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NCT07185269
The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE
Phase 1, PHASE2 trial testing 626 in Systemic Lupus Erythematosus (SLE) in 198 participants. Currently enrolling.
12 August 2028
Quick facts
| Lead sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 24 September 2025 |
| Primary completion | 12 August 2028 |
| Estimated completion | 4 November 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- 626
- 626
- Placebo
Conditions studied
- Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Systemic Lupus Erythematosus (SLE). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the effect and safety of 626 in patients with SLE
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07185269
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Systemic Lupus Erythematosus (SLE)
Currently open trials in the same condition.
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- NCT07332481 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease · Phase 3 · recruiting
- NCT06875960 — A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Dis · Phase 4 · recruiting
Other Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. trials
Trials by the same sponsor.
- NCT07507513 — The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC · Phase 2 · not yet recruiting
- NCT07349329 — A Study to Evaluate the Efficacy and Safty of 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA) · Phase 3 · not yet recruiting
- NCT07261644 — A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS) · Phase 3 · recruiting
- NCT07042126 — Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis · Phase 3 · recruiting
- NCT07065136 — Evaluation of 627 in Healthy Adult Subjects · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07185269 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Last refreshed: 26 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07185269.
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