A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
- Registration Number
- NCT06527404
- Lead Sponsor
- Amgen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Blinded Treatment Rocatinlimab Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B. Arm C: Blinded Treatment Placebo Participants will receive matching placebo SC during Treatment Period A and B. Arm B: Blinded Treatment Rocatinlimab Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B. Arm D: Open-label Rocatinlimab Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
- Primary Outcome Measures
Name Time Method 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 Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24 Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24 Week 24 Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24 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 Baseline and Week 24 US Only: Number of Participants with Improvement in Prurigo Nodularis Assessment at Week 24 Week 24 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately Week 68 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.
Number of Participants Experiencing AEs of Special Interest (EOIs) Up to approximately Week 68 Serum Concentrations of Rocatinlimab Baseline to Week 52 Trough Concentration (Ctrough) of Rocatinlimab Baseline to Week 52 Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch 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 Change from Baseline in Quality of Life Assessment Score at Week 16 Baseline and week 16 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 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 Number of Participants with Anti-rocatinlimab Antibodies Baseline to Week 68
Trial Locations
- Locations (180)
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
🇺🇸Tustin, California, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Wellness Clinical Research
🇺🇸Miami Lakes, 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
Scroll for more (170 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States