Nemolizumab for Itching in Chronic Kidney Disease

(NIKAIA 1 Trial)

No longer recruiting at 69 trial locations

Overseen By Galderma Research & Development

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Galderma R&D

Disqualifiers: Asthma, Stroke, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests nemolizumab, a medication designed to reduce severe itching in individuals undergoing regular hemodialysis for chronic kidney disease-related itching. Participants will receive either nemolizumab or a placebo to assess the drug's effectiveness over 12 weeks. Individuals who have undergone hemodialysis three times a week for at least three months and experience persistent itching due to kidney disease may qualify for this study. As a combined Phase 2 and Phase 3 trial, this study evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants must adhere to restrictions on certain medications before and during the study, so it's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nemolizumab is generally safe for patients. Studies have found no major side effects. For example, a study on people with chronic kidney disease showed that nemolizumab was safe and did not lead to serious problems. While some minor side effects might occur, no major safety issues have been reported. These findings are based on research from past studies with similar patient groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for itching in chronic kidney disease focus on general symptom relief, often with antihistamines or corticosteroids. But Nemolizumab stands out because it targets the IL-31 receptor, a key player in the itch-signaling pathway, potentially offering more precise relief. Researchers are excited about Nemolizumab because it could address the root cause of itching rather than just masking symptoms. This targeted approach may lead to more effective and long-lasting relief for patients struggling with this uncomfortable condition.

What evidence suggests that nemolizumab might be an effective treatment for itching in chronic kidney disease?

Research has shown that nemolizumab may help reduce itching in people with chronic kidney disease. In this trial, participants will receive either nemolizumab at 30 mg or 60 mg, or a placebo. One study found that nemolizumab worked well for patients with severe itching who did not get relief from other treatments. Real-world evidence indicates that nemolizumab can quickly ease itching in difficult cases of uremic pruritus, a common issue for people on dialysis. Patients reported significant relief from itching, making it a promising option for those dealing with this condition. Overall, nemolizumab appears to be a safe and effective treatment for reducing itching in patients on dialysis. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Adults on hemodialysis for chronic kidney disease with moderate to severe itching (pruritus) lasting over three months can join. They must have a stable dialysis routine, no recent infections or hospitalizations for asthma, and not be pregnant or breastfeeding. Women able to have children must agree to use contraception or practice abstinence.

Inclusion Criteria

Understands and signs an informed consent form (ICF) before any investigational procedure(s) are performed.

I have severe kidney disease and have been on dialysis 3 times a week for 3 months.

I have had itching for 3 months or more, with no cause found other than kidney disease.

Exclusion Criteria

You don't follow the instructions for hemodialysis, according to the doctor.

You have had issues with drinking alcohol or using drugs in the last six months.

Currently participating or participated in any other study of an investigational drug or device, within the past four weeks (or five half-lives of the investigational medication, whichever is longer) before the screening visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nemolizumab or placebo for 12 weeks to evaluate the efficacy in reducing pruritus intensity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nemolizumab
• Placebo

Trial Overview The trial is testing Nemolizumab against a placebo in reducing itchiness over 12 weeks in adults undergoing hemodialysis. Participants will randomly receive either the study drug or a placebo without knowing which one they are getting.

How Is the Trial Designed?

Group I: Nemolizumab 60 mg Experimental Treatment 1 Intervention

Group II: Nemolizumab 30 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Nemolizumab is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Nemluvio for:

• Prurigo nodularis
• Atopic dermatitis

Approved in European Union as Nemluvio for:

• Atopic dermatitis
• Prurigo nodularis

Approved in Japan as Nemluvio for:

• Atopic dermatitis

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

Nemolizumab is a novel biologic approved for treating itching associated with atopic dermatitis, showing significant efficacy in reducing pruritus and improving skin symptoms and quality of life over a 16-week period in patients aged 13 and older.

While effective, nemolizumab can cause worsening of atopic dermatitis and other side effects, necessitating careful monitoring and management of patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological profiles and clinical findings of nemolizumab as treatment for pruritus associated with atopic dermatitis]. Kaneda, N.[2023]

Nemolizumab, an anti-IL-31 receptor monoclonal antibody, has shown significant efficacy in reducing itching (pruritus) and to a lesser extent, skin inflammation (dermatitis) in patients with atopic dermatitis, based on multiple phase II and III studies.

The treatment has a rapid onset of action and a mild side effect profile, with severe adverse effects being rare, making it a promising option for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab for atopic dermatitis. Labib, A., Vander Does, A., Yosipovitch, G.[2022]

In a 52-week extension study involving 191 patients, nemolizumab maintained significant improvements in pruritus and dermatitis scores, particularly in the 0.5 mg/kg Q4W group, demonstrating its long-term efficacy for treating moderate-to-severe atopic dermatitis.

The treatment was overall well tolerated, with 83% to 89% of patients experiencing at least one adverse event, but no new safety concerns were identified, indicating a favorable safety profile over the 64-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. Kabashima, K., Furue, M., Hanifin, JM., et al.[2019]

In a 16-week phase 3 trial involving 215 Japanese patients with moderate-to-severe atopic dermatitis, nemolizumab significantly reduced pruritus (itchiness) compared to placebo, with a mean percent change in the visual-analogue scale (VAS) score of -42.8% versus -21.4%.

Nemolizumab also showed greater improvements in overall skin severity (EASI score) and quality of life (DLQI score) compared to placebo, although it had a higher incidence of injection-related reactions (8% vs 3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus. Kabashima, K., Matsumura, T., Komazaki, H., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127145/

Effectiveness of Nemolizumab in Improving Dialysis ... We report a case of a patient with persistent dialysis-related pruritus despite initial treatment with difelikefalin.

2. cureus.com cureus.com/articles/403163-real-world-evidence-demonstrating-nemolizumabs-rapid-efficacy-in-recalcitrant-uremic-pruritus

Real-World Evidence Demonstrating Nemolizumab's ... This case highlights the potential of nemolizumab as an effective and safe treatment option for recalcitrant uremic pruritus. Further ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12510728/

Real-World Evidence Demonstrating Nemolizumab's Rapid ... This case highlights the potential of nemolizumab as an effective and safe treatment option for recalcitrant uremic pruritus. Further ...

4. jcadonline.com jcadonline.com/nemolizumab-chronic-pruritus/

Nemolizumab Demonstrates Marked Efficacy in ... This retrospective review evaluates the efficacy and safety of nemolizumab in a series of patients with treatment-resistant chronic pruritus.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04501666

NCT04501666 | Study to Assess the Efficacy and Safety of ... The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age ...

6. ema.europa.eu ema.europa.eu/en/documents/rmp/nemluvio-epar-risk-management-plan_en.pdf

NEMLUVIO (nemolizumab) – Risk Management Plan (RMP) Nemolizumab is also being investigated by the Applicant in the indication of chronic kidney disease ... safety data from both LTE studies for long-term safety ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761391s000lbl.pdf

FULL PRESCRIBING INFORMATION - accessdata.fda.gov It is unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety or effectiveness of these vaccines. No data are available on ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8260520/

Anti-pruritic effect of nemolizumab in hemodialysis patients ... In this phase II study in patients with UP, the primary efficacy parameter was not met. Nemolizumab was generally well tolerated with no clinically significant ...

9. dermnetnz.org dermnetnz.org/topics/nemolizumab

Nemolizumab: Uses, Benefits and Side-effects It was found to be clinically effective and tolerable. Use in uraemic pruritus secondary to chronic kidney disease. Patients with chronic kidney disease may ...