A Phase 2 interventional study of Placebo in Cutaneous Lupus Erythematosus (CLE), sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (part of 3SBio Inc.) · Phase 2, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of subcutaneous (SC) 626 versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy and safety of subcutaneous 626 injections for treating CLE, while also assessing the PK, immunogenicity, and PD characteristics of 626 in CLE participants to inform Phase III dose selection.
The study plans to include about 140 CLE participants. Eligible participants will be stratified and randomized based on baseline CLE severity (CLASI-A score ≥10 and CLASI-A score \<10) and CLE clinical subtype (DLE subtype and non-DLE subtype) in a 1:1:1:1 ratio to the study drug A group , study drug B group, study drug C group and placebo group, with about 35 participants in each group.
67 studies on the registry are indexed under Lupus Erythematosus, Cutaneous; 18 are open to participants now.
This study's planned enrollment of 140 is above the median of 32 across 57 interventional studies indexed under Lupus Erythematosus, Cutaneous.
Browse Lupus Erythematosus, Cutaneous studies →Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 59 studies on the registry; 22 are open to participants now.
First submitted after Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. became part of 3SBio Inc..
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
626 Dose A subcutaneous (SC) injection
Drug: Placebo
626 Dose B subcutaneous (SC) injection
Drug: Placebo
626 Dose C subcutaneous (SC) injection
Drug: Placebo
Placebo subcutaneous (SC) injection
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 24
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity
Time frame: Baseline to Week 24
CLASI-70
Proportion of participants achieving ≥70% improvement from baseline in CLASI-A score at each efficacy assessment visit.
Time frame: Baseline to Week 56
CLASI-50
Proportion of participants achieving ≥50% improvement from baseline in CLASI-A score at each efficacy assessment visit
Time frame: Baseline to Week 56
CLASI ≥7
Proportion of participants with a reduction of ≥7 points from baseline in CLASI-A score at each efficacy assessment visit.
Time frame: Baseline to Week 56
CLA-IGA-R erythema
Proportion of participants with baseline CLA-IGA-R erythema score of ≥3 who achieve a CLA-IGA-R erythema score of 0 or 1 at each efficacy assessment visit.
Time frame: Baseline to Week 56
CLA-IGA-R OMC
Proportion of participants achieving a CLA-IGA-R OMC score of 0 or 1 with a reduction of ≥1 point from baseline at each efficacy assessment visit.
Time frame: Baseline to Week 56
SLEDAI-2K
Change from baseline in SLEDAI-2K score at each efficacy assessment visit among participants with SLE.
Time frame: Baseline to Week 56
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Cutaneous →
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. →