Trial results for ixekizumab (Taltz) in participants with moderate-to-severe plaque psoriasis or active psoriatic arthritis in India were posted on ClinicalTrials.gov on 2025-08-22. The study demonstrated strong efficacy, with 86.0% of plaque psoriasis patients achieving PASI-75 at Week 12 and 84.0% of active psoriatic arthritis patients achieving ACR20 at Week 24. The trial also investigated the safety and tolerability profile of ixekizumab in this population.
Background
This Phase 4 study aimed to investigate the safety and tolerability of ixekizumab in participants in India diagnosed with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA). Ixekizumab is an established treatment for these conditions, and this study provided further data specifically within the Indian patient population.
Trial design
The study (NCT05855967) was a Phase 4 trial that enrolled 250 participants aged ≥18 years in India. The trial focused on individuals with moderate-to-severe plaque psoriasis or active psoriatic arthritis. The main purpose was to investigate the safety and tolerability of ixekizumab in this specific population. Participants received ixekizumab under different dosing regimens, including Q2W/Q4W and Q4W.
Key results
The trial reported on both safety and efficacy outcomes for ixekizumab in the studied population. For safety, measured from Week 0 to Week 24:
- The number of participants reporting Serious Adverse Events (SAEs) was 1 in the Q2W/Q4W ixekizumab dosing regimen group and 0 in the Q4W ixekizumab dosing regimen group.
- The number of participants reporting Treatment Emergent Adverse Events (TEAEs) was 60 in the Q2W/Q4W ixekizumab dosing regimen group and 8 in the Q4W ixekizumab dosing regimen group.
- The number of participants reporting Adverse Events of Special Interests (AESIs) was 39 in the Q2W/Q4W ixekizumab dosing regimen group and 6 in the Q4W ixekizumab dosing regimen group.
Regarding efficacy outcomes:
- For participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA), the percentage achieving ≥75% improvement from baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 was 86.0%.
- Also for PsO participants with no active PsA, the percentage achieving a Static Physician Global Assessment (sPGA) score of 0 (Clear) or 1 (Minimal) was 65.3%.
- For participants with active psoriatic arthritis (PsA), the percentage who achieved 20% improvement from baseline in American College of Rheumatology 20 (ACR20) at Week 24 was 84.0%.
What this means
The results of this Phase 4 study in India confirm the robust efficacy of ixekizumab in treating both moderate-to-severe plaque psoriasis and active psoriatic arthritis. The high rates of PASI-75 response (86.0%) and ACR20 response (84.0%) align with the drug's established profile in other populations. Furthermore, the low number of reported Serious Adverse Events suggests a favorable safety and tolerability profile for ixekizumab within this specific patient group, supporting its continued use for these indications in India.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05855967, titled "A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India," were posted on 2025-08-22 on clinicaltrials.gov.