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

Conditions

• Chronic Pruritus of Unknown Origin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• nemolizumab — DRUG
  Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
• Placebo — DRUG
  Participants will receive matching placebo as SC injection.

Study Details

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.

Key Dates

Start date

Oct 20, 2025

Status verified

Nov 2025

Primary completion

Sep 30, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: nemolizumab
  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.
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

Population Pharmacokinetics (PopPK) Model of the Elimination of nemolizumab During the 16-week Treatment Period Point [ Time Frame: From Baseline up to Week 16 ]

Central Contacts

• Galderma Research and Development
  817-961-5000
  [email protected]

Locations (25)

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