Rocatinlimab for Prurigo Nodularis

Not currently recruiting at 238 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, rocatinlimab, for prurigo nodularis, a skin condition that causes itchy bumps. The study compares rocatinlimab to a placebo (a substance with no active treatment) to determine if it can reduce itchiness and improve skin appearance. Participants will receive injections of either rocatinlimab or a placebo. The trial seeks adults who have had prurigo nodularis for at least three months, have tried creams or ointments without success, and have at least 20 nodules on their body. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rocatinlimab has been tested in earlier studies to assess its safety in humans. One study found serious side effects in 4% of people taking rocatinlimab, compared to 2% of those taking a placebo (a harmless pill used for comparison). This indicates that while some individuals might experience serious issues, these are not very common.

Researchers are also studying rocatinlimab for other conditions like asthma and skin problems, carefully monitoring its effects. As this treatment is in a later stage of testing, researchers have already gathered some safety information, indicating it's generally well-tolerated by most people. However, like any treatment, risks may still exist, which is why ongoing studies remain important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prurigo nodularis?

Rocatinlimab is unique because it targets prurigo nodularis in a novel way by modulating the immune system differently than current treatments. While existing options like corticosteroids and antihistamines aim to reduce inflammation and itching, rocatinlimab works by specifically blocking certain pathways involved in the inflammatory response, potentially offering more targeted relief. Moreover, its administration via subcutaneous injection could improve patient compliance and convenience compared to some traditional therapies. Researchers are excited about rocatinlimab because it may provide more effective and rapid relief for those suffering from this chronic and often debilitating skin condition.

What evidence suggests that rocatinlimab might be an effective treatment for prurigo nodularis?

Research has shown that rocatinlimab offers promising results for treating prurigo nodularis and other skin conditions. In studies on atopic dermatitis, a similar condition, rocatinlimab reduced skin severity by up to 61%, significantly lessening symptoms. This trial will administer different doses of rocatinlimab or a placebo to evaluate its effectiveness for prurigo nodularis. Rocatinlimab proved much more effective than a placebo in previous studies, indicating the benefits are real and not by chance. This evidence suggests it could greatly help those with prurigo nodularis by addressing the root causes of their symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06527404

Study Details | NCT06527404 | A Phase 3, Placebo- ...

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 ...

2.

amgen.com

amgen.com/newsroom/press-releases/2025/09/amgen-and-kyowa-kirin-announce-top-line-results-from-rocatinlimab-phase-3-ascend-long-term-extension-study-in-adults-with-moderate-to-severe-atopic-dermatitis

Press Releases

Rocatinlimab is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis and potentially other conditions where T ...

3.

kyowakirin.com

kyowakirin.com/media_center/news_releases/2024/pdf/e20240925_01.pdf

Kyowa Kirin Announces Top-line Data from Rocatinlimab ...

“We are very pleased to have achieved statistically significant efficacy results over placebo which are consistent for co-primary endpoints and ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12126366/

Emerging Therapies in the Treatment of Prurigo Nodularis

Phase 2b trials in AD demonstrated significant efficacy with rocatinlimab, achieving up to 61% reduction in EASI scores and sustained ...

5.

amgentrials.com

amgentrials.com/study/?id=20230053

AMGEN - A Phase 3, Placebo-controlled, Double-blind ...

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 ...

6.

kyowakirin.com

kyowakirin.com/media_center/news_releases/2022/pdf/e20221213_01.pdf

Kyowa Kirin Announces Lancet Publication of Phase 2b ...

The incidence of serious adverse events was 4% in the rocatinlimab group and 2% in the placebo group. “I am pleased that the results of our ...

7.

ctv.veeva.com

ctv.veeva.com/study/a-phase-3-placebo-controlled-double-blind-study-assessing-rocatinlimab-in-prurigo-nodularis

A Phase 3, Placebo-controlled, Double-blind Study Assessing ...

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 ...