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

Description

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).

Conditions

Prurigo Nodularis

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Prurigo Nodularis
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

First OC Dermatology, Fountain Valley, California, United States, 92708

Los Angeles

Los Angeles Universal Research Center, Los Angeles, California, United States, 90057

San Diego

Paradigm Clinical Research Center Inc, San Diego, California, United States, 92108

Tustin

Wolverine Clinical Trials, Tustin, California, United States, 92780

Hialeah

Direct Helpers Research Center, Hialeah, Florida, United States, 33012

Miami Lakes

Wellness Clinical Research, Miami Lakes, Florida, United States, 33016

Miami

Southern Clinical Research, Miami, Florida, United States, 33125

Miami

University of Miami Hospital, Miami, Florida, United States, 33125

Miami

Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173

Tampa

Clinical Research Trials of Florida Inc, Tampa, Florida, United States, 33607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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).
  • * 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.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-05-15