Atopic DermatitisPhase 1NCT06438263
A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
A Phase 1 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 3 sites in United States.
Trial summary
The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- 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
- 231 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Aug 2024to 2 Jul 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Healthy male or female participants, between 18 and 60 years of age (inclusive)
- Body mass index between 18 and 32 kg/m2 (inclusive)
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.
- History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
- A QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec in male participants or > 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in.
- Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted.
- Estimated glomerular filtration rate less than 70 mL/min/1.73 m2
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- Alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal at Screening or Check-in.
- Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen [HBsAg] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included.
- Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 90 days after administration of an investigational product.
- Inactive vaccination (e.g., non-live or nonreplicating agent), including coronavirus-2019 (COVID-19) vaccination, is allowed.
- History of latent tuberculosis or active chronic, recurrent, or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before Screening.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in, excluding the following:
- Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed.
- Hormonal contraception listed in Appendix 3 will be allowed.
- Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.
- All herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee) and in consultation with the Sponsor.
- 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 rocatinlimab.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
About this study
Official title: An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects
The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.
- Conditions
- Atopic Dermatitis
- Being tested
- Rocatinlimab
- Keywords
- Rocatinlimab, AMG 451, Dermatology, Pharmacokinetics, Safety
- 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
Vial supplied as a single-use preservative free solution for SC injection.
RocatinlimabDrug
Also called AMG 451
Autoinjector for SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection. Receives: Drug: Rocatinlimab |
| Treatment B | Experimental | Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection. Receives: Drug: Rocatinlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Rocatinlimab
Measured: Up to approximately 112 days
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Measured: Up to approximately 112 days
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Measured: Up to approximately 112 days
Secondary outcomes (2)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs.
A serious AE (SAE) is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Approximately 20 weeks
Number of Participants with Anti-rocatinlimab Antibodies
Measured: Up to approximately Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start6 Aug 2024
- Primary completion3 May 2025
- Study completion2 Jul 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 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
- NCT06438263
- Sponsor's protocol ID
- 20220014
- Status last verified
- Jan 2026
- First submitted
- 27 May 2024
- Last updated
- 20 Jan 2026
- Results posted
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06438263
- Acronym / sponsor ID
- 20220014
- Conditions
- Atopic Dermatitis
- Keywords
- Rocatinlimab, AMG 451, Dermatology, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 3 May 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 31 May 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 main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: RocatinlimabParticipants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection. |
| Treatment B | Experimental | Drug: RocatinlimabParticipants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Healthy male or female participants, between 18 and 60 years of age (inclusive)
- Body mass index between 18 and 32 kg/m2 (inclusive)
Key exclusion criteria (18 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.
- History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
- A QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec in male participants or > 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in.
- Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted.
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 451Vial supplied as a single-use preservative free solution for SC injection. | Drug | Treatment A |
| RocatinlimabAlso: AMG 451Autoinjector for SC injection. | Drug | Treatment B |
Primary outcome
Maximum Plasma Concentration (Cmax) of Rocatinlimab
Time frame: Up to approximately 112 days
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Time frame: Up to approximately 112 days
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Time frame: Up to approximately 112 days
2 secondary outcomes
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 20 weeks
Number of Participants with Anti-rocatinlimab Antibodies
Time frame: Up to approximately Day 112
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 20 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.
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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
3 sites 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 3 sites in United States.
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 3 inclusion and 18 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 20 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 3 sites in United States. 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 Plasma Concentration (Cmax) of Rocatinlimab (time frame: Up to approximately 112 days). 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 20 Jan 2026.