Atopic DermatitisPhase 3ROCKET-OrbitNCT05633355
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 77 sites in 9 countries.
Trial summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rocatinlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 77 sitesin 9 countries
- Study dates
- 30 Jan 2023to 31 Jul 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 12 to < 18 years at day 1.
- Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent
- Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
- Eczema Area and Severity Index (EASI) score ≥ 12
- vIGA-AD score ≥ 3
- ≥ 10% BSA of AD involvement at day 1 pre-enrollment
Who cannot join
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- Systemic corticosteroids
- Systemic immunosuppressants
- Phototherapy
- Oral or topical janus kinase inhibitors
Show all 10Show fewer
- Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
- Topical PDE4 inhibitors
- Other topical immunosuppressive agents (not including TCS/TCI)
- Combination topical agents containing a high- or super-high potency corticosteroid
Trial locations and contacts
77 sites in 9 countries.
77 sites in 9 countries
United States22 sites
Dermatology Trial Associates
Bryant, Arkansas, 72022
Driscoll Childrens Hospital
Corpus Christi, Texas, 78411
Modern Research Associates
Dallas, Texas, 75231
Windsor Dermatology dba Eczema Treatment Center of New Jersey
East Windsor, New Jersey, 08520
Auni Allergy
Findlay, Ohio, 45840
Center for Clinical Studies
Houston, Texas, 77004
University of California Irvine
Irvine, California, 92697
Smart Medical Research Inc
Jackson Heights, New York, 11372
Manlio Dermatology
Kissimmee, Florida, 34741
Bluegrass Allergy Care
Lexington, Kentucky, 40509
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, 72205
University of California Los Angeles
Los Angeles, California, 90024
Dermatology Research Associates
Los Angeles, California, 90045
Palm Springs Community Health Center
Miami, Florida, 33014
ARA Professionals Limited Liability Corporation
Miami, Florida, 33176
Deluxe Health Care LLC
Miami Lakes, Florida, 33014
University of Utah MidValley Dermatology
Murray, Utah, 84107
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Phoenix Childrens Hosptial
Phoenix, Arizona, 85016
Oregon Medical Research Center
Portland, Oregon, 97201
DermDox Dermatology, LLC
Sugarloaf, Pennsylvania, 18249
Medical Advancement Centers of Arizona
Tempe, Arizona, 85283
Canada13 sites
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6
Dermatology Research Institute Incorporated
Calgary, Alberta, T2J 7E1
Stratica Dermatology
Edmonton, Alberta, T5K 1X3
Vida Clinical Research
Edmonton, Alberta, T6H 4J8
LEADER Research
Hamilton, Ontario, L8L 3C3
Triple A Lab
Hamilton, Ontario, L8S 1G5
JRB Research Incorporated
Ottawa, Ontario, K2C 3N2
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Skincare Studio
St. John's, Newfoundland and Labrador, A1E 1V4
Toronto Research Centre Inc
Toronto, Ontario, M3H 5Y8
FACET Dermatology
Toronto, Ontario, M4E 1R7
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
Australia9 sites
The Skin Centre
Benowa, Queensland, 4217
Monash Childrens Hospital
Clayton, Victoria, 3168
The Skin Hospital
Darlinghurst, New South Wales, 2010
Premier Specialists
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 2170
Institute for Skin Health and Immunity
Mitcham, Victoria, 3132
Woden Dermatology
Phillip, Australian Capital Territory, 2606
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Veracity Clinical Research
Woolloongabba, Queensland, 4102
South Korea9 sites
Korea University Ansan Hospital
Ansansi, Gyeonggido, 15355
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
National Medical Center
Seoul, 04564
Kyung Hee University Hospital at Gangdong
Seoul, 05278
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ewha Womans University Seoul Hospital
Seoul, 07804
Argentina6 sites
Fundacion Cidea
Buenos Aires, Distrito Federal, 1121
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, 1425
Cinme - Centro de Investigaciones Metabolicas
CABA, Buenos Aires, C1027AAP
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
Rosario, Santa Fe Province, 2000
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Instituto de Diagnostico ABC
Rosario, Santa Fe Province, 2000
Brazil6 sites
Universidade Federal do Parana
Curitiba, Paraná, 80060-240
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, 09060-870
Ispem-Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, 12243-280
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
São Paulo, 06454-010
United Kingdom6 sites
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
Velocity Clinical Research, High Wycombe
High Wycombe, HP11 2QW
Alder Hey Childrens Hospital
Liverpool, L12 2AP
Whipps Cross University Hospital
London, E11 1NR
St Thomas Hospital
London, SE1 7EH
Carn to Coast Health Centres
Redruth, TR16 4ET
Turkey (Türkiye)5 sites
Bezmialem Vakif Universitesi Hastanesi
Istanbul, 34093
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, 35620
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, 38030
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200
About this study
Official title: A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
- Conditions
- Atopic Dermatitis
- Being tested
- Rocatinlimab
- Keywords
- Atopic Dermatitis, Rocatinlimab, AMG 451, KHK4083
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocatinlimabDrug
Also called AMG 451
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Rocatinlimab | Experimental | Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2. Receives: Drug: Rocatinlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment.
A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention.
Measured: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start30 Jan 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633355
- Sponsor's protocol ID
- 20210263
- Other IDs
- 2022-001548-99
- Acronym
- ROCKET-Orbit
- Status last verified
- Jun 2026
- First submitted
- 22 Nov 2022
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
PubMed 40012373
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
- ClinicalTrials.gov ID
- NCT05633355
- Acronym / sponsor ID
- ROCKET-Orbit / 20210263
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Rocatinlimab, AMG 451, KHK4083
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rocatinlimab | Experimental | Drug: RocatinlimabRocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ≥ 12 to < 18 years at day 1.
- Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent
- Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
- Eczema Area and Severity Index (EASI) score ≥ 12
- vIGA-AD score ≥ 3
Key exclusion criteria (10 listed)
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocatinlimabAlso: AMG 451Subcutaneous (SC) injection | Drug | Rocatinlimab |
Primary outcome
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40012373Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
77 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 77 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Canada, Australia, South Korea, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs) (time frame: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.