Atopic DermatitisPhase 1NCT06214481
A Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese Participants
A Phase 1 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the pharmacokinetics of rocatinlimab after single subcutaneous (SC) administration in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rocatinlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2024to 5 Jun 2024
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- Healthy male or female participants, between 18 and 65 years of age (inclusive) at the time of screening.
- Body mass index between 18 and 30 kg/m^2 (inclusive) at the time of screening and check-in.
- Provide signed informed consent.
Who cannot join
- History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- Evidence of any active bacterial, viral, or fungal infection at screening including but not limited to upper or lower respiratory tract infection, conjunctivitis, acute otitis media, gastritis, enteritis, skin infections, infections requiring treatment with systemic therapy (antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals) for which therapy has not been completed within 4 weeks before enrollment.
- Immunocompromised participants at risk for viral reactivation including participants with history of solid organ transplantation, hematopoietic stem cell transplantation, or cellular therapy.
- Participants with disrupted skin integrity (apparent burn or dermatitis).
- Prior history of autoimmune disease including but not limited to inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), lupus, rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis.
- Positive hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb) or hepatitis C virus antibody and/or positive human immunodeficiency virus test, at screening. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included.
Show all 14Show fewer
- Positive T-spot test at screening.
- Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines within 120 days after administration of an investigational product.
- Participants who have received coronavirus disease 2019 vaccine within 30 days prior to check-in, or plan to receive a coronavirus disease 2019 vaccine within 120 days post-dose.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- Acetaminophen (paracetamol; up to 2 g/day) for analgesia will be allowed.
- Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.
- Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to check-in.
- Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received the investigational product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rocatinlimab (AMG 451) Administered Subcutaneously in Healthy Chinese Subjects
The primary objective of the study is to evaluate the pharmacokinetics of rocatinlimab after single subcutaneous (SC) administration in healthy Chinese participants.
- Conditions
- Atopic Dermatitis
- Being tested
- Rocatinlimab
- Keywords
- Eczema, AMG 451, KHK4083, Rocatinlimab
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocatinlimabDrug
Also called AMG 451
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Rocatinlimab | Experimental | Participants will receive a single SC dose of rocatinlimab. Receives: Drug: Rocatinlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab
Measured: Up to day 126
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast) of Rocatinlimab
Measured: Up to day 126
AUC from Time Zero to Infinity (AUCinf) of Rocatinlimab
Measured: Up to day 126
Secondary outcomes (3)
Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Up to day 126
Number of Participants Experiencing Serious Adverse Events
Measured: Up to day 126
Number of Participants who Develop Anti-rocatinlimab Antibodies
Measured: Up to day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start23 Jan 2024
- Primary completion27 May 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06214481
- Sponsor's protocol ID
- 20210186
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rocatinlimab (AMG 451) Administered Subcutaneously in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06214481
- Acronym / sponsor ID
- 20210186
- Conditions
- Atopic Dermatitis
- Keywords
- Eczema, AMG 451, KHK4083, Rocatinlimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 19 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 the study is to evaluate the pharmacokinetics of rocatinlimab after single subcutaneous (SC) administration in healthy Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rocatinlimab | Experimental | Drug: RocatinlimabParticipants will receive a single SC dose of rocatinlimab. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- Healthy male or female participants, between 18 and 65 years of age (inclusive) at the time of screening.
- Body mass index between 18 and 30 kg/m^2 (inclusive) at the time of screening and check-in.
- Provide signed informed consent.
Key exclusion criteria (14 listed)
- History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- Evidence of any active bacterial, viral, or fungal infection at screening including but not limited to upper or lower respiratory tract infection, conjunctivitis, acute otitis media, gastritis, enteritis, skin infections, infections requiring treatment with systemic therapy (antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals) for which therapy has not been completed within 4 weeks before enrollment.
- Immunocompromised participants at risk for viral reactivation including participants with history of solid organ transplantation, hematopoietic stem cell transplantation, or cellular therapy.
- Participants with disrupted skin integrity (apparent burn or dermatitis).
- Prior history of autoimmune disease including but not limited to inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), lupus, rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis.
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 451Administered SC. | Drug | Rocatinlimab |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab
Time frame: Up to day 126
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast) of Rocatinlimab
Time frame: Up to day 126
AUC from Time Zero to Infinity (AUCinf) of Rocatinlimab
Time frame: Up to day 126
3 secondary outcomes
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Up to day 126
Number of Participants Experiencing Serious Adverse Events
Time frame: Up to day 126
Number of Participants who Develop Anti-rocatinlimab Antibodies
Time frame: Up to day 126
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 7 Jan 2026.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 1 site in China.
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 4 inclusion and 14 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab (time frame: Up to day 126). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.