Systemic sclerosis & Raynaud's
A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis
Authors' conclusion
This study shows that in patients with dcSSc, safety, pharmacokinetic and bioavailability profiles of IgPro20, and safety and pharmacokinetics of IgPro10, are similar to those observed in other approved indications.
Study context
- Population
- Adults (aged ≥18 years) with dcSSccrossover
- Participants
- 27 adults
- Comparison
- IgPro20 16 weeks followed by IgPro10 16 weeks, or vice versa
- Primary endpoint
- Safety of s.c. immunoglobulin IgPro20
Methodological detailsphase 2, prospective, multicentre, open-label, crossover
- Phase 2
- Prospective
- Multicentre
- Open-label
- Crossover
Primary result
As reported in the abstract
TEAEs
IgPro20
49
events
IgPro10
58
events
- Patients with treatment-emergent adverse events (TEAEs) (107 TEAEs in total); most mild/moderate
- 22 (81.5%)
Secondary outcomes
Maximum IgG concentration
Geometric mean dose-normalized, baseline-corrected AUC from 0 to tau
- Maximum IgG concentration: numerically lower following IgPro20
Bioavailability of IgPro20 relative to IgPro10
- Relative bioavailability
- 76.1%
Safety
Events
| Outcome | IgPro20 | IgPro10 |
|---|---|---|
| SAEsCounts are SAEs, not patients | 6 | 4 |
- Serious adverse events (SAEs) — Patients with SAEs (10 SAEs in total)
- 6 (22.2%)
- SAEs — Treatment-related SAEs
- 0
- SAEs — Deaths
- 0
Infusion site reactions (ISRs) with IgPro20
- ISR rate (low)
- 2 per 100 infusions
Original publication
A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). Published 5 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →