Clinical Trials List
2025-11-01 - 2027-10-11
Phase I/II
Recruiting4
ICD-10M32.0
Drug-induced systemic lupus erythematosus
ICD-10M32.10
Systemic lupus erythematosus, organ or system involvement unspecified
ICD-10M32.11
Endocarditis in systemic lupus erythematosus
ICD-10M32.12
Pericarditis in systemic lupus erythematosus
ICD-10M32.13
Lung involvement in systemic lupus erythematosus
ICD-10M32.14
Glomerular disease in systemic lupus erythematosus
ICD-10M32.15
Tubulo-interstitial nephropathy in systemic lupus erythematosus
ICD-10M32.19
Other organ or system involvement in systemic lupus erythematosus
ICD-10M32.8
Other forms of systemic lupus erythematosus
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-9710.0
Systemic lupus erythematosus
A randomized, double-blind, phase 1/2a trial was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DB-2304 injection in healthy adult participants and participants with systemic lupus erythematosus or cutaneous lupus erythematosus.
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Parexel International Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/03
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- 張哲慈 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2. Participants are willing and able to follow the prescribed treatment and evaluation protocol.
3. Male or female participants, aged 18 to 70 years old (inclusive) on the day of signing the ICF.
4. Currently receiving stable SLE/CLE treatment with any medication for at least one month prior to randomization.
SLE Participants: 4. Meet the 2019 SLE classification criteria of the European Union of Rheumatology Societies (EULAR)/American College of Rheumatology (ACR).
5. Positive for antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies at screening or have a history of such antibodies.
6. Have active lupus cutaneous disease or active arthritis, as defined by the SELENA-SLEDAI criteria at the time of screening and randomization.
CLE participants: Must be diagnosed with histologically confirmed CLE (past or at screening), with or without systemic LE manifestations.
7. Having active CLE despite receiving adequate conventional treatment.
Note: Other inclusion criteria specified in the program may apply.
Exclusion Criteria
2. Active neuropsychiatric SLE within 8 weeks prior to screening.
3. Any active skin condition or active arthritis other than CLE and SLE at the time of screening that may interfere with the assessment of skin or arthritis (e.g., tinea, non-LE skin lesions, non-LE alopecia areata, drug-induced lupus, rheumatoid arthritis).
4. A persistent malignancy or history thereof, including solid tumors and hematologic malignancies; exceptions are basal cell carcinoma and squamous cell carcinoma and cervical carcinoma in situ that have been completely removed and considered cured for >2 years prior to screening.
5. A known history of primary immunodeficiency (e.g., common variant immunodeficiency syndrome), splenectomy, or any basal condition that makes the participant susceptible to infection.
Note: Other exclusion criteria specified in the program may apply.
The Estimated Number of Participants
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Taiwan
7 participants
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Global
68 participants
