ClinicalTrials.gov recorded primary completion on 26 May 2023 for a completed Phase 3 extension study of secukinumab in people with moderate to severe hidradenitis suppurativa. The study enrolled 702 participants and assessed continued versus interrupted treatment across two secukinumab dose regimens. Among HiSCR responders, median time to loss of response through week 104 ranged from 171 to 365 days across the reported groups.
Background
The trial evaluated long-term treatment with secukinumab in hidradenitis suppurativa, a condition listed in the registry as the study’s indication. It was an extension study for participants completing two Phase 3 core studies. The registry described the objectives as assessing maintenance of Hidradenitis Suppurativa Clinical Response, or HiSCR, during continuous or interrupted therapy, as well as long-term efficacy, safety, and tolerability.
Trial design
This was a Phase 3, completed extension study with 702 participants. The study included two secukinumab dose regimens and a randomized withdrawal period to compare non-interrupted treatment with treatment interruption. The reported outcome was time to loss of response through week 104 among participants who had achieved HiSCR. The supplied data do not list a primary outcome measurement or provide an adverse-event summary.
Key results
For the Q2W regimen, the median time to loss of response was 283 days with continued Q2W treatment and 239 days in the Q2W-to-placebo group. For the Q4W regimen, the corresponding medians were 365 days with continued Q4W treatment and 171 days in the Q4W-to-placebo group. The registry labels the dispersion measure as a 95% confidence interval, but no interval values were supplied.
Reported loss-of-response incidence values included 26.9% for Q2W-to-Q2W, 23.9% for Q2W-to-placebo, 24.2% for Q4W-to-Q4W, and 30.2% for Q4W-to-placebo. The record also contains entries of 0.0% for each of these four groups under the same outcome label, without further explanation in the supplied data.
Two log-rank analyses reported hazard ratios of 0.87, with a 95% confidence interval of 0.59 to 1.29 and p=0.25, and 0.70, with a 95% confidence interval of 0.47 to 1.05 and p=0.044. The supplied record does not identify which treatment comparisons correspond to these analyses.
What this means
The results describe how long HiSCR responders remained in response during continued or interrupted secukinumab treatment. Median response duration was longest in the Q4W-to-Q4W group and shortest in the Q4W-to-placebo group, while the reported incidence values varied across groups. Because the supplied data do not specify the analysis comparisons or provide an adverse-event summary, they do not establish a broader safety conclusion or regulatory action.
Source
Source: ClinicalTrials.gov, completed trial-results record for NCT04179175, dated 26 May 2023. The registry record is available at clinicaltrials.gov/study/NCT04179175.