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NCT04736953: STOPSLE
Sirolimus Treatment Of Patients With SLE
Phase 2 trial testing Sirolimus in Lupus Erythematosus, Systemic in 220 participants. Not yet recruiting.
1 January 2029
Quick facts
| Lead sponsor | State University of New York - Upstate Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 1 January 2025 |
| Primary completion | 1 January 2029 |
| Estimated completion | 1 January 2029 |
Drugs / interventions tested
- Sirolimus (sirolimus) — full drug profile →
- Placebo
Conditions studied
- Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →
Sponsor
State University of New York - Upstate Medical University
Who can join
18 and older, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase II Double-blind, placebo-controlled, randomized treatment trial with two arms: one SIROLIMUS arm with 92 patients and one placebo arm with 92 patients. The safety and therapeutic efficacy of SIROLIMUS will be determined within a dosage range of 1 mg/day to 4 mg/day, which will be titrated to tolerance during an initial 3-month open label period, relative to placebo in SLE patients over 12 months followed by a 1-month washout. The proposed study design, known as an enriched enrollment randomized withdrawal (EERW), has major advantages that (1) only people who tolerate SIROLIMUS are randomized, potentially reducing the percentage of dropouts in the randomized phase and (2) it allows participants to use an individualized dosage of study medication, which mimics clinical practice in terms of how SIROLIMUS would be administered. Healthy subjects receive no drugs and serve as controls for in vitro studies.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of lysosomes in physiological activities, diseases, and therapy.
Zhang Z, Yue P, Lu T, Wang Y, et al · · 2021 · cited 238× · PMID 33990205 · DOI 10.1186/s13045-021-01087-1 -
Modulation of the immunity and inflammation by autophagy.
Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311 -
Rapamycin in Cerebral Cavernous Malformations: What Doses to Test in Mice and Humans.
Hagan MJ, Shenkar R, Srinath A, Romanos SG, et al · · 2022 · cited 13× · PMID 35592432 · DOI 10.1021/acsptsci.2c00006
Verify or expand the search:
- PubMed search for NCT04736953
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Lupus Erythematosus, Systemic
Currently open trials in the same condition.
- NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care · recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
- NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
- NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting
Other State University of New York - Upstate Medical University trials
Trials by the same sponsor.
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- NCT06370442 — Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult · Phase 3 · not yet recruiting
- NCT05967455 — Homologous Re-infection With Dengue 1 or Dengue 3 · Phase 1 · completed
- NCT06112093 — Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches · Phase 1 · 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 NCT04736953 (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 State University of New York - Upstate Medical University
- Last refreshed: 5 June 2023
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/NCT04736953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing