Efficacy, safety and tolerability of GSK3858279, an anti-CCL17 monoclonal antibody and analgesic, in healthy volunteers and patients with knee osteoarthritis pain: a phase I, randomised, double-blind, placebo-controlled, proof-of-mechanism and proof-of-concept study
Authors' conclusion
GSK3858279 improved pain intensity and WOMAC pain and function scores in adults with knee OA pain and demonstrated favourable safety and tolerability in both healthy participants and adults with knee OA pain.
Study context
- Population
- Part A: healthy participants (randomised 3:1); part B: participants with knee osteoarthritis (OA) pain (randomised 1:1)
- Comparison
- GSK3858279 vs placebo
- Primary endpoint
- Part B: Change from baseline (CFB) in average and worst knee pain intensity (and safety)
- Follow-up
- Week 8
Methodological detailsphase I, double-blind, placebo-controlled, two-part, proof-of-mechanism and proof-of-concept
- Phase I
- Double-blind
- Placebo-controlled
- Two-part
- Proof-of-mechanism and proof-of-concept
Primary result
As reported in the abstract
Median CFB in knee pain intensity, part B
Each group vs placeboEstimate (95% CrI)
GSK3858279
median CFB difference, average pain −1.18(−2.15 to −0.20)
GSK3858279
median CFB difference, worst pain −1.09(−2.29 to 0.12)
Further findings
| Outcome | Estimate | |
|---|---|---|
| WOMAC pain and function scores, median CFB (exploratory) · week 8GSK3858279vs Placebo95% CrI · CrI | median CFB difference, WOMAC pain −1.41 (95% CrI −2.35 to −0.46) | |
| WOMAC pain and function scores, median CFB (exploratory) · week 8GSK3858279vs Placebo95% CrI · CrI | median CFB difference, WOMAC function −1.29 (95% CrI −2.28 to −0.29) | |
| −3−2−101Difference (linear scale) |
Serious adverse events (AEs) or deaths
- None observed
Safety
AEs among participants receiving GSK3858279
- Part A (most common: nasopharyngitis)
- 72% (26/36)
- Part B (most common: injection site reactions)
- 88% (21/24)
Original publication
Efficacy, safety and tolerability of GSK3858279, an anti-CCL17 monoclonal antibody and analgesic, in healthy volunteers and patients with knee osteoarthritis pain: a phase I, randomised, double-blind, placebo-controlled, proof-of-mechanism and proof-of-concept study. Ann Rheum Dis. Published 28 March 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →