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

Primary Outcome Measures

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

Secondary Outcome Measures

1. Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24
2. Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24
3. Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
4. 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
5. US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
6. US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24
7. US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
8. 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
9. Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52
10. Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52
11. Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52
12. Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52
13. Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52
14. Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52
15. Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52
16. Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52
17. 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
18. Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52
19. Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52
20. 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
21. Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52
22. 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
23. 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.
24. Number of Participants Experiencing AEs of Special Interest (EOIs)
25. Number of Participants with Anti-rocatinlimab Antibodies
26. Serum Concentrations of Rocatinlimab
27. Trough Concentration (Ctrough) of Rocatinlimab