A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
NCT Number: NCT06527404
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Prurigo Nodularis
Interventions: DRUG: Rocatinlimab|DRUG: Placebo
Sponsor: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 460
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2027-05-15
Locations: First OC Dermatology, Fountain Valley, California, 92708, United States|Los Angeles Universal Research Center, Los Angeles, California, 90057, United States|Paradigm Clinical Research Center Inc, San Diego, California, 92108, United States|Wolverine Clinical Trials, Tustin, California, 92780, United States|Direct Helpers Research Center, Hialeah, Florida, 33012, United States|Wellness Clinical Research, Miami Lakes, Florida, 33016, United States|Southern Clinical Research, Miami, Florida, 33125, United States|Clinical Research Trials of Florida Inc, Tampa, Florida, 33607, United States|The Indiana Clinical Trials Center PC, Plainfield, Indiana, 46168, United States|Revival Research Institute, LLC, Troy, Michigan, 48084, United States|Optima Research, Boardman, Ohio, 44512, United States|Hightower Clinical, Oklahoma City, Oklahoma, 73102, United States|Center For Clinical Studies PLLC, Houston, Texas, 77004, United States|Clarity Dermatology, Lancaster, Texas, 75146, United States|Springville Dermatology, Springville, Utah, 84663, United States|St George Dermatology and Skin Cancer Centre, Kogarah, New South Wales, 2217, Australia|Adnan Menderes Universitesi Medical Faculty, Aydin, 09100, Turkey|Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun, 55200, Turkey

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).

Primary Outcome Measures: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24, Up to 24 weeks|US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Assessment at Week 24, Up to 24 weeks
Secondary Outcome Measures: Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24, Week 24|Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24, Baseline and Week 24|Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff, Baseline and Week 24|US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24, Baseline and Week 24|Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 16, Baseline and Week 16|Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 16, Week 16|Change from Baseline in Weekly Average of Daily Itch Score at Week 24, Baseline and Week 24|Change from Baseline in Prurigo Nodularis Assessment Score at Week 24, Baseline and Week 24|Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Week 24 in Participants with Baseline Score Greater Than a Cutoff Score, Baseline and Week 24|Change from Baseline in Quality of Life Assessment Score at Week 24, Baseline and Week 24|Change from Baseline in Quality of Life Assessment Score at Week 16, Baseline and week 16|Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 24, Baseline and Week 24|Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24, Baseline and Week 24|Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24 in Participants with Baseline Weekly Average Score Greater Than a Cutoff Score, Baseline and week 24|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., Up to approximately Week 68|Number of Participants Experiencing AEs of Special Interest (EOIs), Up to approximately Week 68|Number of Participants with Anti-rocatinlimab Antibodies, Baseline to Week 68|Serum Concentrations of Rocatinlimab, Baseline to Week 52|Trough Concentration (Ctrough) of Rocatinlimab, Baseline to Week 52