Recruiting

Nemolizumab

Sponsor:

Galderma R&D

Code:

NCT06988618

Conditions

Prurigo Nodularis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The main aim of this study is to assess real-world effectiveness of nemolizumab in Prurigo nodularis (PN) as measured by investigator and patient reported outcome (PRO) in clinical practice at Month 6.

Conditions

Prurigo Nodularis

Study ID

NCT06988618

Start date

Aug 11, 2025

Status verified date

Aug, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants who, according to the treating physician's decision and in line with the local package label, are newly initiated on nemolizumab (Nemluvio®) for the treatment of PN.
  • Participants greater than or equal to (>=) 18 years of age.
  • Participants who signed the written informed consent form (ICF).

Exclusion Criteria:

  • Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label;
  • Participants who received treatment with a drug under clinical development/ investigation within 3 months prior to baseline.
  • Participants who received nemolizumab previously.
  • Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Nemolizumab

Participants with moderate-to-severe PN who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.

Primary outcome measure

  • Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6 [ Time Frame: At 6 month ]
  • Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6 [ Time Frame: At 6 month ]

Central Contacts and Locations

Central contacts

Galderma Research and Development

817-961-5000clinical.studies@galderma.com

Locations

Galderma Investigational Site # 6836

Recruiting

Fountain Valley, California, United States, 92708-3701

Galderma Investigational Site # 7055

Recruiting

Portsmouth, New Hampshire, United States, 03801-7156

More Information

Sponsor

Galderma R&D

Last update posted

Jun 1, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Galderma R&D on 2026-06-01.