Nemolizumab for Itching in Chronic Kidney Disease

(NIKAIA 1 Trial)

Recruiting at 64 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

258 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing nemolizumab, a medication aimed at reducing itching. It focuses on adults undergoing hemodialysis who suffer from moderate to severe itching. The drug works by blocking a protein that triggers the itch sensation. Nemolizumab is a medication developed for treating various skin diseases, including itching associated with chronic kidney disease.

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.

What data supports the effectiveness of the drug Nemolizumab for itching in chronic kidney disease?

Nemolizumab has been shown to effectively reduce itching in conditions like atopic dermatitis by blocking a protein called interleukin-31 (IL-31), which is involved in causing itchiness. This suggests it might also help with itching in chronic kidney disease, as similar mechanisms could be involved. ^{1 2 3 4 5}

Is Nemolizumab safe for humans?

Nemolizumab has been tested in clinical trials for conditions like atopic dermatitis and has shown mild and temporary side effects such as worsening of skin conditions, skin infections, and upper respiratory infections. Serious side effects were rare, making it generally safe for human use. ^{1 2 3 5 6}

How is the drug Nemolizumab unique for treating itching in chronic kidney disease?

Nemolizumab is unique because it targets the interleukin-31 (IL-31) receptor, which is involved in causing itchiness, and is administered as an injection under the skin. This makes it different from other treatments that may not specifically target this pathway or use different administration methods. ^{1 2 3 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

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

2. Japan pubmed.ncbi.nlm.nih.gov

Anti-pruritic effect of nemolizumab in hemodialysis patients with uremic pruritus: a phase II, randomized, double-blind, placebo-controlled clinical study. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Nemolizumab: First Approval. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus. [2020]

6. Spain pubmed.ncbi.nlm.nih.gov

Nemolizumab for atopic dermatitis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Dosage Optimization of Nemolizumab Using Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Modeling and Simulation. [2019]