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Evaluating Rocatinlimab for Treating Prurigo Nodularis

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

Phase 3 Interventional Amgen · NCT06527404

This study is testing if a new medication called rocatinlimab can help adults with prurigo nodularis who haven't found relief from other treatments by comparing it to a placebo over 24 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsrocatinlimab
Locations180 sites (Birmingham, Alabama and 179 other locations)
Trial IDNCT06527404 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy of rocatinlimab compared to a placebo in patients with prurigo nodularis over a 24-week period. Participants will report their daily itch scores and overall clinical assessments to evaluate the treatment's effectiveness. The study is designed to include adults who have had prurigo nodularis for at least three months and have not responded adequately to topical therapies. The trial will take place at multiple locations across the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of prurigo nodularis and a history of inadequate response to topical treatments.

Not a fit: Patients with other active skin or systemic conditions that interfere with the assessment of study outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce itching and improve the quality of life for patients suffering from prurigo nodularis.

How similar studies have performed: Other studies have shown promise in treating prurigo nodularis with similar approaches, but the specific efficacy of rocatinlimab is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)
* Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.
* Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1.
* Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.
* History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion Criteria:

* Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).
* Prurigo nodularis secondary to medications.
* Prurigo nodularis secondary to neurologic or psychiatric medical conditions.
* Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.
* Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.

Where this trial is running

Birmingham, Alabama and 179 other locations

+130 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prurigo NodularisRocatinlimab
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.