Lupus & antiphospholipid syndrome
A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis
Authors' conclusion
These data support further development of PF-06835375 to assess the clinical potential for B and Tfh cell depletion as a treatment for autoimmune diseases.
Study context
- Population
- Patients aged 18–70 years with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA)treated
- Participants
- 73 patients
- Comparison
- PF-06835375 IV single doses or SC repeat doses vs placebo
- Primary endpoint
- Safety, tolerability, pharmacokinetics and pharmacodynamics (TEAEs, PK parameters, effects on B and cTfh cells)
Methodological detailsPhase 1, first-in-human, multicentre, double-blind, placebo-controlled, single and multiple ascending dose
- Phase 1
- First-in-human
- Multicentre
- Double-blind
- Placebo-controlled
- Single and multiple ascending dose
Primary result
As reported in the abstract
Pharmacokinetics and pharmacodynamics
Mean t1/2, single ascending dose (SAD) cohorts
3.4-121.4 h
Mean t1/2, multiple ascending dose (MAD) cohorts (Day 29)
162.0-234.0 h
Range of mean maximum depletion B/cTfh cells, SAD (dose-dependent reductions)
67.3-99.3%/62.4-98.7%
Range of mean maximum depletion B/cTfh cells, MAD
91.1-99.6%/89.5-98.1%
Safety
Events
| Outcome | Placebo | PF-06835375 |
|---|---|---|
| TEAEsMost were mild or moderate | 17 | 45 |
- Treatment-emergent adverse events (TEAEs) — Patients with TEAEs, overall
- 62 (84.9%)
Serious adverse events
- Patients with serious adverse events
- 3 (9.7%)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis. Arthritis Res Ther. Published 6 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →