Nemolizumab for Chronic Itch

(CPUO Trial)

Recruiting at 13 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Galderma R&D

Must not be taking: Antibiotics, Antivirals, Antifungals, Antiparasitics

Disqualifiers: Dermatologic, Neurologic, Psychiatric, Infections, others

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

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how nemolizumab, an experimental drug, might alleviate chronic itch without a specific cause. Participants will receive either nemolizumab or a placebo (a substance with no active drug) over 16 weeks to assess the drug's effects on their bodies and its impact on the itch. Individuals with an unexplained and persistent itch for at least six months, affecting several body parts, and who haven't found relief with other treatments, might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain prohibited medications before the baseline visit, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that nemolizumab is likely to be safe for humans?

Research has shown that nemolizumab is generally safe for use. In one study, patients took nemolizumab for 16 weeks and experienced significant relief from itching and skin problems. The treatment was well-tolerated, with no major safety issues reported.

Another study examined the effects of using nemolizumab for 68 weeks. It found that the medication continued to alleviate itching and improved overall quality of life, with no new safety concerns identified.

Overall, these studies suggest that nemolizumab is safe for treating chronic itch, with few serious side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nemolizumab is unique because it targets the IL-31 receptor, a fresh approach for tackling chronic itch. Unlike standard treatments like antihistamines and corticosteroids, which often address symptoms broadly, nemolizumab specifically inhibits the signaling pathway involved in itch sensation. This precision could mean more effective relief for patients who haven't found success with traditional options. Researchers are excited because this could revolutionize how we manage chronic itch, potentially offering quicker and more targeted relief.

What evidence suggests that nemolizumab might be an effective treatment for chronic itch?

Research has shown that nemolizumab, which participants in this trial may receive, may help reduce chronic itching. One study found it significantly lessened the signs and symptoms of prurigo nodularis, a condition causing severe itch. Another report noted that nemolizumab provided ongoing and lasting relief from itch and improved quality of life over 68 weeks. Additionally, a series of cases involving patients with chronic itch unresponsive to other treatments reported positive results with nemolizumab. These findings suggest that nemolizumab could effectively manage chronic itch conditions. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with chronic itch on normal skin for at least 6 months, affecting multiple body areas, and not controlled by previous treatments can join. They must have a specific itch severity score and agree to use contraception. Exclusions include prior nemolizumab study participation, certain infections or conditions, recent substance abuse, pregnancy, or weight under 30 kg.

Inclusion Criteria

I am a woman who cannot become pregnant.

Signed informed consent

Peak Pruritus Numeric Rating Scale (PP NRS) score >= 7 in the 24-hour period prior to the Screening visit

Exclusion Criteria

Previous participation in a clinical study with nemolizumab

I needed treatment for severe itching during the screening.

Hypersensitivity to the active substance or excipients of the study intervention

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 16 weeks to assess PK/PD relationship

16 weeks

4 visits (in-person) at Weeks 0, 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person) at Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Nemolizumab

Trial Overview

The trial is testing the effects of Nemolizumab compared to a placebo in adults with chronic pruritus (itch) of unknown cause over a period of 16 weeks. It aims to understand how the drug works in the body and its impact on itching.

How Is the Trial Designed?

Group I: nemolizumab Experimental Treatment 1 Intervention

Participants weighing \< 90 kg will receive one subcutaneous (SC) injection of 30 milligrams (mg) nemolizumab (with 60 mg loading dose at baseline) every 4 weeks (Q4W) at Weeks 4, 8, and 12. Participants weighing \>= 90 kg will receive two SC injections of 30 mg nemolizumab ( 60 mg total) at baseline (without loading dose) and at Weeks 4, 8, and 12.

Group II: Placebo Placebo Group 1 Intervention

Participants weighing \< 90 kg will receive two SC injections of matching placebo at baseline followed by 1 SC injection Q4W at Weeks 4, 8 and 12. Participants weighing \>= 90 kg will receive two SC injections of matching placebo at baseline and at Weeks 4, 8, and 12.

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

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40112876/

Long-term (68 weeks) administration of nemolizumab and ...

Nemolizumab elicited continuous and durable improvements across multiple measures of pruritus, PN severity and QoL over 68 weeks of treatment, with no new ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2301333

Phase 3 Trial of Nemolizumab in Patients with Prurigo ...

Nemolizumab monotherapy significantly reduced the signs and symptoms of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT04501679; EudraCT ...

3.

jcadonline.com

jcadonline.com/nemolizumab-chronic-pruritus/

Nemolizumab Demonstrates Marked Efficacy in ...

Results. Our case series included 12 patients (Table 1) with treatment-resistant chronic pruritus who were successfully treated with nemolizumab (Table 2).

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03181503

NCT03181503 | Safety and Efficacy of Nemolizumab in PN

This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study to evaluate the safety and efficacy of nemolizumab over a 12-week ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0365059625001527

Efficacy and safety of nemolizumab in prurigo nodularis

Our meta-analysis shows that Nemolizumab significantly improves pruritus, IGA success rates, and PAS > 75% in treating patients with moderate to severe PN. Its ...

6.

jamanetwork.com

jamanetwork.com/journals/jamadermatology/article-abstract/2827129

Efficacy and Safety of Nemolizumab in Patients With ...

Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase ...

7.

galderma.com

galderma.com/news/rad-2025-nemluvio

RAD 2025: Long-term data on Nemluvio® (nemolizumab) ...

The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating ...