NCT07074977

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)

An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.

Detailed description

This study is to assess the PK/PD relationship of nemolizumab in adult participants with CPUO. The study will consist of a 2 to 4-week screening period, a 16-week treatment period, and an 8-week follow up period (12 weeks after last study drug injection). Participants will be randomized 4:1 to nemolizumab or placebo. Dosing will be adjusted according to participants body weight ( less than \[\<\] 90 kilograms \[kg\] versus \>= 90 kg). Participation in the study will last up to 28 weeks.

Conditions

• Chronic Pruritus of Unknown Origin

Interventions

Type	Name	Description
DRUG	nemolizumab	Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
DRUG	Placebo	Participants will receive matching placebo as SC injection.

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2025-07-20
• Last updated: 2026-02-23

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study