Cutaneous Lupus Erythematosus (CLE)Phase 2NCT07900867
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
A Phase 2 study of Cutaneous Lupus Erythematosus (CLE), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 2 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) 626 versus placebo in adult participants with cutaneous lupus erythematosus (CLE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cutaneous Lupus Erythematosus (CLE)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed,with or without SLE manifestations.
- CLASI-A total score ≥ 8 points at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
- Currently receiving at least one of the SoC CLE medications.
Who cannot join
- Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
- Active lupus nephritis or moderate-to-severe or chronic kidney disease.
- 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
- History of chronic, recurrent (3 or more of the same type of infection in a 12-month period).
- Has a history of severe herpes infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking University First Hospital
Beijing
Zhuoli Zhang, 010-83572211, zhuoli.zhang@126.com
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College.
Nanjing, Jiangsusheng, jiangsusheng
Qianjin Lu, 025-85478084, qianlu5860@gmail.com
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of SSGJ-626 in Participants With Active Cutaneous Lupus Erythematosus
This study aims to evaluate the efficacy and safety of subcutaneous (SC) 626 versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
Read the detailed description
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 (626 200 mg Q4W), study drug B group (626 400 mg Q8W), study drug C group (626 400 mg Q4W), and placebo group, with about 35 participants in each group.
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Being tested
- Placebo
- Keywords
- BDCA2
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 626 Dose A subcutaneous (SC) injection Receives: Drug: Placebo |
| Group B | Experimental | 626 Dose B subcutaneous (SC) injection Receives: Drug: Placebo |
| Group C | Experimental | 626 Dose C subcutaneous (SC) injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 24
Secondary outcomes (6)
CLASI-70
Proportion of participants achieving ≥70% improvement from baseline in CLASI-A score at each efficacy assessment visit.
Measured: Baseline to Week 56
CLASI-50
Proportion of participants achieving ≥50% improvement from baseline in CLASI-A score at each efficacy assessment visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 56
SLEDAI-2K
Change from baseline in SLEDAI-2K score at each efficacy assessment visit among participants with SLE.
Measured: Baseline to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus Erythematosus (CLE)Studies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900867
- Sponsor's protocol ID
- SSGJ-626-CLE-II-01
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of SSGJ-626 in Participants With Active Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07900867
- Acronym / sponsor ID
- SSGJ-626-CLE-II-01
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Keywords
- BDCA2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of subcutaneous (SC) 626 versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
Detailed description
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 (626 200 mg Q4W), study drug B group (626 400 mg Q8W), study drug C group (626 400 mg Q4W), and placebo group, with about 35 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Placebo626 Dose A subcutaneous (SC) injection |
| Group B | Experimental | Drug: Placebo626 Dose B subcutaneous (SC) injection |
| Group C | Experimental | Drug: Placebo626 Dose C subcutaneous (SC) injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed,with or without SLE manifestations.
- CLASI-A total score ≥ 8 points at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
- Currently receiving at least one of the SoC CLE medications.
Key exclusion criteria (5 listed)
- Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
- Active lupus nephritis or moderate-to-severe or chronic kidney disease.
- 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
- History of chronic, recurrent (3 or more of the same type of infection in a 12-month period).
- Has a history of severe herpes infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo subcutaneous (SC) injection | Drug | Group A, Group B, Group C |
Primary outcome
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 24
Time frame: 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
6 secondary outcomes
CLASI-70
Time frame: Baseline to Week 56
CLASI-50
Time frame: Baseline to Week 56
CLASI ≥7
Time frame: Baseline to Week 56
CLA-IGA-R erythema
Time frame: Baseline to Week 56
CLA-IGA-R OMC
Time frame: Baseline to Week 56
SLEDAI-2K
Time frame: Baseline to Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Cutaneous Lupus Erythematosus (CLE), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou (+86 18911301578, zhouginghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.