Trial results for a Phase 4 study (NCT03440736) investigating secukinumab 300 mg combined with a lifestyle intervention for moderate to severe psoriasis patients with concomitant metabolic syndrome were posted on ClinicalTrials.gov on 2026-04-22. The combination therapy demonstrated statistically significant improvements in Psoriasis Area and Severity Index (PASI) 75, hsCRP, and HbA1c compared to secukinumab alone.
Background
The study aimed to assess if secukinumab 300 mg combined with a lifestyle intervention could improve skin symptoms and cardiometabolic status more than secukinumab alone in patients with moderate to severe psoriasis and concomitant metabolic syndrome. This approach targeted the shared pathophysiology of systemic inflammation underlying both conditions.
Trial design
The study (NCT03440736) was a Phase 4, randomized, open-label, parallel-group, active comparator controlled study that enrolled 781 participants. It investigated the treatment of moderate to severe psoriasis patients with concomitant metabolic syndrome. Participants were assigned to one of two arms: secukinumab 300 mg subcutaneous (s.c.) alone or secukinumab 300 mg subcutaneous (s.c.) combined with a lifestyle intervention.
Key results
Key results from the trial demonstrated the following for the comparison of secukinumab 300 mg alone (Arm A) versus secukinumab 300 mg combined with lifestyle intervention (Arm B):
- For the "Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28": 219 Participants in Arm A and 261 Participants in Arm B achieved this outcome. A logistic regression analysis comparing mean change between treatments in PASI 90 at week 28 yielded an Odds Ratio (OR) of 1.17 (95.0% CI: 0.82 to 1.67) with a p-value of 0.3857.
- For the "Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Week 28": 239 Participants in Arm A and 265 Participants in Arm B achieved this outcome. A logistic regression analysis for PASI 75 at Week 28 showed an Odds Ratio (OR) of 1.8 (95.0% CI: 1.06 to 3.06) with a p-value of 0.03, favoring the combination arm.
- A logistic regression analysis for PASI 100 at Week 28 showed an Odds Ratio (OR) of 0.87 (95.0% CI: 0.61 to 1.24) with a p-value of 0.4351.
- The mean change from Baseline in absolute PASI Score at week 28, analyzed by Mixed Models Analysis, showed a Mean Difference (Net) of -0.2 (95.0% CI: -1.0 to 0.5) with a p-value of 0.5443.
- For the comparison of mean change between treatments in hsCRP at week 28, Mixed Models Analysis indicated a value of -0.114 (95.0% CI: -0.194 to -0.033) with a p-value of 0.0057, favoring the combination arm.
- For HbA1c, the comparison of mean change between treatments at week 28, analyzed by Mixed Models Analysis, showed a least squares (LS) mean change of -0.09 (95.0% CI: -0.14 to -0.04) with a p-value of 0.0012, favoring the combination arm.
What this means
The trial results suggest that adding a lifestyle intervention to secukinumab 300 mg therapy may provide additional benefits for patients with moderate to severe psoriasis and concomitant metabolic syndrome. While the improvement in PASI 90 and absolute PASI score was not statistically significant, the combination therapy significantly improved PASI 75 response, as well as key cardiometabolic markers such as hsCRP and HbA1c. These findings highlight the potential for a holistic approach to manage both skin symptoms and metabolic comorbidities in this patient population, aligning with the study's aim to target shared systemic inflammation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03440736, titled "Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome," were posted on 2026-04-22 on clinicaltrials.gov.