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NCT07900867
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Conditions: Cutaneous Lupus Erythematosus (CLE)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 140
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Location: Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College. Nanjing Jiangsusheng
Summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) 626 versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
Eligibility Criteria
Key Inclusion Criteria:
1. Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed,with or without SLE manifestations.
2. CLASI-A total score ≥ 8 points at Screening and confirmed at randomization.
3. Inadequate response or intolerant to antimalarial therapy.
4. Currently receiving at least one of the SoC CLE medications.
Key Exclusion Criteria:
1. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
2. Active lupus nephritis or moderate-to-severe or chronic kidney disease.
3. Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition
4. History of chronic, recurrent (3 or more of the same type of infection in a 12-month period).
5. Has a history of severe herpes infection
Source: ClinicalTrials.gov (NCT07900867). StuddyBuddy aggregates publicly available trial information.