Trial · NCT07900867
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
NCT07900867, Phase 2, Not yet recruiting, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE. Trials, record NCT07900867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
- NCT number
- NCT07900867
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Interventions
- Placebo
- First posted
- 2026-10-28
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 24 | Baseline 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 |
| Secondary | CLASI-70 | Baseline to Week 56 | Proportion of participants achieving ≥70% improvement from baseline in CLASI-A score at each efficacy assessment visit. |
| Secondary | CLASI-50 | Baseline to Week 56 | Proportion of participants achieving ≥50% improvement from baseline in CLASI-A score at each efficacy assessment visit |
| Secondary | CLASI ≥7 | Baseline to Week 56 | Proportion of participants with a reduction of ≥7 points from baseline in CLASI-A score at each efficacy assessment visit. |
| Secondary | CLA-IGA-R erythema | Baseline to Week 56 | 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. |
| Secondary | CLA-IGA-R OMC | Baseline to Week 56 | 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. |
| Secondary | SLEDAI-2K | Baseline to Week 56 | Change from baseline in SLEDAI-2K score at each efficacy assessment visit among participants with SLE. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900867
GET https://conductscience.org/api/trials/v1/NCT07900867/registered