Trial results for nemolizumab in participants with chronic kidney disease (CKD) associated moderate to severe pruritus were posted on ClinicalTrials.gov on 2025-02-20. The study showed that 26.6% of participants on nemolizumab 60 mg achieved a >=4-point improvement in Worst Itch Numeric Rating Scale (WI NRS) from baseline at Week 4, compared to 7.4% for placebo, with a p-value of 0.0025.
Background
Chronic kidney disease (CKD) associated pruritus is a common and distressing symptom for patients, particularly those undergoing hemodialysis. Moderate to severe pruritus can significantly impact quality of life, sleep, and overall well-being.
Trial design
This completed Phase 2/3 trial (NCT05075408) enrolled 258 participants to evaluate the efficacy and safety of nemolizumab in adults with Chronic Kidney Disease Associated Moderate to Severe Pruritus who were undergoing hemodialysis. The study compared nemolizumab 30 mg and nemolizumab 60 mg against placebo over a 12-week treatment period, aiming to reduce the intensity of pruritus.
Key results
The trial assessed the percentage of responders achieving a significant improvement in itch intensity and sleep disturbance. Key findings for nemolizumab 60 mg compared to placebo include:
- At Week 4, for an improvement of Worst Itch Numeric Rating Scale (WI NRS) >= 4 from baseline:
- Nemolizumab 60 mg: 26.6% of participants.
- Placebo: 7.4% of participants.
- The strata adjusted percentage difference for nemolizumab 60 mg versus Placebo was 17.1% (97.5% CI: 4.5, 29.8), with a p-value of 0.0025.
- At Week 12, for an improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 from baseline:
- Nemolizumab 60 mg: 42.6% of participants.
- Placebo: 25.3% of participants.
- The strata adjusted percentage difference for nemolizumab 60 mg versus Placebo was 17.3% (97.5% CI: 4.3, 30.4), with a p-value of 0.0034.
- At Week 12, for an improvement of WI NRS >= 4 from baseline:
- Nemolizumab 60 mg: 47.7% of participants.
- Nemolizumab 30 mg: 38.5% of participants.
- Placebo: 32.4% of participants.
- The strata adjusted percentage difference for nemolizumab 60 mg versus Placebo was 14.5% (97.5% CI: -3.1, 32.2), with a p-value of 0.0686.
What this means
The results indicate that nemolizumab, particularly at the 60 mg dose, demonstrated an early and statistically significant improvement in pruritus intensity as measured by the Worst Itch Numeric Rating Scale at Week 4, compared to placebo. Furthermore, the 60 mg dose also showed a statistically significant improvement in sleep disturbance at Week 12. While the 12-week primary pruritus response rate for the 60 mg dose showed a numerical advantage over placebo, it did not reach statistical significance at the predefined threshold in the hierarchical testing procedure. These findings suggest a potential benefit of nemolizumab for managing moderate to severe pruritus and associated sleep issues in patients with chronic kidney disease.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05075408, titled "To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus," were posted on 2025-02-20 on clinicaltrials.gov.