Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
Conditions
Keywords
Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab
Brief summary
The primary objectives of this study are to: * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24
Interventions
DRUGRocatinlimab
Subcutaneous (SC) injection
DRUGPlacebo
SC injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months * History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors) * Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. * Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3
Exclusion criteria
* Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 * Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: * Systemic corticosteroids * Systemic immunosuppressants * Phototherapy * Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week, prior to Day 1: * TCS of any potency * Topical calcineurin inhibitors (TCI) * Topical Phosphodiesterase-4 inhibitors (PDE4) * Other topical immunosuppressive agents * Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents * Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. * Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Positive Anti-tetanus Response at Week 24 | Week 20 to 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. |
| Percentage of Participants With a Positive Anti-meningococcal Response at Week 24 | Week 20 to 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. |
Countries
Canada, United States
Contacts
STUDY_DIRECTORMD
Amgen
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 27 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 100 Participants |
| Sex: Female, Male Female | 124 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 128 |
| other Total, other adverse events | 4 / 68 | 18 / 128 |
| serious Total, serious adverse events | 0 / 68 | 3 / 128 |
Outcome results
None listed