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Monoclonal Antibodies
Rocatinlimab for Prurigo Nodularis
Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)
Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately week 68
Awards & highlights
Pivotal Trial
Summary
"This trial will assess if roctatinlimab is better than a placebo in reducing itching and improving overall clinical assessment after 24 weeks, as reported by the patients."
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects of Rocatinlimab are not listed here, common ones may include reactions at the injection site, headaches, fatigue, or flu-like symptoms. Placebo injections usually have no active ingredients but can cause similar minor reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or the legal adult age in my country.
Select...
I have 20 or more itchy bumps on both sides of my legs, arms, or trunk.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have itchy bumps on my skin due to a nerve or mental health condition.
Select...
I haven't taken any immune system affecting drugs for my condition in the last 12 weeks or 5 half-lives, whichever is longer.
Select...
I have itchy bumps on my skin caused by medication.
Select...
I have not received any live vaccines in the last 12 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately week 68
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately week 68
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rocatinlimab
2023
Completed Phase 3
~1720
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,457 Previous Clinical Trials
1,400,196 Total Patients Enrolled
MDStudy DirectorAmgen
994 Previous Clinical Trials
943,940 Total Patients Enrolled