or female participants; 18 to 55 years of age (both inclusive) on the day of signing ICF; meet the body mass index (BMI) criteria.
- Based on the investigator assessment, there are no abnormal findings or findings with clinical significance from the medical history consultation...
- Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.
You likely can't join if
- (Part A):
- Evidence or history of clinically significant diseases.
- History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).
- Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.
- History of sensitivity to any ingredients of DB-2304.
- Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study. Exclusion Criteria (Part B):
See the full eligibility criteria
- (Part A):
- Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate.
- Healthy male or female participants; 18 to 55 years of age (both inclusive) on the day of signing ICF; meet the body mass index (BMI) criteria.
- Based on the investigator assessment, there are no abnormal findings or findings with clinical significance from the medical history consultation, physical examination, vital signs assessment, clinical laboratory tests...
- Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.
- Participants who are willing and able to comply with the prescribed protocol treatment and evaluations (Part B):
- Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate.
- Participants who are willing and able to comply with the prescribed protocol treatment and evaluations.
- Male or female participants, 18 to 70 years of age (both inclusive) on the day of signing ICF.
- Currently receiving a stable SLE/CLE treatment regimen of any medication for a period of at least 1 month prior to randomization. For SLE： 4. Meet the European Alliance of Associations for Rheumatology (EULAR)/American...
- (Part A):
- Evidence or history of clinically significant diseases.
- History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).
- Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.
- History of sensitivity to any ingredients of DB-2304.
- Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study. Exclusion Criteria (Part B):
- Have active lupus nephritis or moderate-to-severe or chronic kidney disease
- Have active neuropsychiatric SLE within 8 weeks prior to screening
- Any active skin conditions or active arthritis other than SLE that may interfere with skin or arthritis assessments (e.g., psoriasis, non-LE skin lesions, non-LE alopecia areata, drug-induced lupus, rheumatoid...
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies with the exception of basal cell carcinomas and squamous cell carcinomas and carcinoma in situ of the cervix that have been...
- Known history of a primary immunodeficiency (e.g., common variable immunodeficiency syndrome), splenectomy, or any underlying condition that predisposes the participant to infection. NOTE: Other protocol defined...
The study team makes the final eligibility decision.
Where it's taking place
- La Palma, California, United States
- Clearwater, Florida, United States
- Orlando, Florida, United States
- Syracuse, New York, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Melbourne, Victoria, Australia
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, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Palma, California, United States; Clearwater, Florida, United States; Orlando, Florida, United States; Syracuse, New York, United States; Irving, Texas, United States; San Antonio, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.