20230053 Enrolling

Clinical Trial for Prurigo Nodularis (68 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults aged 18 and above diagnosed with prurigo nodularis (PN) may participate.

Inclusion Criteria

  • Diagnosis of prurigo nodularis for at least 3 months
  • Have ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk
  • Have a history of inadequate response to TCS of medium or higher potency for prurigo nodularis

What Are The Benefits?

  • No cost to participate or receive study treatment
  • Regular visits with study doctors who specialize in treating PN (18 visits)
  • Will receive either an investigative subcutaneous injection or a placebo

How Long Will The Study Last?

Around 68 weeks


Participating Locations

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: October 04, 2024

Official Title

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

ClinicalTrials.gov ID

NCT06527404

Sponsor

Amgen

Study Description

  • Brief Summary:

    The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

  • Condition or Disease:

    Prurigo Nodularis

  • Intervention/Treatment:

    Drug: Rocatinlimab Drug: Rocatinlimab Drug: Placebo Drug: Rocatinlimab
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    18 Years and 100 Years (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL

Inclusion Criteria

  • Diagnosis of prurigo nodularis for at least 3 months
  • Have ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk
  • Have a history of inadequate response to TCS of medium or higher potency for prurigo nodularis

Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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