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Rocatinlimab for Prurigo Nodularis

Recruiting in Palo Alto (17 mi)

+171 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Amgen

Must not be taking: Biologics, Immunosuppressives

Disqualifiers: Atopic dermatitis, Neurologic, Psychiatric, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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 am at least 18 years old or the legal adult age in my country.

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

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

See 2 more

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.

See 2 more

Trial 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 (Monoclonal Antibodies)

Trial OverviewThe 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

4Treatment groups

Experimental Treatment

Group I: Arm D: Open-labelExperimental Treatment1 Intervention

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

Group II: Arm C: Blinded TreatmentExperimental Treatment1 Intervention

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

Group III: Arm B: Blinded TreatmentExperimental Treatment1 Intervention

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

Group IV: Arm A: Blinded TreatmentExperimental Treatment1 Intervention

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