Rocatinlimab for Prurigo Nodularis

Recruiting at 183 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Biologics, Immunosuppressives

Disqualifiers: Atopic dermatitis, Neurologic, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

460 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic biologic immunosuppressive or immunomodulatory therapy for prurigo nodularis or other autoimmune, inflammatory, or allergic diseases at least 12 weeks before starting the trial. If you are on such medications, you will need to stop them before participating.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for individuals with skin conditions like Atopic Dermatitis and Prurigo Nodularis, who experience severe itching. Participants should be willing to receive injections and not have any health issues that could interfere with the study or pose a risk when taking the trial medication.

Inclusion Criteria

I have been diagnosed with Prurigo Nodularis for at least 3 months.

I have recorded my daily itch levels for the last 7 days.

Topical treatments haven't worked for me or are not safe due to side effects.

Exclusion Criteria

I have itchy bumps on my skin due to a nerve or mental health condition.

I have itchy bumps on my skin caused by medication.

I haven't had skin or systemic conditions in the last 3 months that could affect study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period A

Participants receive either rocatinlimab or placebo subcutaneously

24 weeks

Treatment Period B

Participants continue receiving rocatinlimab or placebo, with an option for open-label rocatinlimab

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Rocatinlimab

Trial Overview The study aims to test Rocatinlimab's effectiveness against a placebo in reducing itchiness at week 24, using patient-reported outcomes and clinical assessments. It's a phase 3 trial where participants won't know if they're getting the real medicine or a dummy injection (double-blind).

Participant Groups

Group I: Arm D: Open-label Experimental Treatment 1 Intervention

Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.

Group II: Arm C: Blinded Treatment Experimental Treatment 1 Intervention

Participants will receive matching placebo SC during Treatment Period A and B.

Group III: Arm B: Blinded Treatment Experimental Treatment 1 Intervention

Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.

Group IV: Arm A: Blinded Treatment Experimental Treatment 1 Intervention

Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London