Atopic DermatitisPhase 1NCT06268860

A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants

A Phase 1 study testing Rocatinlimab vial injection and Rocatinlimab prefilled syringe in people with Atopic Dermatitis, run by Amgen at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy 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 vial injection and Rocatinlimab prefilled syringe
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 4 sitesin 2 countries
Study dates: 15 Feb 2024to 8 Oct 2024
Phase: Phase 1
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older 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 65 years of age (inclusive)
Body mass index between 18 and 32 kg/m^2 (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 electrocardiogram (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 pulse rate > 100 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 m^2

Show all 18Show fewer

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

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4903
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526

Other trials in United States

United Kingdom1 site

Fortrea Clinical Research Unit Limited - Leeds
Leeds, LDS, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Phase 1 Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects

The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.

Conditions: Atopic Dermatitis
Being tested: Rocatinlimab vial injection, Rocatinlimab prefilled syringe
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.

Rocatinlimab vial injectionDrug
Also called AMG 451
Vial solution for SC injection administered on Day 1
Rocatinlimab prefilled syringeCombination product
Also called AMG 451
Prefilled syringe solution for SC injection administered on Day 1

Study groups in NCT06268860
Study group	Role	What they receive
Rocatinlimab Vial	Experimental	Participants will receive rocatinlimab vial solution SC Receives: Drug: Rocatinlimab vial injection
Rocatinlimab Prefilled Syringe	Experimental	Participants will receive rocatinlimab prefilled syringe solution SC Receives: Combination Product: Rocatinlimab prefilled syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Concentration (Cmax) of Rocatinlimab
Pharmacokinetic (PK) parameters were determined from the serum concentrations of rocatinlimab using noncompartmental methods in a validated software program.
Measured: At predose on Day 1 and postdose on Day 1 through Day 112
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
PK parameters were determined from the serum concentrations of rocatinlimab using noncompartmental methods in a validated software program.
Measured: At predose on Day 1 and postdose on Days 1 through Day 112
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
PK parameters were determined from the serum concentrations of rocatinlimab using noncompartmental methods in a validated software program.
Measured: At predose on Day 1 and postdose on Days 1 through Day 112

Secondary outcomes (3)

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAE)
An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE that started during or after the dosing of trial treatment and up to the end of trial (EOT).
Measured: From first dose of trial drug until the end of trial; median (min, max) duration on trial was 16.0 (1.0, 20.3) weeks
Number of Participants Who Experienced Serious AEs (SAE)
An [JS12.1][MS12.2]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 AE that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect or important medical events that did not meet the preceding criteria but based on appropriate medical judgment could jeopardize the participant or could require medical or surgical intervention to prevent any of the outcomes listed.
Measured: From first dose of trial drug until the end of trial; median (min, max) duration on trial was 16.0 (1.0, 20.3) weeks
Number of Participants Positive to Anti-rocatinlimab Antibody
Blood samples were collected for anti-rocatinlimab antibody testing. The following results are reported:
- Participant with positive result at baseline;
- Participant with treatment-boosted antibody (the number of participants who were binding antibody positive at baseline and with an increase in titer greater than or equal to 4-fold from baseline);
- Participant with treatment-induced antibody positive result (are participants who were antibody-negative or had missing data at baseline but developed an antibody response after dosing);
- Participant with treatment-emergent antibody incidence (the sum of participants with treatment-boosted or treatment-induced antibody responses);
- Participant with treatment-induced neutralizing antibody positive result.
Measured: At predose on Day 1 and Days 28, 56 and 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 20248 Oct 2024

First posted20 Feb 2024
Study start15 Feb 2024
Primary completion30 Aug 2024
Study completion8 Oct 2024

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.
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: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06268860
Sponsor's protocol ID: 20220015
Status last verified: Jun 2026
First submitted: 13 Feb 2024
Last updated: 23 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects
ClinicalTrials.gov ID: NCT06268860
Acronym / sponsor ID: 20220015
Conditions: Atopic Dermatitis
Keywords: Rocatinlimab, AMG 451, Dermatology, Pharmacokinetics, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 15 Feb 2024 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 8 Oct 2024 (actual)
First posted: 20 Feb 2024 (actual)
Results: Posted 23 Oct 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 the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe 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
Rocatinlimab Vial	Experimental	Drug: Rocatinlimab vial injectionParticipants will receive rocatinlimab vial solution SC
Rocatinlimab Prefilled Syringe	Experimental	Combination Product: Rocatinlimab prefilled syringeParticipants will receive rocatinlimab prefilled syringe solution SC

