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NCT06238531
A Clinical Trial to Evaluate Safety of Gusacitinib in Patients With Systemic Lupus Erythematosus (SLE) or Lupus
Phase 1 trial testing Gusacitinib in Systemic Lupus Erythematosus. Withdrawn.
22 January 2025
Quick facts
| Lead sponsor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 22 January 2025 |
| Primary completion | 22 January 2025 |
| Estimated completion | 23 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gusacitinib — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Who can join
Adults 18 to 99, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Systemic lupus erythematosus (SLE), also called lupus, is a disease that causes the body s immune system to attack healthy tissue. Lupus causes swelling and inflammation in the skin, skin, joints, kidneys, brain, blood vessels, and other organs. There is no cure for lupus. Current treatments do not help everyone and may have adverse effects. Better treatments are needed. Objective: To test a study drug (Gusacitinib) in people with lupus. Eligibility: People aged 18 years and older with lupus. Design: Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. They will have a chest X-ray. They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body. Participants will have 9 clinic visits and 6 phone visits over about 7 months. The study has 3 parts. Part 1: Gusacitinib is a tablet taken by mouth. Participants will be divided into 3 groups. One group will receive the study drug, and a second group will get a placebo. The placebo looks like the study drug but does not contain any medicine. Both of these groups will take their tablets once a day for 12 weeks. The third group will continue to take their usual medications for lupus throughout the study. Part 2: All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks. Part 3: All participants who took the study drug will stop taking it for 4 weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Therapeutically targeting proinflammatory type I interferons in systemic lupus erythematosus: efficacy and insufficiency with a specific focus on lupus nephritis.
Lai B, Luo SF, Lai JH. · · 2024 · cited 4× · PMID 39478861 · DOI 10.3389/fimmu.2024.1489205
Verify or expand the search:
- PubMed search for NCT06238531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) trials
Trials by the same sponsor.
- NCT07012057 — Study of Deucravacitinib for Refractory Adults With Dermatomyositis/Juvenile Dermatomyositis · Phase 2 · withdrawn
- NCT05440422 — The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN- · Phase 2 · recruiting
- NCT05738824 — Natural History of Inflammatory Muscle Diseases · recruiting
- NCT05567198 — Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Det · recruiting
- NCT05502796 — Natural History and Pathogenesis of Alopecia in Children and Adults · completed
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 NCT06238531 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Last refreshed: 13 March 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/NCT06238531.
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