Trial results for ixekizumab in a Phase 2 study (NCT04979910) for patients with Major Depressive Disorder were posted on ClinicalTrials.gov on 2025-05-20. The study reported a mean change of 28.57 in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores for both response and remission rates.
Background
Ixekizumab is a monoclonal antibody (mAb) against interleukin 17A (IL-17A). This study aimed to test its potential in patients with treatment-resistant depression (TRD), a form of Major Depressive Disorder.
Trial design
The study (NCT04979910) was a Phase 2 trial evaluating ixekizumab in patients with Major Depressive Disorder. It enrolled 7 participants and was completed.
Key results
The trial reported the following key measurements for the ixekizumab group:
- Number of Participants Who Dropped-out: 0 Participants.
- Number of Anticipated and Unanticipated Adverse Events: 8 events.
- For Change in Montgomery-Åsberg Depression Rating Scale Score - Response Rate:
- A mean change of 28.57 (Standard Deviation: 6.55) in score on a scale.
- A mean change of 23.86 (Standard Deviation: 10.07) in score on a scale.
- For Change in Montgomery-Åsberg Depression Rating Scale Score - Remission Rate:
- A mean change of 28.57 (Standard Deviation: 6.55) in score on a scale.
- A mean change of 23.86 (Standard Deviation: 10.07) in score on a scale.
- For Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score:
- A mean change of 13.57 (Standard Deviation: 4.04) in score on a scale.
- A mean change of 11.57 (Standard Deviation: 5.50) in score on a scale.
- For Change in Snaith-Hamilton Pleasure Scale (SHAPS):
- A mean change of 35.29 (Standard Deviation: 11.43) in score on a scale.
- A mean change of 33.14 (Standard Deviation: 12.23) in score on a scale.
- For Change in Temporal Experience of Pleasure Scale:
- A mean change of 57.71 (Standard Deviation: 21.78) in score on a scale.
- A mean change of 63.14 (Standard Deviation: 24.59) in score on a scale.
What this means
The Phase 2 trial of ixekizumab for Major Depressive Disorder, though small with 7 participants, reported changes in several depression and pleasure scales. The observed mean changes in MADRS scores for response and remission, alongside changes in QIDS-SR, SHAPS, and Temporal Experience of Pleasure Scale, suggest potential activity. The trial also noted a favorable safety profile with 0 participant dropouts and 8 adverse events overall. Given the lack of a comparator arm and the limited enrollment, these findings are preliminary and warrant further investigation in larger, controlled studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04979910, titled 'Targeting IL-17A for Treatment-Resistant Depression,' were posted on 2025-05-20 on clinicaltrials.gov.