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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Prurigo Nodularis

In brief

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).

Key facts

Study ID

NCT06527404

Run by

Amgen

People needed

469

Starts

2024-07-18

Expected to finish

2026-06-25

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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
• Clinical Research Trials of Florida Inc — Tampa, Florida, United States
• Olympian Clinical Research - Tampa — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Endeavor Health Clinical Trials Center — Skokie, Illinois, United States
• The Indiana Clinical Trials Center PC — Plainfield, Indiana, United States
• Revival Research Institute, LLC — Troy, Michigan, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Optima Research — Boardman, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Wright State Physicians — Fairborn, Ohio, United States
• Hightower Clinical — Oklahoma City, Oklahoma, United States
• Center For Clinical Studies PLLC — Houston, Texas, United States
• Clarity Dermatology — Lancaster, Texas, United States
• Springville Dermatology — Springville, Utah, United States
• Hospital Universitario Austral — Derqui, Pilar, Buenos Aires, Argentina
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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