Trial Outcomes & Findings for A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER) (NCT NCT05899816)
NCT ID: NCT05899816
Last Updated: 2026-07-23
Results Overview
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
Week 20 to Week 24
Results posted on
2026-07-23
Participant Flow
A total of 221 participants were enrolled; however, data from 25 participants were excluded from all results analyses. Participant Flow data are therefore presented for a total of 196 participants.
The total duration of this trial for each individual participant was up to 40 weeks. This included a screening period of up to 4 weeks, a treatment period of 24 weeks, and a safety follow-up period of 16 weeks, following last dose of treatment at Week 20 (for participants not enrolled into the separate long-term maintenance trial \[protocol number 20210146, NCT05882877\]). Participants were randomized 2:1 to either rocatinlimab or placebo.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneously (SC) every 4 weeks (Q4W) for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose also given at Week 2.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
128
|
|
Overall Study
COMPLETED
|
58
|
113
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneously (SC) every 4 weeks (Q4W) for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose also given at Week 2.
|
|---|---|---|
|
Overall Study
Withdrawal of consent from trial
|
6
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
Baseline characteristics by cohort
| Measure |
Placebo
n=68 Participants
Participants received placebo SC Q4W for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
n=128 Participants
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose also given at Week 2.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.7 • n=9 Participants
|
37.4 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
36.8 years
STANDARD_DEVIATION 10.5 • n=267 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=9 Participants
|
75 Participants
n=27 Participants
|
124 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
53 Participants
n=27 Participants
|
72 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=9 Participants
|
38 Participants
n=27 Participants
|
58 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=9 Participants
|
90 Participants
n=27 Participants
|
138 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=9 Participants
|
32 Participants
n=27 Participants
|
50 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
65 Participants
n=27 Participants
|
100 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Week 20 to Week 24Population: Tetanus Vaccine Immune Response Analysis Set: Participants who missed no more than one dose of investigational product before vaccine administration at Week 20 and had anti-tetanus IgG antibody samples collected and reported at both Week 20 and Week 24.
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received placebo SC Q4W for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
n=105 Participants
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose at Week 2.
|
|---|---|---|
|
Percentage of Participants With a Positive Anti-tetanus Response at Week 24
|
92.3 percentage of participants
Interval 81.5 to 97.9
|
87.6 percentage of participants
Interval 79.8 to 93.2
|
PRIMARY outcome
Timeframe: Week 20 to Week 24Population: Meningococcal Vaccine Immune Response Analysis Set: Participants who missed no more than one dose of investigational product before vaccine administration at Week 20 and had anti-meningococcal IgG antibody samples collected and reported at both Week 20 and Week 24.
Participants received 1 dose of a meningococcal vaccine at Week 20. The antibody response to the meningococcal vaccine was assessed by measuring serum anti-meningococcal IgG by an immunoassay.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo SC Q4W for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
n=99 Participants
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose at Week 2.
|
|---|---|---|
|
Percentage of Participants With a Positive Anti-meningococcal Response at Week 24
|
53.2 percentage of participants
Interval 38.1 to 67.9
|
52.5 percentage of participants
Interval 42.2 to 62.7
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Rocatinlimab
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=68 participants at risk
Participants received placebo SC Q4W for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
n=128 participants at risk
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose also given at Week 2.
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
0.78%
1/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
0.78%
1/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
0.78%
1/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
0.78%
1/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
0.78%
1/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
0.78%
1/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
Other adverse events
| Measure |
Placebo
n=68 participants at risk
Participants received placebo SC Q4W for a duration of 24 weeks with a loading dose also given at Week 2.
|
Rocatinlimab
n=128 participants at risk
Participants received rocatinlimab 300 mg SC Q4W for 24 weeks with a loading dose also given at Week 2.
|
|---|---|---|
|
General disorders
Chills
|
0.00%
0/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
9.4%
12/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
General disorders
Pyrexia
|
1.5%
1/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
7.0%
9/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
|
Nervous system disorders
Headache
|
5.9%
4/68 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
3.1%
4/128 • For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the trial and included in the results analyses. Serious adverse events and other adverse events are reported for the safety analysis set, which included all participants who received at least one dose of trial drug and were included in the results analyses.
|
Additional Information
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