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

Phase 3Active Not RecruitingNCT06527404

Amgen469 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

469

Conditions

Prurigo Nodularis

Interventions

RocatinlimabDRUG

SC Injection

PlaceboDRUG

SC Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (192)

Outcomes

Primary Outcomes

Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

Time frame: Up to 24 weeks

US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24

Time frame: Up to 24 weeks

Secondary Outcomes

Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24

Time frame: Week 24

Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24

Time frame: Baseline and Week 24

Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24

Time frame: Baseline and Week 24

Global: Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff

Time frame: Baseline and Week 24

US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

Time frame: Baseline and Week 24

US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24

Time frame: Week 24

US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

First OC Dermatology

Fountain Valley, California, United States

Los Angeles Universal Research Center

Los Angeles, California, United States

Paradigm Clinical Research Center Inc

San Diego, California, United States

Wolverine Clinical Trials

Santa Ana, California, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Southern Clinical Research

Miami, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Miami Dermatology and Laser Institute

Miami, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

...and 182 more locations

US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment at Week 24 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score

Time frame: Week 24

Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52

Time frame: Baseline, Week 24, Week 36 and Week 52

Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52

Time frame: Baseline, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52

Time frame: Baseline, Week 16, Week 36 and Week 52

Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52

Time frame: Week 36 and Week 52

Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52

Time frame: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52

Time frame: Week 36 and Week 52

Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52

Time frame: Week 24, Week 36 and Week 52

Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52

Time frame: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Score Greater Than or Equal to a Cutoff Score

Time frame: Baseline, Week 24, Week 36 and Week 52

Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52

Time frame: Baseline, Week 24, Week 36 and Week 52

Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52

Time frame: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Weekly Average Score Greater Than or Equal to a Cutoff Score

Time frame: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52

Time frame: Baseline, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 36 and 52 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score

Time frame: Baseline, Week 36 and Week 52

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical study subject irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious TEAE is any untoward medical occurrence that meets one of the following criteria: Is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or another medically important serious event.

Time frame: Up to approximately Week 68

Number of Participants Experiencing AEs of Special Interest (EOIs)

Time frame: Up to approximately Week 68

Number of Participants with Anti-rocatinlimab Antibodies

Time frame: Baseline to Week 68

Serum Concentrations of Rocatinlimab

Time frame: Baseline to Week 52

Trough Concentration (Ctrough) of Rocatinlimab

Time frame: Baseline to Week 52