The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body when used together with medicated creams or ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema (also called atopic dermatitis) is a common skin condition that makes the skin dry, itchy, red, and irritated. * This study is seeking participants who: Are aged 12 years or older. * Were confirmed to have atopic dermatitis (AD) at least 12 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. Participants in this study will randomly receive either tilrekimig or placebo at a 2:1 ratio. A placebo does not have any medicine in it but looks just like the medicine being studied. The study treatment period will be 24 weeks. The last dose of study treatment will be administered at week 20. Some participants will join the long-term extension study C4531008 at week 24. A long-term extension study is an additional study that participants may be able to join after completing the main study. It allows researchers to continue collecting information about how well the study medicine works and how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last study treatment dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
Subcutaneous Injections at required timepoints
Subcutaneous Injections at required timepoints
Northridge Clinical Trials
Northridge, California, United States
NOT_YET_RECRUITINGAllerVie Clinical Research
Panama City, Florida, United States
NOT_YET_RECRUITINGGCP Research , Global Clinical Professionals
St. Petersburg, Florida, United States
RECRUITINGDifference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of revised investigator's global assessment (rIGA) 0/1 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Eczema and Severity Index (EASI)90 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders between tilrekimig versus placebo
For participants \>= 16 yrs of age
Time frame: Week 16
Difference in the proportion of Peak Pruritus Numerical Rating Scale (PP-NRS)4 responders between tilrekimig versus placebo
Time frame: Weeks 2, 4, 6, 8, and 16
Difference in the mean percent change from baseline (CFB) in EASI total score, between tilrekimig versus placebo
Time frame: Week 16
Incidence of treatment emergent Adverse Events (AE)s, Serious Adverse Events (SAE)s and AEs leading to discontinuation
Time frame: For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention.
Incidence of clinically significant changes in vital signs, and laboratory tests
Time frame: For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention
Difference in the proportion of EASI75 responders
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the proportion of vIGA-AD™ 0/1 response
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the proportion of rIGA 0/1 response
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the proportion of vIGA-AD™ 0 response defined as achieving a vIGA-AD(™) score of clear (0) (on a 5-point scale)
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 36
Difference in the proportion of PP-NRS4 response at every week except those included as key secondary endpoints
Time frame: Week 1 through Week 24 (except Weeks 2, 4, 6, 8, and 16), plus Week 36
Difference in the proportion of EASI50, EASI90 and EASI100 (≥50%, ≥90% and 100% improvement from baseline in EASI)
Time frame: Time frame for both EASI50 and EASI100 is Weeks 2, 4, 8, 12, 16, 20, 24, and 36. Time frame for EASI90 is Weeks 2, 4, 8, 12, 20, 24, and 36.
Difference in the percent CFB in EASI total score
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the percent CFB in Body Surface Area (BSA)
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 36
Difference in the proportion of patient Oriented Eczema Measure (POEM) response based on a participant achieving ≥4-point improvement from baseline in POEM
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the proportion of DLQI response based on a participant achieving ≥4-point improvement from baseline in DLQI at scheduled time points except that included as a key secondary endpoint for participants 16 years or older
Time frame: Weeks 4, 8, 24 and 36
Difference in the proportion of patient global impression of disease severity (PGI-S) response based on a participant achieving a score of None or Mild (0 or 1) in PGI-S
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the proportion of patient global impression of change in clinical status (PGI-C) response based on a participant achieving "Much Better" in PGI-C
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the proportion of responders for Atopic Dermatitis Control Tool (ADCT) response based on a participant achieving ≥5-point improvement from baseline in ADCT
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in POEM
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in DLQI at scheduled time points for participants 16 years or older
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in Children's Dermatology Life Quality Index (CDLQI) at scheduled time points for participants 12 to <16 years of age
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in weekly averages of PP-NRS
Time frame: Week 1 through Week 24, plus Week 36
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