A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
NCT06224192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151
Last updated 2026-03-25
Summary
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
Conditions
Interventions
- COMBINATION_PRODUCT
-
Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
- COMBINATION_PRODUCT
-
Rocatinlimab AI
AI for SC injection self-administration of rocatinlimab.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-02
- Primary Completion
- 2025-04-11
- Completion
- 2026-03-16
- FDA Drug
- Yes
Countries
- United States
- Canada
- Japan
- South Korea
Study Locations
More Related Trials
-
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05882877 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
NCT05651711 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
NCT06224348 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)
NCT06181435 ·Status: COMPLETED ·Phase: PHASE3
-
A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis
NCT03920852 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
NCT03011892 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
NCT06407934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
NCT06130566 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Ruxolitinib Cream in Children With Atopic Dermatitis
NCT05034822 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
NCT06241118 ·Status: RECRUITING ·Phase: PHASE3
-
Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis
NCT06026891 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
NCT06012812 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
NCT06832618 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
NCT06238817 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
NCT05456529 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
NCT05970432 ·Status: UNKNOWN ·Phase: PHASE2
-
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
NCT05492578 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2/PHASE3
-
A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis
NCT07103174 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
NCT02087943 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
NCT06863961 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT05769777 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients
NCT06765005 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
NCT03415282 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis
NCT07211542 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
NCT04040192 ·Status: COMPLETED ·Phase: PHASE3