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A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
EU CTIS ID: 2024-510753-10-00
What this study is testing
To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints on the PRO measure of pruritus
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- A clinical diagnosis of prurigo nodularis (as defined by core symptoms according to the United States expert panel consensus [Elmariah et al, 2021]), that has been present for at least 3 months before signing of informed consent. The prurigo nodularis defined core symptoms include pruritus for more than 6 weeks, evidence of chronic scratching, and presence of multiple pruriginous lesions and excoriated nodules.
- Patient-reported average itching score based on electronic daily diary assessment the last 7 days prior to day 1, at day 1 prerandomization.
- Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk at initial screening and at day 1 prerandomization.
- Prior to informed consent, history of inadequate response topical therapies for prurigo nodularis or for whom topical therapies is otherwise medically inadvisable (eg, because of important side effects or safety risks). - Inadequate response is defined as inability to achieve and/or maintain a low disease state despite treatment with a daily regimen of topical therapies, - Participants with any previous systemic treatment or phototherapy for prurigo nodularis or topical Janus kinase (JAK) inhibitors for prurigo nodularis, independent of response, are also considered as inadequate responders and are potentially eligible to be included in the study after appropriate washout.
You likely can't join if
- Skin or systemic morbidities, other than prurigo nodularis, that have been active or requiring treatment within the last 3 months, prior to screening that interfere with the assessment of study outcomes
- Any of the following laboratory abnormalities at initial screening: - eGFR < 30 mL/min/1.73 m2 - AST or ALT: ≥ 2.5 times the upper limit of normal (ULN) - neutrophil count: < 1.5 x 103/µL
- Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within the specified time period before day 1 prerandomization.
- History of New York Heart Association class III/IV heart failure; diagnosis of uncontrolled hypertension at initial screening; or inadequately treated cardiovascular conditions at initial screening including: cardiomyopathy, major congenital heart disease, or second or third-degree atrioventricular block.
- Recent cardiovascular events including cerebrovascular accident, myocardial infarction, coronary stenting, or unstable angina within 6 months of day 1 prerandomization
See the full eligibility criteria
Who can join
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- A clinical diagnosis of prurigo nodularis (as defined by core symptoms according to the United States expert panel consensus [Elmariah et al, 2021]), that has been present for at least 3 months before signing of informed consent. The prurigo nodularis defined core symptoms include pruritus for more than 6 weeks, evidence of chronic scratching, and presence of multiple pruriginous lesions and excoriated nodules.
- Patient-reported average itching score based on electronic daily diary assessment the last 7 days prior to day 1, at day 1 prerandomization.
- Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk at initial screening and at day 1 prerandomization.
- Prior to informed consent, history of inadequate response topical therapies for prurigo nodularis or for whom topical therapies is otherwise medically inadvisable (eg, because of important side effects or safety risks). - Inadequate response is defined as inability to achieve and/or maintain a low disease state despite treatment with a daily regimen of topical therapies, - Participants with any previous systemic treatment or phototherapy for prurigo nodularis or topical Janus kinase (JAK) inhibitors for prurigo nodularis, independent of response, are also considered as inadequate responders and are potentially eligible to be included in the study after appropriate washout.
- Participants must have completed at least 4 days of daily diary entries within the 7 days preceding and including day 1 prerandomization.
What rules you out
- Skin or systemic morbidities, other than prurigo nodularis, that have been active or requiring treatment within the last 3 months, prior to screening that interfere with the assessment of study outcomes
- Any of the following laboratory abnormalities at initial screening: - eGFR < 30 mL/min/1.73 m2 - AST or ALT: ≥ 2.5 times the upper limit of normal (ULN) - neutrophil count: < 1.5 x 103/µL
- Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within the specified time period before day 1 prerandomization.
- History of New York Heart Association class III/IV heart failure; diagnosis of uncontrolled hypertension at initial screening; or inadequately treated cardiovascular conditions at initial screening including: cardiomyopathy, major congenital heart disease, or second or third-degree atrioventricular block.
- Recent cardiovascular events including cerebrovascular accident, myocardial infarction, coronary stenting, or unstable angina within 6 months of day 1 prerandomization
- Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
- Positive for HCV antibody at initial screening with confirmed positive HCV RNA.
- Chronic hepatitis B infection at initial screening, defined as detectable HBsAg or HBV DNA.Participants with detectable anti-HBc and negative HBsAg/HBV DNA are required to do on-study HBV DNA monitoring.
- Active or latent tuberculosis infection as evident by positive or indeterminate QuantiFERON GOLD from central laboratory at initial screening and assessed at day 1 prerandomization per Screening TB Risk Assessment Questionnaire provided by Amgen.
- A corrected QT interval (QTc ) of > 450 msec in males of > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome.
- History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted,would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
- Prurigo nodularis secondary to medications.
- Prurigo nodularis secondary to neurologic or psychiatric medical conditions
- Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
- Superficial skin infection within 2 weeks before day 1 prerandomization.
- Known sensitivity to any of the products or components to be administered during dosing.
- Major psychiatric illness,within 1 year before day 1 prerandomization.
- Inpatient psychiatric admission within 1 year before day 1 prerandomization.
- Change in psychiatric medication for a psychiatric illness within 8 weeks before day 1 prerandomization.
- Anticipated need to change psychiatric medication for a psychiatric illness during the study.
- History of alcohol or substance abuse within 6 months prior to initial screening.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Australia
- Brazil
- China
- Taiwan
- Chile
- United Kingdom
- Mexico
- Switzerland
- Turkey
- United States
- Canada
- Korea, Republic of
- Japan
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Australia; Brazil; China; Taiwan; Chile and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.