Status:
ACTIVE_NOT_RECRUITING
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Lead Sponsor:
Amgen
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 assessm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2027
Estimated Enrollment :
469 Patients enrolled
Trial Details
Trial ID
NCT06527404
Start Date
July 18 2024
End Date
January 19 2027
Last Update
November 17 2025
Active Locations (192)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
First OC Dermatology
Fountain Valley, California, United States, 92708
3
Los Angeles Universal Research Center
Los Angeles, California, United States, 90057
4
Paradigm Clinical Research Center Inc
San Diego, California, United States, 92108