Trial results for the Phase 2 study (NCT04633447) investigating guselkumab for participants with new-onset or relapsing Giant Cell Arteritis were posted on ClinicalTrials.gov on 2025-07-01. The study showed that 40.0% of participants receiving guselkumab achieved glucocorticoid (GC)-free remission at Week 28, compared to 33.3% for those on placebo.
Background
The study, titled "A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis," aimed to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing Giant Cell Arteritis (GCA).
Trial design
The study (NCT04633447) was a Phase 2, randomized, placebo-controlled trial that enrolled 53 participants. The study investigated guselkumab in participants diagnosed with new-onset or relapsing Giant Cell Arteritis. Participants were randomly assigned to receive either guselkumab or a placebo, in combination with a 26-week glucocorticoid taper regimen.
Key results
The trial results evaluated the percentage of participants achieving glucocorticoid (GC)-free remission. For the outcome of "Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28":
- Participants receiving guselkumab achieved 40.0% GC-free remission.
- Participants receiving placebo achieved 33.3% GC-free remission.
For the outcome of "Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52", the results for guselkumab and placebo, respectively, were:
- Week 28: 40.0% vs 33.3%
- Week 32: 34.3% vs 33.3%
- Week 36: 34.3% vs 33.3%
- Week 40: 34.3% vs 33.3%
- Week 44: 34.3% vs 33.3%
- Week 48: 34.3% vs 33.3%
- Week 52: 34.3% vs 33.3%
A Cochran-Mantel-Haenszel analysis showed a difference in percentage of 6.6 (90.0% CI: -14.7 to 27.9) between the groups, with a p-value of 0.638.
What this means
The results from this Phase 2 trial indicate that guselkumab did not demonstrate a statistically significant difference in achieving glucocorticoid-free remission compared to placebo in participants with new-onset or relapsing Giant Cell Arteritis. The observed difference of 6.6% in remission rates at Week 28 was not statistically significant, as indicated by the p-value of 0.638. The study was terminated, suggesting that further development for this indication based on these results may not proceed.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04633447, titled "A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis," were posted on 2025-07-01 on clinicaltrials.gov.