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older 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 65 years of age (inclusive)
Body mass index between 18 and 32 kg/m^2 (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 electrocardiogram (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 pulse rate > 100 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
Rocatinlimab vial injectionAlso: AMG 451Vial solution for SC injection administered on Day 1	Drug	Rocatinlimab Vial
Rocatinlimab prefilled syringeAlso: AMG 451Prefilled syringe solution for SC injection administered on Day 1	Combination product	Rocatinlimab Prefilled Syringe

Primary outcome

Maximum Observed Serum Concentration (Cmax) of Rocatinlimab
Time frame: At predose on Day 1 and postdose on Day 1 through Day 112
Pharmacokinetic (PK) parameters were determined from the serum concentrations of rocatinlimab using noncompartmental methods in a validated software program.
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Time frame: At predose on Day 1 and postdose on Days 1 through Day 112
PK parameters were determined from the serum concentrations of rocatinlimab using noncompartmental methods in a validated software program.
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Time frame: At predose on Day 1 and postdose on Days 1 through Day 112
PK parameters were determined from the serum concentrations of rocatinlimab using noncompartmental methods in a validated software program.

3 secondary outcomes

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAE)
Time frame: From first dose of trial drug until the end of trial; median (min, max) duration on trial was 16.0 (1.0, 20.3) weeks
Number of Participants Who Experienced Serious AEs (SAE)
Time frame: From first dose of trial drug until the end of trial; median (min, max) duration on trial was 16.0 (1.0, 20.3) weeks
Number of Participants Positive to Anti-rocatinlimab Antibody
Time frame: At predose on Day 1 and Days 28, 56 and 112

Results and safety

Results posted to the registry on 23 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A: Rocatinlimab 300 mg/2 mL Vial	120	114
Treatment B: Rocatinlimab 300 mg/2 mL Prefilled Syringe	120	111

Primary outcome: Maximum Observed Serum Concentration (Cmax) of Rocatinlimab

Time frame: At predose on Day 1 and postdose on Day 1 through Day 112. Geometric mean (Geometric Coefficient of Variation). Unit: μg/mL

Measure	Treatment A: Rocatinlimab 300 mg/2 mL Vial n = 120	Treatment B: Rocatinlimab 300 mg/2 mL Prefilled Syringe n = 120
Value	36.3 (35.8)	36.0 (38.6)

Population analysed: PK population: included all participants who received at least 1 dose of rocatinlimab and had evaluable PK data.

Primary outcome: Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab

Time frame: At predose on Day 1 and postdose on Days 1 through Day 112. Geometric mean (Geometric Coefficient of Variation). Unit: h*μg/mL

Measure	Treatment A: Rocatinlimab 300 mg/2 mL Vial n = 115	Treatment B: Rocatinlimab 300 mg/2 mL Prefilled Syringe n = 114
Value	24800 (37.7)	25100 (39.5)

Population analysed: PK population: included all participants who received at least 1 dose of rocatinlimab and had evaluable PK data. Participants with data available are presented.

Primary outcome: AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab

Time frame: At predose on Day 1 and postdose on Days 1 through Day 112. Geometric mean (Geometric Coefficient of Variation). Unit: h*μg/mL

Measure	Treatment A: Rocatinlimab 300 mg/2 mL Vial n = 115	Treatment B: Rocatinlimab 300 mg/2 mL Prefilled Syringe n = 114
Value	25400 (37.1)	25700 (39.0)

Population analysed: PK population: included all participants who received at least 1 dose of rocatinlimab and had evaluable PK data. Participants with data available are presented.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For mortality reporting, from randomization until the end of trial; median (min, max) time on trail was 16.0 (1.0, 20.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration on trial was 16.0 (1.0, 20.3) weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Rocatinlimab 300 mg/2 mL Vial	1 of 120 (0.8%)	42 of 120 (35%)	0 of 120
Treatment B: Rocatinlimab 300 mg/2 mL Prefilled Syringe	1 of 120 (0.8%)	48 of 120 (40%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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RecruitingPhase 2
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RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
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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

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rocatinlimab vial injection and Rocatinlimab prefilled syringe in people with Atopic Dermatitis, run by Amgen at 4 sites in 2 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 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, United Kingdom. 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?

Yes. Results are posted in the registry (first posted 23 Oct 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?

Maximum Observed Serum Concentration (Cmax) of Rocatinlimab (time frame: At predose on Day 1 and postdose on Day 1 through Day 112). 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?

On the ClinicalTrials.gov record for NCT06268860.

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 23 Oct 2026.