Atopic DermatitisPhase 3ROCKET-OutpostNCT06224192
A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
A Phase 3 study testing Rocatinlimab Prefilled Syringe and Rocatinlimab AI in people with Atopic Dermatitis, run by Amgen at 47 sites in 4 countries.
Trial summary
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rocatinlimab Prefilled Syringe and Rocatinlimab AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 47 sitesin 4 countries
- Study dates
- 2 Apr 2024to 16 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 at Day 1.
- Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
- History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
- Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
- ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.
Who cannot join
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
- Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
- Systemic corticosteroids
- Non-biologic, non-targeted systemic immunosuppressants
- Oral or Topical Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
Show all 9Show fewer
- Topical phosphodiesterase 4 (PDE4) inhibitors
- Other topical immunosuppressive agents (not including TCS/TCI)
- Combination topical agents containing any of the above components
Trial locations and contacts
47 sites in 4 countries.
47 sites in 4 countries
United States22 sites
Hamilton Research, LLC
Alpharetta, Georgia, 30022
Kern Research Inc
Bakersfield, California, 93301
Bexley Dermatology Research
Bexley, Ohio, 43209
Treasure Valley Medical Research
Boise, Idaho, 83706
Cumberland Skin Center
Hermitage, Tennessee, 37076
Direct Helpers Research Center
Hialeah, Florida, 33012
Excel Clinical Research
Las Vegas, Nevada, 89109
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, 66211
Long Beach Research Institute
Long Beach, California, 90805
Dermatology Research Associates
Los Angeles, California, 90045
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
Sms Clinical Research Limited Liability Company
Mesquite, Texas, 75149
Anchor Medical Research
Miami, Florida, 33176
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
Havana Research Institute Inc
Pasadena, California, 91105
Texas Dermatology Research Center
Plano, Texas, 75025
Health Concepts
Rapid City, South Dakota, 57702
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Integrative Skin Science and Research
Sacramento, California, 95815
Essential Medical Research LLC
Tulsa, Oklahoma, 74137
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, 27103
Canada11 sites
LEADER Research
Hamilton, Ontario, L8L 3C3
Interior Dermatology Centre
Kelowna, British Columbia, V1W 4V5
Lynderm Research Inc
Markham, Ontario, L3P 1X3
DermEdge Research Incorporated
Mississauga, Ontario, L4Y 4C5
Allergy Research Canada Incorporated
Niagara Falls, Ontario, L2H 1H5
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
FACET Dermatology
Toronto, Ontario, M4E 1R7
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research, Incorporated
Windsor, Ontario, N8T 1E6
Japan7 sites
Ekihigashi Dermatology Allergy Clinic
Fukuoka, Fukuoka, 812-0013
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Matsuo Clinic
Fukuoka, Fukuoka, 819-0373
Suizenji Dermatology Clinic
Kumamoto, Kumamoto, 862-0950
Mita Dermatology Clinic
Minato-ku, Tokyo, 108-0014
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, 593-8324
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
South Korea7 sites
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Severance Hospital Yonsei University Health System
Seoul, 03722
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Asan Medical Center
Seoul, 05505
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
- Conditions
- Atopic Dermatitis
- Being tested
- Rocatinlimab Prefilled Syringe, Rocatinlimab AI
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocatinlimab Prefilled SyringeCombination product
Also called AMG 451
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
Rocatinlimab AICombination product
Also called AMG 451
AI for SC injection self-administration of rocatinlimab.
| Study group | Role | What they receive |
|---|---|---|
| Rocatinlimab Dose 1 Prefilled Syringe (PFS) | Experimental | Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. Receives: Combination Product: Rocatinlimab Prefilled Syringe |
| Rocatinlimab Dose 2 PFS | Experimental | Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. Receives: Combination Product: Rocatinlimab Prefilled Syringe |
| Rocatinlimab Dose 2 Autoinjector (AI) | Experimental | Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks. Receives: Combination Product: Rocatinlimab AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16
Measured: Up to Week 16
Secondary outcomes (1)
Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start2 Apr 2024
- Primary completion11 Apr 2025
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 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
- NCT06224192
- Sponsor's protocol ID
- 20230180
- Acronym
- ROCKET-Outpost
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)
- ClinicalTrials.gov ID
- NCT06224192
- Acronym / sponsor ID
- ROCKET-Outpost / 20230180
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
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 assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rocatinlimab Dose 1 Prefilled Syringe (PFS) | Experimental | Combination Product: Rocatinlimab Prefilled SyringeRocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. |
| Rocatinlimab Dose 2 PFS | Experimental | Combination Product: Rocatinlimab Prefilled SyringeRocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. |
| Rocatinlimab Dose 2 Autoinjector (AI) | Experimental | Combination Product: Rocatinlimab AIRocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 12 at Day 1.
- Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
- History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
- Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
Key exclusion criteria (9 listed)
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
- Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
- Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
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 |
|---|---|---|
| Rocatinlimab Prefilled SyringeAlso: AMG 451Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab. | Combination product | Rocatinlimab Dose 1 Prefilled Syringe (PFS), Rocatinlimab Dose 2 PFS |
| Rocatinlimab AIAlso: AMG 451AI for SC injection self-administration of rocatinlimab. | Combination product | Rocatinlimab Dose 2 Autoinjector (AI) |
Primary outcome
Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16
Time frame: Up to Week 16
1 secondary outcome
Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16
Time frame: Up to Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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
47 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rocatinlimab Prefilled Syringe and Rocatinlimab AI in people with Atopic Dermatitis, run by Amgen at 47 sites in 4 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 9 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada, Japan, South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16 (time frame: Up to Week 16). 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 NCT06224192, 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 25 Mar 2026.