A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Purpose

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

  • Prurigo Nodularis

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Blinded Treatment 		Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
  • Drug: Rocatinlimab
    SC Injection
    Other names:
    • AMG 451
Experimental
Arm B: Blinded Treatment 		Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
  • Drug: Rocatinlimab
    SC Injection
    Other names:
    • AMG 451
Experimental
Arm C: Blinded Treatment 		Participants will receive matching placebo SC during Treatment Period A and B.
  • Drug: Placebo
    SC Injection
Experimental
Arm D: Open-label 		Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
  • Drug: Rocatinlimab
    SC Injection
    Other names:
    • AMG 451

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com