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NCT05155345
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus
Completed
Phase 1
Last updated 29 April 2025
What this trial tests
Phase 1 trial testing Mosunetuzumab in Systemic Lupus Erythematosus in 15 participants. Completed in 17 December 2024.
Timeline
11 January 2022
Primary endpoint
17 December 2024
17 December 2024
17 December 2024
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 11 January 2022 |
| Primary completion | 17 December 2024 |
| Estimated completion | 17 December 2024 |
| Sites | 3 locations across Poland, United States, Moldova |
Drugs / interventions tested
- Mosunetuzumab (MOSUNETUZUMAB) — full drug profile →
- Tocilizumab (tocilizumab) — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 75, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0 -
Structure and function of therapeutic antibodies approved by the US FDA in 2023.
Strohl WR. · · 2024 · cited 25× · PMID 38617189 · DOI 10.1093/abt/tbae007 -
Cutting-edge approaches to B-cell depletion in autoimmune diseases.
Robinson WH, Fiorentino D, Chung L, Moreland LW, et al · · 2024 · cited 24× · PMID 39445025 · DOI 10.3389/fimmu.2024.1454747 -
Immune cell aberrations in Systemic Lupus Erythematosus: navigating the targeted therapies toward precision management.
Wu Y, Zhang W, Liao Y, Sun T, et al · · 2025 · cited 11× · PMID 40524185 · DOI 10.1186/s11658-025-00749-z -
Therapeutic potential of CD20/CD3 bispecific antibodies in the treatment of autoimmune diseases.
Huang H, Wei X. · · 2024 · cited 9× · PMID 39802547 · DOI 10.1515/rir-2024-0029 -
Targeted Therapy for SLE-What Works, What Doesn't, What's Next.
Venturelli V, Isenberg DA. · · 2023 · cited 8× · PMID 37176637 · DOI 10.3390/jcm12093198 -
Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7
Verify or expand the search:
- PubMed search for NCT05155345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
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Other Hoffmann-La Roche trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05155345 (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 Hoffmann-La Roche
- Last refreshed: 29 April 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/NCT05155345.
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