Phase 3 Study Assessing Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
- Conditions
- Atopic Dermatitis (AD)MedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-501535-16-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 172
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.
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 produ
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method