Zilucoplan in immune-mediated necrotising myopathy: a phase 2, randomised, double-blind, placebo-controlled, multicentre trial
Authors' conclusion
C5 inhibition does not appear to be an effective treatment modality for IMNM.
Study context
- Population
- Adults with anti-HMGCR or anti-SRP autoantibody-positive immune-mediated necrotizing myopathy (IMNM)13 female and 14 male
- Participants
- 27 adults
- Comparison
- Daily subcutaneous zilucoplan 0.3mg/kg vs placebo for eight weeks
- Zilucoplann = 12
- Placebon = 15reference
- Primary endpoint
- Percent change from baseline to Week 8 in creatine kinase (CK) levels
- Follow-up
- Week 8
Methodological detailsphase 2, double-blind, placebo-controlled, multicentre, 15 sites (four countries), optional open-label extension
- Phase 2
- Double-blind
- Placebo-controlled
- Multicentre
- 15 sites (four countries)
- Optional open-label extension
Primary result
As reported in the abstract
Percent change in CK vs baseline, mean (SD)
Zilucoplan
−9.86%
mean · SD 26.06
Placebo
−20.72%
mean · SD 31.22
P = 0.46
Safety
Headache (most frequent TEAE) · 8 weeks
Nausea · 8 weeks
| Outcome | Zilucoplan | Placebo |
|---|---|---|
| Serious TEAEs · 8 weeks | — withheld: not confirmed against the abstract | 20.0% |
— withheld: the automatic checks could not confirm the value against the abstract
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Zilucoplan in immune-mediated necrotising myopathy: a phase 2, randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. Published 24 January 2023. doi:10.
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