Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (NCT NCT05633355)

Last Updated: 2026-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

187 participants

Primary outcome timeframe

From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks

Results posted on

2026-07-24

Participant Flow

A total of 187 participants were enrolled at 59 trial centers located in Argentina, Australia, Brazil, Canada, Hong Kong, South Korea, Turkey, the United Kingdom and the United States between January 2023 and July 2025.

A total of 235 participants were screened, of which 187 were enrolled and received treatment with rocatinlimab.

Participant milestones

Participant milestones
Measure	Rocatinlimab All participants received open-label rocatinlimab 300 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks, with a loading dose of 300 mg at Week 2.
Overall Study STARTED	187
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Rocatinlimab All participants received open-label rocatinlimab 300 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks, with a loading dose of 300 mg at Week 2.
Overall Study Lost to Follow-up	6
Overall Study Withdrawal by Subject	21

Baseline Characteristics

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rocatinlimab n=187 Participants All participants received open-label rocatinlimab 300 mg administered subcutaneously Q4W for 52 weeks, with a loading dose of 300 mg at Week 2.
Age, Continuous	14.8 Years STANDARD_DEVIATION 1.8 • n=9 Participants
Sex: Female, Male Female	91 Participants n=9 Participants
Sex: Female, Male Male	96 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=9 Participants
Race/Ethnicity, Customized Asian	51 Participants n=9 Participants
Race/Ethnicity, Customized Black or African American	15 Participants n=9 Participants
Race/Ethnicity, Customized Multiple or More than one race	8 Participants n=9 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=9 Participants
Race/Ethnicity, Customized White	104 Participants n=9 Participants
Race/Ethnicity, Customized Other	5 Participants n=9 Participants

PRIMARY outcome

Timeframe: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks

Population: Safety analysis set: included all participants who received at least 1 dose of trial intervention.

Outcome measures

Outcome measures
Measure	Rocatinlimab n=187 Participants All participants received open-label rocatinlimab 300 mg administered subcutaneously Q4W for 52 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)	4 Participants

Adverse Events

Rocatinlimab

Serious events: 4 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rocatinlimab n=187 participants at risk All participants received open-label rocatinlimab 300 mg administered subcutaneously Q4W for 52 weeks, with a loading dose of 300 mg at Week 2.
Gastrointestinal disorders Crohn's disease	0.53% 1/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
General disorders Pyrexia	0.53% 1/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Infections and infestations Appendicitis	0.53% 1/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Infections and infestations Peritonitis	0.53% 1/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Injury, poisoning and procedural complications Intentional overdose	0.53% 1/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Nervous system disorders Tremor	0.53% 1/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.

Other adverse events

Other adverse events
Measure	Rocatinlimab n=187 participants at risk All participants received open-label rocatinlimab 300 mg administered subcutaneously Q4W for 52 weeks, with a loading dose of 300 mg at Week 2.
Gastrointestinal disorders Aphthous ulcer	10.2% 19/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Gastrointestinal disorders Mouth ulceration	5.3% 10/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Gastrointestinal disorders Nausea	5.3% 10/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
General disorders Chills	5.3% 10/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
General disorders Pyrexia	15.5% 29/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Infections and infestations COVID-19	7.0% 13/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Infections and infestations Influenza	7.0% 13/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Infections and infestations Nasopharyngitis	7.5% 14/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Infections and infestations Upper respiratory tract infection	10.2% 19/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Nervous system disorders Headache	20.9% 39/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Skin and subcutaneous tissue disorders Acne	5.3% 10/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.9% 11/187 • All-cause mortality: From enrollment to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. For AEs: From first dose of trial intervention to the end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks. All-cause mortality was reported for all participants enrolled/randomized in the trial. Serious adverse events and other AEs were reported for all participants who received at least one dose of trial intervention.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER