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Phase 3 Study Assessing Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
EU CTIS ID: 2022-501535-16-00
What this study is testing
To describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD
- 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
- Subject’s legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- vIGA-AD score ≥ 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) at day 1 pre-enrollment.
- ≥ 10% BSA of AD involvement at initial screening.
- ≥ 10% BSA of AD involvement at day 1 pre-enrollment.
- Subjects who are receiving psychiatric treatment regimen need to be stable on treatment for at least 2 months prior to study day 1 pre-enrollment.
- Age ≥ 12 to < 18 years at day 1.
You likely can't join if
- Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
- Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within 4 weeks before day 1 pre-enrollment.
- Superficial skin infections within 2 weeks before day 1 pre-enrollment.
- Severe depression, poorly controlled schizophrenia, or subjects who have had an inpatient psychiatric admission within the last year.
- History of suicide attempt or suicidal ideation as evidenced by XXX
- Recent suicide attempt or suicidal ideation or behavior as XXX
See the full eligibility criteria
Who can join
- Subject’s legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- vIGA-AD score ≥ 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) at day 1 pre-enrollment.
- ≥ 10% BSA of AD involvement at initial screening.
- ≥ 10% BSA of AD involvement at day 1 pre-enrollment.
- Subjects who are receiving psychiatric treatment regimen need to be stable on treatment for at least 2 months prior to study day 1 pre-enrollment.
- Age ≥ 12 to < 18 years at day 1.
- Subject has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 6 months before signing of informed consent.
- Body weight ≥ 40 kg at screening.
- Body weight ≥ 40 kg at day 1 pre-enrollment.
- Prior to informed consent, history of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI as appropriate). • Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to vIGA-AD score of 0 = clear to 2 = mild) despite treatment with a daily regimen of TCS of medium or higher potency with or without TCI as appropriate), applied for at least 28 days or the maximum duration recommended by the product prescribing information (eg, 14 days for super-high potent TCS), whichever is shorter.
- EASI score ≥ 16 at initial screening.
- EASI score ≥ 16 at day 1 pre-enrollment.
- vIGA-AD score ≥ 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) at initial screening.
What rules you out
- Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
- Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within 4 weeks before day 1 pre-enrollment.
- Superficial skin infections within 2 weeks before day 1 pre-enrollment.
- Severe depression, poorly controlled schizophrenia, or subjects who have had an inpatient psychiatric admission within the last year.
- History of suicide attempt or suicidal ideation as evidenced by XXX
- Recent suicide attempt or suicidal ideation or behavior as XXX
- Any of the following laboratory abnormalities at initial screening: • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times the upper limit of normal (ULN) • Neutrophil count < 1.5 x 10^3/µL
- Treatment with a biologic immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic condition XXX within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-enrollment.
- Any cell depletion therapy within 12 months from initial screening or until cell count returns to normal before screening, whichever is longer.
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-enrollment: • Systemic corticosteroids (inhaled corticosteroids, intra-articular steroid injection, eye, ear, or nasal drops containing corticosteroids are allowed, suppositories, thalidomide, or enemas containing corticosteroids are not allowed) • Systemic treatment with methotrexate, mycophenolate, calcineurin inhibitors, thalidomide, or other systemic immunosuppressants • Phototherapy • Oral or topical JAK inhibitors • TCS with high- or super high-potency
- Treatment with any of the following agents within 1 week before day 1 pre-enrollment: • TCS • TCI • Anti-pruritic agents (e.g., crotamiton) or antihistamines used for treatment of pruritus • Topical phosphodiesterase type 4 (PDE4) inhibitors • Other topical immunosuppressive agents • Combination topical agents containing a corticosteroid or calcineurin-inhibiting component
- History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab.
- Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1. Inactive vaccination (eg, non-live or nonreplicating agent), including COVID-19 vaccination, is allowed.
- Previous participation in a study including rocatinlimab (formerly KHK4083 or AMG 451) or any therapy selectively targeting OX40/OX40L and receipt of active investigational product.
- Currently receiving treatment in another investigational device or drug study, or less than 30 days (16 weeks for Japan) since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 16 weeks after the last dose of investigational product.
- Female subjects who are breastfeeding or who plan to breastfeed while on study through 16 weeks after the last dose of investigational product.
- Female subjects planning to become pregnant while on study through 16 weeks after the last dose of investigational product.
- Female subjects of childbearing potential with a positive pregnancy test assessed at initial screening and day 1 pre-enrollment by a highly sensitive serum or urine pregnancy test, respectively.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
- History or evidence of any other clinically significant disorder (including concomitant dermatologic conditions such as psoriasis), or disease, including non-AD dermatologic conditions (with the exception of those outlined above) 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.
- Known sensitivity to any of the products or components to be administered during dosing.
- Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-enrollment that had not been treated with or had failed to respond to standard of care therapy.
- Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at initial screening or current acquired, common variable or inhibited, primary or secondary immunodeficiency.
- Positive for hepatitis C virus (HCV) antibody at initial screening with confirmed positive HCV RNA.
- Active and non-virally suppressed hepatitis B infection at initial screening, defined as detectable hepatitis B DNA polymerase chain reaction (PCR) test in a subject with detectable hepatitis B Surface Antigen (HBsAg) and/or antibodies to hepatitis B core (anti-HBc). Subjects with detectable HBsAg are required to be virally suppressed with an approved hepatitis B antiviral therapy during the study.
- Positive or indeterminate XXX from central laboratory at initial screening. Exception: A positive or indeterminate XXX test is allowed if ALL of the following are present at initial screening: • No symptoms of tuberculosis (TB) as XXX • Documented history of a completed course of adequate prophylaxis (completed treatment for latent TB per local standard of care prior to start of investigational product) • No known exposure to a case of active TB after most recent prophylaxis • No evidence of active TB on XXX
- A corrected QT interval (QTc) of > 450 msec in males or > 470 msec in females at initial screening as assessed by the investigator, or history of long QT syndrome.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Brazil
- United States
- Korea, Republic of
- Canada
- Argentina
- Turkey
- United Kingdom
- Australia
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Brazil; United States; Korea, Republic of; Canada; Argentina and 3 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.